Localized prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Sponsors
STEBA BIOTECH SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men over 18 years of age; 2. Diagnosed with prostate cancer and eligible for active surveillance; 3. No prior treatment for prostate cancer; 4. Prostate Cancer Stage up to cT2b – N0/Nx – M0/Mx (rT2c and pT2c are acceptable); 5. 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. 6. PSA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. All patients whose current pre-operative cardiac evaluation does not show their fitness for a procedure requiring general anesthesia; 3. 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; 4. Patients with a history of inflammatory bowel disease or other factors which may increase the risk of fistula formation; 5. Men who have received any hormonal manipulation (excluding 5-alpha reductase inhibitors) or androgen supplements within the previous 6 months; 6. Men previously treated by radiation therapy (external therapy or brachytherapy) or chemotherapy or any therapy for prostate cancer; 7. Men who have received or are receiving chemotherapy for prostate carcinoma or other significant cancer; 8. Men who have undergone previous TURP (trans-urethral resection of the prostate); 9. Men who are currently receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin). 10. Men who are receiving anticoagulant drugs (e.g.: coumadin, warfarin). 11. .Patient who stopped long term treatment of acetylsalicylic acid (aspirin) or other anti platelets agents less than 15 days before the procedure; 12. Patient suspected of Disseminated Intravascular Coagulation (DIC) as defined by the presence of three out of the five following criteria: platelets ULN, PT>ULN, aPTT >ULN, fibrinogenULN 13. History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires; 14. Participation in a clinical study or receipt of an investigational treatment within the past 3 months; 15. A history of porphyria; 16. A history of sun hypersensitivity or photosensitive dermatitis; 17. Renal disorders (blood creatinine > 1.5 x ULN) or known post mictional residue > 150cc 18. 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; 19. Hematological disorders (white cells < 2500/mm3, neutrophils < 1500/mm3, platelets < 140.000/mm3, Hb < 8 g/dL); 20. Patient with contra-indication to MRI (such as pace maker, metal prosthesis, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer with both normal (<60cc) and high-volume prostates (=60cc). ;Secondary Objective: - To evaluate the safety and quality of life following WST11 VTP treatment in patients with localized prostate cancer and both normal (<60cc)- and high-volume prostates (=60cc). - To assess the effects of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP treatment in patients with both normal (<60cc) and high-volume prostates (=60cc). - To evaluate the safety and quality of life following a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP treatment in patients with both normal (<60cc) and high-volume prostates (=60cc). - To explore optimisation techniques to reduce the duration of the VTP procedure;Primary end point(s): The result of the Month 6 12-core prostate biopsy will give the primary efficacy criterion of this study. The success of the treatment for a patient is defined by negative biopsy in the treated lobes that initially contained the tumor(s). | — |
Countries
France, Netherlands, United Kingdom
Outcome results
None listed