Study Using WST11 in Patients With Localized Prostate Cancer

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.

The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steba Biotech S.A.

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: plateletsULN, aPTT >ULN, fibrinogenULN

• 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.).