Vascular-targeted photodynamic therapy using WST11 in patients with localised prostate cancer

• Conditions: Prostate cancer; MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2008-000876-26-NL
• Lead Sponsor: STEBA BIOTECH N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

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 < 10 ng/mL;
7. Signed Informed Consent Form.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (within the month before the treatment procedure) receiving any medications having potential photosensitizing effects (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin);
10. Men who are currently 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 decrease, increase of PT, increase of aPTT, fibrinogen decrease, D-Dimer increase.
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, 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;
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.).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified