Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer

Inclusion Criteria:

• At least 18 years of age
• Diagnosed with localized, prostate cancer and who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; EBRT), and refused
• Localized prostate cancer stage T1C up to T2A based on biopsy performed at least 6 weeks prior to enrollment
• Gleason score ≤ 3+3 with ≤50% of sampled cores positive, and each positive core having a tumour length of ≤5 mm
• PSA < 10 ng/mL
• No prior treatment for prostate cancer
• Signed Informed Consent Form

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.
• All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia;
• 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;
• Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation;
• Patients who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months;
• Patients previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer;
• Patients who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer;
• Patients who have undergone previous TURP (trans-urethral resection of the prostate);
• Patients with a history of urethral stricture disease
• Patients with a history of acute urinary retention
• Patients who are currently (within 10 days before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
• Patients who are currently receiving anticoagulant drugs (within 10 days before the treatment procedure) (e.g.: coumadin, warfarin)
• Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents within 10 days prior to the treatment procedure;
• Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase; from the normal laboratory ranges;
• Patient with a history of vasculitis or collagen vascular disease;
• 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;
• 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, GGT > ULN). In case of slight abnormalities, another exam could 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 ≤ 10 g/dL);
• Patients with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).