Status:
COMPLETED
Study Using WST11 in Patients With Localized Prostate Cancer
Lead Sponsor:
Steba Biotech S.A.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 (VT...
Detailed Description
This trial is designed as a multicentre, phase II, open-labeled, multi-arm, single intravenous (IV) dose study. The patient is to receive general anesthesia. WST11-mediated VTP will consist of the com...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00975429
Start Date
September 1 2009
End Date
August 1 2012
Last Update
April 28 2015
Active Locations (7)
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1
Centre Hospitalier Universitaire (CHU)
Angers, France
2
Hôpital Claude Huriez
Lille, France
3
Institut Mutualiste Montsouris(IMM)
Paris, France
4
Catharina Ziekenhuis
Eindhoven, Netherlands