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

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