Back to resultsSafety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy (CAPEMCHAR)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Administration of embolization beads
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring doxorubicin, beads, embolization, chemoembolization, prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have given written informed consent.
- Patients must be affiliated to or benefit from a health insurance scheme.
- Patients with a high-risk prostate cancer with a Gleason score of 9-10 on the biopsy, candidate for a multimodal treatment with radical prostatectomy validated at the multidisciplinary meeting.
- Patients with a normal blood count.
- Patients with a normal liver function test.
- Patients with an electrocardiogram including left ventricle ejection fraction (ventricular scintigraphy or echocardiography) and an echocardiogram allowing us to rule out heart disease.
- Patient must be completely recovered from acute toxicities (such as stomatitis, neutropenia, thrombopenia and generalized infections) caused by a previous cytotoxic treatment.
- OMS/ECOG score≤1 (to guard against a possible loss of therapeutic opportunity related to a delay in surgery caused by chemo-embolization).
Exclusion Criteria:
- Patients who are taking part in another study.
- Patients in an exclusion period determined by a previous study.
- Patients under legal guardianship, curatorship or tutorship.
- Patients not in condition to be able to express his consent (e.g. patient undergoing psychiatric treatment with mental disorders)
- Patients who refuse to sign the consent form.
- Patients for whom it is impossible to give clear information. • Patient already has a metastatic disease.
- Patients who have contraindications for surgery.
- Patients with a rectal or vesicular collateral pathology that cannot be excluded or a collateral penile pathology which, by precaution, would not allow embolization (unknown effect on the erection in the event of arterial exclusion).
- Patients with a contraindication for magnetic resonance imaging (pacemaker incompatible with MRI, claustrophobia, metal apparatus, total hip prosthesis).
- Patients with a past history of aortobifemoral bypass procedure or other vascular surgery making endovascular access to the prostate arteries impossible.
- Patients with irreversible hemostasis disorder: TP < 50%, TCA > twice the control, Platelets < 60 G/L.
- Patients with contraindications as mentioned in the Summary of Product Characteristics for Doxorubicin.
Sites / Locations
- Nîmes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Patients undergoing transarterial embolization of the prostate
Transarterial prostatic chemoembolization, 2.5 mg doxorubicin
Transarterial prostatic chemoembolization, 5.0 mg doxorubicin
Transarterial prostatic chemoembolization, 10.0 mg doxorubicin
Arm Description
Three patients will undergo transarterial embolization of the prostate using unloaded beads.
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 2.5 mg of doxorubicin.
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 5.0 mg of doxorubicin.
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 10.0 mg of doxorubicin.
Outcomes
Primary Outcome Measures
Evaluation of safety of prostate embolization using unloaded beads.
The number of serious undesirable events will be noted during the embolization. The undesirable event noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
The number of serious undesirable events will be noted the day after embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using unloaded beads.
Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
The number of serious undesirable events will be noted after the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
The number of serious undesirable events will be noted after the embolization. The side effects noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
The number of serious undesirable events will be noted after the clinical embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Secondary Outcome Measures
Tolerance of prostate embolization using unloaded beads.
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin.
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin.
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin.
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Tolerance of prostate embolization using unloaded beads: Clavien-Dindo score
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin:Clavien-Dindo score
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: Clavien-Dindo score
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: Clavien-Dindo score
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Tolerance of prostate embolization using unloaded beads : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using unloaded beads : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using unloaded beads : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Prostate-specific antigen level in patients treated with unloaded beads.
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with unloaded beads.
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with unloaded beads.
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Biological checkup for patients treated with beads loaded with 2.5 mg of doxorubicine
The following levels will be tested : uric acid, potassium, creatinin, calcium. phosphate)
Biological checkup for patients treated with beads loaded with 5.0 mg of doxorubicine
The following levels will be tested : uric acid, potassium, creatinin, calcium.
Biological checkup for patients treated with beads loaded with 10.0 mg of doxorubicine
The following levels will be tested : uric acid, potassium, creatinin, calcium.
Complete blood count for patients treated with beads loaded with 2.5 mg of doxorubicine
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Complete blood count for patients treated with beads loaded with 5.0 mg of doxorubicine
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Complete blood count for patients treated with beads loaded with 10.0 mg of doxorubicine
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Liver test for patients treated with beads loaded with 2.5 mg of doxorubicine
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Liver test for patients treated with beads loaded with 5.0 mg of doxorubicine
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Liver test for patients treated with beads loaded with 10.0 mg of doxorubicine
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 2.5 mg of doxorubicine
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 5.0 mg of doxorubicine
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 10.0 mg of doxorubicine
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Systemic dosage of free doxorubicin in blood in patients treated with beads loaded with 2.5 mg of doxorubicine
A blood sample will be taken and the concentration of doxorubicin will be measured in mg/m2
Full Information
NCT ID
NCT04423913
First Posted
June 5, 2020
Last Updated
March 23, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT04423913
Brief Title
Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy
Acronym
CAPEMCHAR
Official Title
Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.
The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.
The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
doxorubicin, beads, embolization, chemoembolization, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This is a purely descriptive, non randomized, non controlled, prospective sequential-type pilot study on the first use in the indication for prostatic arterial embolization using beads loaded with doxorubicin in increasing doses: 0 mg, 2.5mg, 5 mg and 10 mg. It is a study with escalating doses of doxorubicin : 3 patients with non-loaded beads, 3 patients with beads loaded at 2.5 mg (1/20 of the dose administered for liver tumors), 3 patients with beads loaded at 5mg and 3 patients with beads loaded at 10mg.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing transarterial embolization of the prostate
Arm Type
Experimental
Arm Description
Three patients will undergo transarterial embolization of the prostate using unloaded beads.
Arm Title
Transarterial prostatic chemoembolization, 2.5 mg doxorubicin
Arm Type
Experimental
Arm Description
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 2.5 mg of doxorubicin.
Arm Title
Transarterial prostatic chemoembolization, 5.0 mg doxorubicin
Arm Type
Experimental
Arm Description
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 5.0 mg of doxorubicin.
Arm Title
Transarterial prostatic chemoembolization, 10.0 mg doxorubicin
Arm Type
Experimental
Arm Description
Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 10.0 mg of doxorubicin.
Intervention Type
Other
Intervention Name(s)
Administration of embolization beads
Intervention Description
Patients will receive embolization beads, loaded with doxorubicin or not.
Primary Outcome Measure Information:
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
The number of serious undesirable events will be noted during the embolization. The undesirable event noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 0 (i.e. on the day of the intervention)
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
The number of serious undesirable events will be noted the day after embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 1 (i.e. one day after the intervention)
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 5 (i.e. 5 days after the intervention)
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 14 (i.e. 2 weeks after the intervention)
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 30 (i.e. 1 month after the intervention)
Title
Evaluation of safety of prostate embolization using unloaded beads.
Description
Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Three months after the intervention
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 0 (i.e. on the day of the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
The number of serious undesirable events will be noted after the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 1 (i.e. one day after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 5 (i.e. 5 days after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 14 (i.e. 2 weeks after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 30 (i.e. 1 month after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Three months after the intervention
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 0 (i.e. on the day of the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted after the embolization. The side effects noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 1 (i.e. one day after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 5 (i.e. 5 days after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 14 (i.e. 2 weeks after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 30 (i.e. 1 month after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
3 months after the intervention
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 0 (i.e. on the day of the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted after the clinical embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 1 (i.e. one day after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 5 (i.e. 5 days after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 14 (i.e. 2 weeks after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Day 30 (i.e. 1 month after the intervention)
Title
Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin
Description
Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever.
Time Frame
Three months after the intervention
Secondary Outcome Measure Information:
Title
Tolerance of prostate embolization using unloaded beads.
Description
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin.
Description
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin.
Description
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin.
Description
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area.
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads: Clavien-Dindo score
Description
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin:Clavien-Dindo score
Description
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: Clavien-Dindo score
Description
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: Clavien-Dindo score
Description
Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess…
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 30 (i.e. one month after embolization)
Title
Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Three months after embolization
Title
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 14
Title
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 30 i.e. 1 month after embolization
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score
Description
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using unloaded beads : IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 30 (i.e. one month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Three months after embolization)
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Day 30 (i.e.1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score
Description
The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score
Description
The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using unloaded beads : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 14
Title
Tolerance of prostate embolization using unloaded beads : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using unloaded beads : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 30 (1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Three months after embolization)
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Three months after embolization
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 14
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Day 30 (1 month after embolization)
Title
Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test
Description
The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours.
Time Frame
Three months after embolization
Title
Prostate-specific antigen level in patients treated with unloaded beads.
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 14 before surgery
Title
Prostate-specific antigen level in patients treated with unloaded beads.
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Prostate-specific antigen level in patients treated with unloaded beads.
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Three months after embolization
Title
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 14 before surgery
Title
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Three months after embolization
Title
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 14 before surgery
Title
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 30 (i.e. month after embolization)
Title
Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Three months after embolization
Title
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 14
Title
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Day 30 (i.e. 1 month after embolization)
Title
Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine .
Description
This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer.
Time Frame
Three months after embolization
Title
Biological checkup for patients treated with beads loaded with 2.5 mg of doxorubicine
Description
The following levels will be tested : uric acid, potassium, creatinin, calcium. phosphate)
Time Frame
Three months after embolization
Title
Biological checkup for patients treated with beads loaded with 5.0 mg of doxorubicine
Description
The following levels will be tested : uric acid, potassium, creatinin, calcium.
Time Frame
Three months after embolization
Title
Biological checkup for patients treated with beads loaded with 10.0 mg of doxorubicine
Description
The following levels will be tested : uric acid, potassium, creatinin, calcium.
Time Frame
Three months after embolization
Title
Complete blood count for patients treated with beads loaded with 2.5 mg of doxorubicine
Description
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Time Frame
Three months after embolization
Title
Complete blood count for patients treated with beads loaded with 5.0 mg of doxorubicine
Description
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Time Frame
Three months after embolization
Title
Complete blood count for patients treated with beads loaded with 10.0 mg of doxorubicine
Description
The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means.
Time Frame
Three months after embolization
Title
Liver test for patients treated with beads loaded with 2.5 mg of doxorubicine
Description
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Time Frame
Three months after embolization
Title
Liver test for patients treated with beads loaded with 5.0 mg of doxorubicine
Description
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Time Frame
Three months after embolization
Title
Liver test for patients treated with beads loaded with 10.0 mg of doxorubicine
Description
The following elements will be measured and compared with the test results before treatment :
Aspartate aminotransaminase (ASAT), alanine aminotransferase (ALAT)
bilirubin
Time Frame
Three months after embolization
Title
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 2.5 mg of doxorubicine
Description
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Time Frame
Three months after embolization
Title
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 5.0 mg of doxorubicine
Description
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Time Frame
Three months after embolization
Title
Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 10.0 mg of doxorubicine
Description
The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume).
Time Frame
Three months after embolization
Title
Systemic dosage of free doxorubicin in blood in patients treated with beads loaded with 2.5 mg of doxorubicine
Description
A blood sample will be taken and the concentration of doxorubicin will be measured in mg/m2
Time Frame
Day 1
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
As the study relates to embolization of prostate cancer, only male patients are concerned.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have given written informed consent.
Patients must be affiliated to or benefit from a health insurance scheme.
Patients with a high-risk prostate cancer with a Gleason score of 9-10 on the biopsy, candidate for a multimodal treatment with radical prostatectomy validated at the multidisciplinary meeting.
Patients with a normal blood count.
Patients with a normal liver function test.
Patients with an electrocardiogram including left ventricle ejection fraction (ventricular scintigraphy or echocardiography) and an echocardiogram allowing us to rule out heart disease.
Patient must be completely recovered from acute toxicities (such as stomatitis, neutropenia, thrombopenia and generalized infections) caused by a previous cytotoxic treatment.
OMS/ECOG score≤1 (to guard against a possible loss of therapeutic opportunity related to a delay in surgery caused by chemo-embolization).
Exclusion Criteria:
Patients who are taking part in another study.
Patients in an exclusion period determined by a previous study.
Patients under legal guardianship, curatorship or tutorship.
Patients not in condition to be able to express his consent (e.g. patient undergoing psychiatric treatment with mental disorders)
Patients who refuse to sign the consent form.
Patients for whom it is impossible to give clear information. • Patient already has a metastatic disease.
Patients who have contraindications for surgery.
Patients with a rectal or vesicular collateral pathology that cannot be excluded or a collateral penile pathology which, by precaution, would not allow embolization (unknown effect on the erection in the event of arterial exclusion).
Patients with a contraindication for magnetic resonance imaging (pacemaker incompatible with MRI, claustrophobia, metal apparatus, total hip prosthesis).
Patients with a past history of aortobifemoral bypass procedure or other vascular surgery making endovascular access to the prostate arteries impossible.
Patients with irreversible hemostasis disorder: TP < 50%, TCA > twice the control, Platelets < 60 G/L.
Patients with contraindications as mentioned in the Summary of Product Characteristics for Doxorubicin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Organizational Affiliation
CHU de Nîmes, Place du Professeur Debré, 30029 Nîmes Cedex
Official's Role
Study Director
Facility Information:
Facility Name
Nîmes University Hospital
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Distribution & Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients Before Radical Prostatectomy
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