Back to resultsStudy of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
Primary Purpose
Low Risk Prostate Cancer
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
TOOKAD VTP
Sponsored by
About this trial
This is an interventional treatment trial for Low Risk Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
Men over 18 years of age with a life expectancy ≥ 10 years
-.Unilateral adenocarcinoma of the prostate accurately located and confirmed as unilateral using high resolution biopsy strategies based on current best practice, such as multi- parametric MRI based strategies or template-based biopsy procedures.
- Clinical stage T1c or T2a,
- Gleason Score ≤ 6, based on high-resolution biopsy strategies
- 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1 -2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
- PSA ≤ 10 ng/mL
- If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
- Signed Informed Consent Form
Exclusion Criteria:
GENERAL EXCLUSION CRITERIA :
- Unwillingness to accept the treatment;
- Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
- Participation in another clinical study involving an investigational product within 1 month before study entry;
- Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
- Subjects in custody and or residing in a nursing home or rehabilitation facility;
- Biopsy proven locally advanced or metastatic prostate cancer.
SURGERY AND OTHER TREATMENT-RELATED CONDITIONS OF EXCLUSION
- Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject or any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
- Hypersensitivity to the active substance or to the excipient (mannitol)
- Current or prior treatment for prostate cancer.
- Patients who have been diagnosed with cholestasis.
- Current exacerbation of rectal inflammatory bowel disease.
- Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD. Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Sites / Locations
- Centre Hospitalier Universitaire (CHU)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TOOKAD VTP
Arm Description
TOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.
Outcomes
Primary Outcome Measures
Cumulated time with toxicity (duration)
Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Cumulated time with toxicity (prevalence)
Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.
Cumulated time with toxicity (area under the curve)
Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Secondary Outcome Measures
Time with erectile dysfunction (duration)
Time to onset, duration, time to resolution of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time with erectile dysfunction (prevalence)
Prevalence at different points in time of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time with erectile dysfunction (Area under the curve)
Area under the curve with the presence of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time with urinary incontinence (duration)
Time to onset, duration, time to resolution of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument,
Time with urinary incontinence (prevalence)
Prevalence at different points in time of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Time with urinary incontinence (Area under the curve)
Area under the curve with the presence of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Correspondence between results of EPIC and IIEF instruments
Average variation on urinary symptoms (UI) using the EPIC and IPSS instruments, erectile functions (ED) using the EPIC and IIEF instruments, and bowel function using the EPIC instrument, prior to treatment beginning and then at 1, 2, 3, 6 and 12 months after completing treatment: absolute scores and changes as compared to baseline (absolute difference of means and proportion change)
PSA density
Average changes from baseline in PSA density at month 12
Rate of Adverse Events
Rate of adverse events (AE) of TOOKAD® VTP treatment : all AE, important AE identified in Risk Management Plan (RMP) and suspected AE listed in RMP.
Time to resolution of Adverse events
Time to resolution of adverse events for each adverse event reported
Additional prostate cancer treatments
Rate of additional treatment as decided by local practice, such as radical therapy (surgical removal of the prostate gland, radiation treatment to the prostate gland) or other intervention therapy to the ipsilateral and/or contralateral lobe, use of hormone or chemotherapies.
Extension of prostate cancer
Rate of reported extension of prostate cancer based on locally decided investigations (such as clinical examination, biopsy, Magnetic resonance Imaging (MRI), other).
Full Information
NCT ID
NCT03849365
First Posted
January 24, 2019
Last Updated
March 18, 2021
Sponsor
Steba Biotech S.A.
Collaborators
International Drug Development Institute, PrimeVigilance LTD
1. Study Identification
Unique Protocol Identification Number
NCT03849365
Brief Title
Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
Official Title
Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Early end of enrolment with regards to difficulty met to enrol patients
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
November 13, 2020 (Actual)
Study Completion Date
November 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steba Biotech S.A.
Collaborators
International Drug Development Institute, PrimeVigilance LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.
Detailed Description
This is a multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial. Men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the EEA Marketing Authorisation) will receive TOOKAD® VTP under general anesthesia. The primary objective is to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP. Prior to the TOOKAD® VTP, patients will undergo routine ultrasound examination in the operating room for morphometric description of the prostate and to facilitate accurate treatment guidance for the treatment with TOOKAD® VTP. Treatment will then be applied to the prostate gland as a hemi-ablation procedure designed to destroy the lobe of the prostate gland that contains the cancer. Afterwards, patients will be followed for 12 months with clinical evaluation, data collection on erectile and urinary functions at 1, 2, 3 6 and 12 months, using the Expanded Prostate Cancer Index Composite (EPIC), International Index of Erectile Function (IIEF) and International Prostate Score Symptom (IPSS) questionnaires on Quality Of Life (QOL) and Prostate Specific Antigen (PSA) testing at 3, 6 and 12 months.
The clinical follow-up of patients will follow local standard of care processes, based on recommendations in the European Summary of Product Characteristics (SmPC).
This study is a phase IV pragmatic trial using optimal dose of TOOKAD® and optimal light-energy level conditions that were determined during development and approved by the European Commission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Risk Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TOOKAD VTP
Arm Type
Experimental
Arm Description
TOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.
Intervention Type
Drug
Intervention Name(s)
TOOKAD VTP
Intervention Description
TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.
Primary Outcome Measure Information:
Title
Cumulated time with toxicity (duration)
Description
Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Time Frame
12 months
Title
Cumulated time with toxicity (prevalence)
Description
Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.
Time Frame
12 months
Title
Cumulated time with toxicity (area under the curve)
Description
Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time with erectile dysfunction (duration)
Description
Time to onset, duration, time to resolution of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time Frame
12 months
Title
Time with erectile dysfunction (prevalence)
Description
Prevalence at different points in time of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time Frame
12 months
Title
Time with erectile dysfunction (Area under the curve)
Description
Area under the curve with the presence of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Time Frame
12 months
Title
Time with urinary incontinence (duration)
Description
Time to onset, duration, time to resolution of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument,
Time Frame
12 months
Title
Time with urinary incontinence (prevalence)
Description
Prevalence at different points in time of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Time Frame
12 months
Title
Time with urinary incontinence (Area under the curve)
Description
Area under the curve with the presence of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Time Frame
12 months
Title
Correspondence between results of EPIC and IIEF instruments
Description
Average variation on urinary symptoms (UI) using the EPIC and IPSS instruments, erectile functions (ED) using the EPIC and IIEF instruments, and bowel function using the EPIC instrument, prior to treatment beginning and then at 1, 2, 3, 6 and 12 months after completing treatment: absolute scores and changes as compared to baseline (absolute difference of means and proportion change)
Time Frame
12 months
Title
PSA density
Description
Average changes from baseline in PSA density at month 12
Time Frame
12 months
Title
Rate of Adverse Events
Description
Rate of adverse events (AE) of TOOKAD® VTP treatment : all AE, important AE identified in Risk Management Plan (RMP) and suspected AE listed in RMP.
Time Frame
12 months
Title
Time to resolution of Adverse events
Description
Time to resolution of adverse events for each adverse event reported
Time Frame
12 months
Title
Additional prostate cancer treatments
Description
Rate of additional treatment as decided by local practice, such as radical therapy (surgical removal of the prostate gland, radiation treatment to the prostate gland) or other intervention therapy to the ipsilateral and/or contralateral lobe, use of hormone or chemotherapies.
Time Frame
12 months
Title
Extension of prostate cancer
Description
Rate of reported extension of prostate cancer based on locally decided investigations (such as clinical examination, biopsy, Magnetic resonance Imaging (MRI), other).
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men over 18 years of age with a life expectancy ≥ 10 years
-.Unilateral adenocarcinoma of the prostate accurately located and confirmed as unilateral using high resolution biopsy strategies based on current best practice, such as multi- parametric MRI based strategies or template-based biopsy procedures.
Clinical stage T1c or T2a,
Gleason Score ≤ 6, based on high-resolution biopsy strategies
3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1 -2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
PSA ≤ 10 ng/mL
If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
Signed Informed Consent Form
Exclusion Criteria:
GENERAL EXCLUSION CRITERIA :
Unwillingness to accept the treatment;
Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
Participation in another clinical study involving an investigational product within 1 month before study entry;
Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
Subjects in custody and or residing in a nursing home or rehabilitation facility;
Biopsy proven locally advanced or metastatic prostate cancer.
SURGERY AND OTHER TREATMENT-RELATED CONDITIONS OF EXCLUSION
Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject or any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
Hypersensitivity to the active substance or to the excipient (mannitol)
Current or prior treatment for prostate cancer.
Patients who have been diagnosed with cholestasis.
Current exacerbation of rectal inflammatory bowel disease.
Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD. Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdel-Rahmène AZZOUZI, Professor
Organizational Affiliation
Centre Hospitalier Universitaire (CHU) ANGERS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire (CHU)
City
Angers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
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