Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance.

A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

The aims of this study are:

• to assess the impact of TOOKAD® Soluble-Vascular Targeted Photodynamic Therapy (VTP) on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A) and
• to determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD® Soluble-VTP compared to men on active surveillance (co-primary objective B).

This is a Phase 3, multicentre, open label, randomised controlled study in subjects diagnosed with low risk prostate cancer on TransRectal Ultrasound (TRUS) guided biopsy.

Subjects will be randomised to either Active Surveillance or TOOKAD® Soluble VTP. Subjects will remain in the study for approximately 24 months following randomisation. A total of 400 subjects will be entered into the study; 200 will receive Active Surveillance and 200 will receive TOOKAD® Soluble-VTP.

Inclusion Criteria:

Subjects will be eligible for inclusion in the study if all of the following criteria are met:

1. Low risk prostate cancer diagnosed using one transrectal ultrasound guided biopsy (TRUS)using from 10 to 24 cores performed less than 12 months prior to enrolment, and showing the following:

   • Gleason 3 + 3 prostate adenocarcinoma as a maximum,
   • Two (2) to three (3) cores positive for cancer
   • 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:

Subjects will not be eligible for the study if meeting any of the following criteria:

1. Unwillingness to accept randomisation 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.
8. Subject in custody and or in residence in a nursing home or rehabilitation facility
9. Contra-indication to Magnetic resonance Imaging (MRI) (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis)
10. Any condition or history of illness or surgery that may pose an additional risk to men undergoing the TOOKAD® Soluble VTP procedure.