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

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

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

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

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):

  1. 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.

  2. Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted).

  3. Serum prostate specific antigen (PSA) of 10 ng/mL or less.

  4. Prostate volume equal or greater than 25 cc and less than 70 cc.

  5. 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):

  1. Unwillingness to accept randomization to either of the two arms of the study.
  2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy.
  3. Any surgical intervention for benign prostatic hypertrophy.
  4. Life expectancy less than 10 years.
  5. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
  6. Participation in another clinical study or recipient of an investigational product within 1 month of study entry.
  7. 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.
  8. 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).