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Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer (FOCALE)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
treatment with focal HIFU
PSA dosage
MRI
Questionnaires
Prostatic biopsies
blood test
urine test
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, HIFU focal, adverse effect, intermediate risk

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
  • Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
  • Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:

    • A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
    • Gleason score= 7 (3+4).
    • Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
  • PSA ≤ 15ng / ml.
  • Patient affiliated with health insurance or beneficiary of an equivalent plan.

Exclusion Criteria:

  • Contraindications to treatment with HIFU-F:

    • Tumor not accessible.
    • Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
    • History of pelvic irradiation
    • Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
    • Fistula of the urinary tract or rectum.
    • Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
    • Anatomical abnormality of the rectum or rectal mucosa.
    • Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
    • History of intestinal inflammatory pathology.
    • Uro-genital infection in progress (the infection to be treated before HIFU treatment).
    • Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
    • Allergy to latex.
    • Thickness of the rectal wall> 10mm.
  • TURP indication. Bladder neck incision is allowed.
  • Patient with a medical contraindication to Sonovue® injection.
  • Patient with a medical contraindication on MRI.
  • Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
  • History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
  • History of pelvic radiotherapy.
  • History of sclerosis of the bladder neck or urethral stenosis.
  • Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy).
  • Patients with unstable neurological pathology.
  • Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
  • Legal person protected by law.
  • Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.

Sites / Locations

  • Polyclinique du parc RambotRecruiting
  • Clinique Saint-Vincent
  • Service d'Urologie, Clinique Tivoli DucosRecruiting
  • Groupe Hospitalier Pellegrin - CHURecruiting
  • Hôpital L. Pasteur, Hôpitaux Civils de ColmarRecruiting
  • Service d'Urologie CHRU de Lille, Hôpital HURIEZRecruiting
  • Service d'Urologie Générale de Santé - Hôpital Privé La LouvièreRecruiting
  • Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,Recruiting
  • Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille NordRecruiting
  • Département d'Urologie, Institut MontsourisRecruiting
  • Centre Hospitalier Lyon Sud - Hospices Civils de LyonRecruiting
  • Clinique Urologique Nantes Atlantis
  • Service d'Urologie, Hôpital FochRecruiting
  • CHU de Toulouse - Hôpital de RangueilRecruiting
  • Clinique Générale Beaulieu - Swiss International Prostate Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU treatment

Arm Description

170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.

Outcomes

Primary Outcome Measures

patient proportion with controlled disease (Control of the pathology)
The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.

Secondary Outcome Measures

proportion of patients needing additional treatment
The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 12 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.
proportion of patients needing additional treatment
The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 48 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.
proportion of patients needing additional radical treatment
The objective is to determine the proportion of patients needing additional radical treatment at 12 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.
proportion of patients needing additional radical treatment
The objective is to determine the proportion of patients needing additional radical treatment at 48 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.
rate of positive biopsies
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 12 months.
rate of positive biopsies
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 24 months.
rate of positive biopsies
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 48 months.
clinically significant cancer rate
The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the carcinologic evolution at 48 months.
Gleason score
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 12 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Gleason score
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 24 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Gleason score
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 48 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Appearance of another cancerous focus in the other half of the prostate
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Appearance of another cancerous focus in the other half of the prostate
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Appearance of another cancerous focus in the other half of the prostate
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Appearance of metastases
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Appearance of metastases
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Appearance of metastases
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Appearance of an extra capsular extension
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Appearance of an extra capsular extension
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Appearance of an extra capsular extension
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Overall survival
Overall survival at 48 months will be measured from the date of inclusion to the date of death, all causes of death combined or the date of last new or point date to 48 months.
Prostate cancer specific survival
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of death related to prostate cancer or the date of last new or point date to 48 months
Recurrence free survival
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of first metastasis , or the date of last new or point date to 48 months.
Proportion of serious adverse effect
comparison of the proposition of serious adverse effect at 48 months
Quality of life score
quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the better the quality of life.
EPIC-26 score
urinary function will be assessed using the EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. The EPIC-26 is a self-reported scale health-related quality of life questionnaire for prostate cancer patients . It is composed of 26 items in 4 different domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Each items as a standardized value from 0 to 100. Then the average of the standardized value is determined in each domain to crate the summary score. The higher the score, the better the quality of life.
IPSS score
urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
IIEF-5 score
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
patient proportion with controlled disease (Control of the pathology)
The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 48 months after inclusion.
Ancillary study: Measure of anti-tumoral immunity induction
The consequences of HIFU treatment over immune anti-tumoral induction will be estimated by the description of Programmed death-ligand 1/ligand 2 (PDL1/L2) overexpression on immune cells and overexpression of Programmed cell death 1 (PD-1) on T lymphocytes (T-cells).
Ancillary study: Measure of Circulating Tumor Cells (CTC) number reduction
The consequences of HIFU treatment over Messenger RNA (mRNA) will be estimated by measure of CTC number reduction.
Ancillary study: Measure of ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level reduction.
The consequences of HIFU treatment over PCA3 will be estimated by measure of ncRNA PCA3 level reduction.

Full Information

First Posted
June 6, 2018
Last Updated
March 15, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03568188
Brief Title
Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer
Acronym
FOCALE
Official Title
Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
September 28, 2022 (Anticipated)
Study Completion Date
September 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, HIFU focal, adverse effect, intermediate risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFU treatment
Arm Type
Experimental
Arm Description
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
Intervention Type
Procedure
Intervention Name(s)
treatment with focal HIFU
Intervention Description
HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.
Intervention Type
Biological
Intervention Name(s)
PSA dosage
Intervention Description
PSA dosage will be regularly performed during patient follow up thanks to blood sampling.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI exam will be regularly performed during patient follow up.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function).
Intervention Type
Procedure
Intervention Name(s)
Prostatic biopsies
Intervention Description
Prostatic biopsies will be regularly performed during patient follow up.
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Description
if the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) will be performed during their follow up.
Intervention Type
Biological
Intervention Name(s)
urine test
Intervention Description
if the patient decides to participate in the ancillary study, a urine test (for PCA3 test) will be performed during their follow up.
Primary Outcome Measure Information:
Title
patient proportion with controlled disease (Control of the pathology)
Description
The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
proportion of patients needing additional treatment
Description
The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 12 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.
Time Frame
12 months
Title
proportion of patients needing additional treatment
Description
The objective is to determine the proportion of patients needing additional treatment (focal or radical) at 48 months. This includes patients who wish or require radical treatment (prostatectomy, radiotherapy), total focal treatment, or additional focal treatment.
Time Frame
48 months
Title
proportion of patients needing additional radical treatment
Description
The objective is to determine the proportion of patients needing additional radical treatment at 12 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.
Time Frame
12 months
Title
proportion of patients needing additional radical treatment
Description
The objective is to determine the proportion of patients needing additional radical treatment at 48 months. This includes patients who wish or require prostatectomy or radiotherapy total focal treatment.
Time Frame
48 months
Title
rate of positive biopsies
Description
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 12 months.
Time Frame
12 months
Title
rate of positive biopsies
Description
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 24 months.
Time Frame
24 months
Title
rate of positive biopsies
Description
The rate of positive biopsies in the untreated lobe and treated lobe evaluated and will be used to evaluate the carcinologic evolution at 48 months.
Time Frame
48 months
Title
clinically significant cancer rate
Description
The clinically significant cancer rate (Gleason 7 or invasion of more than 3 biopsies or invasion> 3 mm regardless of Gleason) in the untreated lobe and the treated lobe will be measured and will be used to evaluate the carcinologic evolution at 48 months.
Time Frame
48 months
Title
Gleason score
Description
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 12 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Time Frame
12 months
Title
Gleason score
Description
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 24 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Time Frame
24 months
Title
Gleason score
Description
Evolution of the Gleason score (appearance of Gleason ≥7) will be measured and will be used to evaluate the carcinologic evolution at 48 month. The Gleason score is a prognosis factor for prostate cancer. It is based prostate cancer cells architecture from biopsies. The more the architectures of prostate cancer cell is destroyed, the worse is the prognosis. The score grades from 3 to 5, 5 being the more destroyed, the score 1 and 2 being normal cells. When there is more than one tumor cells population in the prostate, the score is composed of the sum of the most 2 frequents grade. For example a Gleason 7 tumor could be 3+4 or 4+3, the 4+3 being more aggressive.
Time Frame
48 months
Title
Appearance of another cancerous focus in the other half of the prostate
Description
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Time Frame
12 months
Title
Appearance of another cancerous focus in the other half of the prostate
Description
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Time Frame
24 months
Title
Appearance of another cancerous focus in the other half of the prostate
Description
Appearance of another cancerous focus in the other half of the prostate will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Time Frame
48 months
Title
Appearance of metastases
Description
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Time Frame
12 months
Title
Appearance of metastases
Description
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Time Frame
24 months
Title
Appearance of metastases
Description
Appearance of metastases (lymph node or bone) will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Time Frame
48 months
Title
Appearance of an extra capsular extension
Description
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 12 months.
Time Frame
12 months
Title
Appearance of an extra capsular extension
Description
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 24 months.
Time Frame
24 months
Title
Appearance of an extra capsular extension
Description
Appearance of an extra capsular extension will be supervised and will be used to evaluate the carcinologic evolution at 48 months.
Time Frame
48 months
Title
Overall survival
Description
Overall survival at 48 months will be measured from the date of inclusion to the date of death, all causes of death combined or the date of last new or point date to 48 months.
Time Frame
48 months
Title
Prostate cancer specific survival
Description
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of death related to prostate cancer or the date of last new or point date to 48 months
Time Frame
48 months
Title
Recurrence free survival
Description
Prostate cancer specific survival at 48 months will be measured from the date of inclusion to the date of first metastasis , or the date of last new or point date to 48 months.
Time Frame
48 months
Title
Proportion of serious adverse effect
Description
comparison of the proposition of serious adverse effect at 48 months
Time Frame
48 months
Title
Quality of life score
Description
quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the better the quality of life.
Time Frame
over the 48 months
Title
EPIC-26 score
Description
urinary function will be assessed using the EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. The EPIC-26 is a self-reported scale health-related quality of life questionnaire for prostate cancer patients . It is composed of 26 items in 4 different domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Each items as a standardized value from 0 to 100. Then the average of the standardized value is determined in each domain to crate the summary score. The higher the score, the better the quality of life.
Time Frame
over the 48 months
Title
IPSS score
Description
urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Time Frame
over the 48 months
Title
IIEF-5 score
Description
Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire. The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high). The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Time Frame
over the 48 months
Title
patient proportion with controlled disease (Control of the pathology)
Description
The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 48 months after inclusion.
Time Frame
48 months
Title
Ancillary study: Measure of anti-tumoral immunity induction
Description
The consequences of HIFU treatment over immune anti-tumoral induction will be estimated by the description of Programmed death-ligand 1/ligand 2 (PDL1/L2) overexpression on immune cells and overexpression of Programmed cell death 1 (PD-1) on T lymphocytes (T-cells).
Time Frame
over the 48 months
Title
Ancillary study: Measure of Circulating Tumor Cells (CTC) number reduction
Description
The consequences of HIFU treatment over Messenger RNA (mRNA) will be estimated by measure of CTC number reduction.
Time Frame
over the 48 months
Title
Ancillary study: Measure of ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level reduction.
Description
The consequences of HIFU treatment over PCA3 will be estimated by measure of ncRNA PCA3 level reduction.
Time Frame
over the 48 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study. Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14. Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics: A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies. Gleason score= 7 (3+4). Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter PSA ≤ 15ng / ml. Patient affiliated with health insurance or beneficiary of an equivalent plan. Exclusion Criteria: Contraindications to treatment with HIFU-F: Tumor not accessible. Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment. History of pelvic irradiation Presence of an implant (stent, catheter) located less than 1 cm from the treatment area. Fistula of the urinary tract or rectum. Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe. Anatomical abnormality of the rectum or rectal mucosa. Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent. History of intestinal inflammatory pathology. Uro-genital infection in progress (the infection to be treated before HIFU treatment). Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible. Allergy to latex. Thickness of the rectal wall> 10mm. TURP indication. Bladder neck incision is allowed. Patient with a medical contraindication to Sonovue® injection. Patient with a medical contraindication on MRI. Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery). History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer). History of pelvic radiotherapy. History of sclerosis of the bladder neck or urethral stenosis. Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy). Patients with unstable neurological pathology. Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study. Legal person protected by law. Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien CROUZET, Pr
Phone
04 72 11 03 25
Ext
+33
Email
sebastien.crouzet@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BERTHILLER, study manager
Phone
04 72 11 80 67
Ext
+33
Email
julien.berthiller@chu-lyon.fr
Facility Information:
Facility Name
Polyclinique du parc Rambot
City
Aix-en-Provence
ZIP/Postal Code
13100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric ANFOSSI, MD, PhD
Phone
04 42 96 53 40
Ext
+33
Email
eric.anfossi@wanadoo.fr
First Name & Middle Initial & Last Name & Degree
David BARRIOL, MD, PhD
Phone
04 42 96 53 40
Ext
+33
Email
david.barriol@gmail.com
First Name & Middle Initial & Last Name & Degree
David BARRIOL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eric ANFOSSI, MD, PhD
Facility Name
Clinique Saint-Vincent
City
Besançon
ZIP/Postal Code
25044
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BAILLY, MD, PhD
Phone
03 10 00 14 80
Ext
+33
Email
dr.bailly@mon-urologue.fr
First Name & Middle Initial & Last Name & Degree
Vincent BAILLY, MD, PhD
Facility Name
Service d'Urologie, Clinique Tivoli Ducos
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles PASTICIER, MD, PhD
Phone
05 56 11 61 44
Ext
+33
Email
gillespasticier@gmail.com
First Name & Middle Initial & Last Name & Degree
Gilles PASTICIER, MD, PhD
Facility Name
Groupe Hospitalier Pellegrin - CHU
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck BLADOU, PU, PH
Phone
05 57 82 03 40
Ext
+33
Email
franck.bladou@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Franck BLADOU, PU, PH
Facility Name
Hôpital L. Pasteur, Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovic OBRINGER, MD, PhD
Phone
03 89 12 45 20
Ext
+33
Email
obringerl@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Ludovic OBRINGER, MD, PhD
Facility Name
Service d'Urologie CHRU de Lille, Hôpital HURIEZ
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud VILLIERS, PH
Phone
03 20 44 42 35
Ext
+33
Email
arnauld.villers@wanadoo.fr
First Name & Middle Initial & Last Name & Degree
Arnaud VILLIERS, PH
Facility Name
Service d'Urologie Générale de Santé - Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre COLIN, MD, PhD
Phone
08 26 30 70 00
Ext
+33
Email
docpierrecolin@gmail.com
First Name & Middle Initial & Last Name & Degree
Pierre COLIN, MD, PhD
Facility Name
Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot,
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien CROUZET, Pr.
Phone
04 72 11 03 25
Ext
+33
Email
sebastien.crouzet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Julien BERTHILLER
Phone
04 72 11 80 67
Ext
+33
Email
julien.berthiller@chu-lyon.fr
Facility Name
Service d'urologie Assistance Publique - Hôpitaux de Marseille - Hôpital Marseille Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry TOLEDANO, MD, PHD
Phone
06 62 69 87 38
Ext
+33
Email
harry.toledano@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Harry TOLEDANO, MD, PHD
Facility Name
Département d'Urologie, Institut Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael SANCHEZ SALAS, MD, PhD
Phone
01 56 61 66 18
Ext
+33
Email
rafael.sanchez-salas@imm.fr
First Name & Middle Initial & Last Name & Degree
Rafael SANCHEZ SALAS, MD, PhD
Facility Name
Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, Pu,PH
Phone
04 72 67 88 08
Ext
+33
Email
alain.ruffion@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Alain RUFFION, Pu,PH
Facility Name
Clinique Urologique Nantes Atlantis
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric POTIRON, MD, PhD
Phone
02 28 03 04 44
Ext
+33
Email
potironeric@neuf.fr
First Name & Middle Initial & Last Name & Degree
Eric POTIRON, MD, PhD
Facility Name
Service d'Urologie, Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek GHONEIM, MD, PhD
Phone
01 46 25 25 25
Ext
+33
Email
t.ghoneim@hopital-foch.org
First Name & Middle Initial & Last Name & Degree
Tarek GHONEIM, MD, PhD
Facility Name
CHU de Toulouse - Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal RISCHMANN, PH
Phone
05 61 32 25 33
Ext
+33
Email
rischmann.p@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Pascal RISCHMANN, PH
Facility Name
Clinique Générale Beaulieu - Swiss International Prostate Center
City
Geneva
ZIP/Postal Code
1206
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REGUSCI Stefano, MD, PhD
Phone
22 343 92 12
Ext
+41
Email
regusci@bluewin.ch
First Name & Middle Initial & Last Name & Degree
REGUSCI Stefano, MD, PhD

12. IPD Sharing Statement

Links:
URL
http://www.rhu-perfuse.fr/homepage/WP1-clinique.html
Description
Related Info

Learn more about this trial

Efficacy Evaluation of Focused HIFU (High Intensity Focused Ultrasound) Therapy in Patients With Localized Intermediate Risk Prostate Cancer

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