Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.

Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.

Inclusion criteria

• Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:

• Gleason 3+3 prostate
• Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
• Clinical stage up to cT2a - N0/Nx - M0/Mx.
• Serum prostate-specific antigen (PSA) ˂ 20ng/ml
• Prostate volume ≥ 25 cc and ≤ 70 cc.
• Male subjects aged 18 years or older.
• Signed Informed Consent Form by the patient.

Exclusion criteria

• Unwillingness to accept the treatment.
• Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
• Any surgical intervention for benign prostatic hypertrophy.
• Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
• Life expectancy less than 10 years.
• Participation in another clinical study involving an investigational product within 1 month before study entry.
• Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
• Subject in custody and or in residence in a nursing home or rehabilitation facility.
• Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
• Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
• Any history of urethral stricture disease;
• Any history of acute urinary retention within 6 months of study entry