Study of WST11 in Patients With Localized Prostate Cancer

Exclusion Criteria

• •Any condition or history of illness or surgery that, in the opinion of the investigator and/or the Sponsor, might confound the results of the study or pose additional risks to the patient.
• •Patients with a prior history of viral or alcoholic hepatitis, and other patients felt to be at risk for hepatotoxicity including concomitant use of potentially hepatotoxic medications or dietary supplements;
• •History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires;
• •Participation in a clinical study or receipt of an investigational treatment within the past 3 months;
• •A history of porphyria;
• •Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.);
• •All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
• •Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
• •Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
• •Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
• •Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
• •Men who have undergone previous TURP (trans-urethral resection of the prostate);
• •Men who are currently receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin);
• •Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin)
• •Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure;
• •Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets \<LLN, PT \>ULN,aPTT \>ULN, fibrinogen\<LLN, D-Dimer \>ULN;
• •A history of sun hypersensitivity or photosensitive dermatitis;
• •Renal disorders (blood creatinine \> 1.5 x ULN) or known post mictional residue \> 150cc;
• •Hepatic disorders (transaminases \> ULN, bilirubin \> ULN). In case of slight abnormalities, another exam should be performed. If the results are within normal ranges, then the patient can be included;
• •Hematological disorders (white cells \< 2500/mm3, neutrophils \< 1500/mm3, platelets \< 140.000/mm3, Hb \< 8 g/dl);