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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steba Biotech S.A.

Criteria

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