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

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