European Randomised Study of TOOKAD® Soluble for Prostate Cancer vs Active Surveillance. Post Study Follow-up

Study Overview
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Brief Summary
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This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

Detailed Description
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This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). No intervention or further intervention with TOOKAD® Soluble is mandated in this additional 60-month follow-up study where patients in the original TOOKAD® Soluble group and active surveillance (control) group are both managed by their physician as appropriate to their condition using any treatment available following a 'local standard of care' principle from the end of the trial (M24) up to the end of follow-up (M84). Management decisions are entirely left to clinicians and their patients in this pragmatic extension of the trial (no criteria imposed) where standard of care that reflects clinical practice within each centre is applied. All patients originally randomised in study CLIN1001 PCM301, whether allocated to the TOOKAD® Soluble VTP arm (n=206) or Active surveillance arm (n=207 and who did not withdraw their consent will be included in this extension study. This extension study consists of 2 different follow-up: a follow-up of patients via investigators and a follow-up via interviews directly with patients

Official Title
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A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up

Conditions
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Cancer of the Prostate

Intervention / Treatment
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* Other: no intervention (post study follow up)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects originally randomized in study CLIN1001 PCM301 are included in this follow-up study. As a reminder, they all met the following criteria at entry (from the original protocol): Low risk prostate cancer diagnosed using one trans-rectal ultrasound guided biopsy (TRUS) using from 10 to 24 cores, within 12 months of enrolment and showing the following: Gleason 3 + 3 prostate adenocarcinoma as a maximum, Two (2) to three (3) cores positive for cancer. Patients with only one positive core can be included provided they have at least 3 mm of cancer core length. A maximum cancer core length of 5 mm in any core. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted). Serum prostate specific antigen (PSA) of 10 ng/mL or less. Prostate volume equal or greater than 25 cc and less than 70 cc. Male subjects aged 18 years or older. Exclusion Criteria: As a reminder, all subjects originally randomized did not met the following criteria at entry (from the original protocol): Unwillingness to accept randomization to either of the two arms of the study. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy. Any surgical intervention for benign prostatic hypertrophy. Life expectancy less than 10 years. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. Participation in another clinical study or recipient of an investigational product within 1 month of study entry. Subject unable to understand the patient's information document, to give consent or complete the study tasks. Subject in custody and or in residence in a nursing home or rehabilitation facility. Contra-indication to MRI (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TOOKAD VTP TREATMENT<br>Subjects randomized in the treatment arm (TOOKAD VTP treatment) in the initial period of the study. | Other: no intervention (post study follow up)<br>* No intervention (post study follow up)<br>|
| Active surveillance<br>Subjects randomized in the control group (active surveillance) in the initial period of the study. | Other: no intervention (post study follow up)<br>* No intervention (post study follow up)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men initially randomized to TOOKAD® Soluble VTP compared to men originally randomized on active surveillance. | Over the 5 years of follow up | 
| Other prostate cancer therapy | Use of other prostate cancer therapy: radical therapy (surgery, radiotherapy, cryotherapy, ultrasound therapy), hormonal therapy or chemotherapy or any therapy indicated for the treatment of prostate cancer in the countries of the study. | Over the 5 years of follow up | 
| Prostate cancer-related death. | Any death related to Prostate cancer | Over the 5 years of follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of cancer | The proportion of absence of cancer at biopsy (when available) | Over the 5 years of follow up | 
| Radical therapy | The rate of prostate cancer radical therapy; | Over the 5 years of follow up | 
| Cancer burden | The total cancer burden in the prostate | Over the 5 years of follow up | 
| Urinary incontinence | The description of incontinence in terms of mean, median, SD, inter-quartile ranges, min-max | Over the 5 years of follow up | 
| Erectile dysfunction | The description of erectile dysfunction in terms of mean, median, SD, inter-quartile ranges, min-max | Over the 5 years of follow up | 
| Urethral stenosis | The rate of urethral stenosis | Over the 5 years of follow up | 
| Prostate cancer complication | The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death | Over the 5 years of follow up | 
| Patients Questionnaires Quality of life | Overal Quality of Life will be recorded for potential utility and descriptives studies | Over the 5 years of follow up |