Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Men over 18 years of age;
Diagnosed with prostate cancer and eligible for active surveillance;
No prior treatment for prostate cancer;
Prostate Cancer Stage up to cT2b - N0/Nx - M0/Mx (rT2c and pT2c are acceptable)
Gleason score ≤ 3+3 For patients characterized with prostate mapping (transperineal template guided biopsy at 5mm intervals) a secondary pattern 4 is acceptable provided that it is not present in more than 3 cores from each side of the prostate and is no more than 3 mm cancer core length.
PSA < 10 ng/mL;
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;
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
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,). 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);
Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).