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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT00975429 |
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Date of registration:
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10/09/2009 |
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Primary sponsor: |
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Public title:
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Study Using WST11 in Patients With Localized Prostate Cancer
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Scientific title:
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Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00975429 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Netherlands
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United Kingdom
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Contacts
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Name:
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Michel de Wildt, MD |
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Address:
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Email:
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Affiliation:
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Catharina Ziekenhuis |
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Name:
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Abdel-Rahmène AZZOUZI, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Unniversitaire Angers(CHU) |
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Name:
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Neil BARBER, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Frimley Park Hospital NHS Trust |
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Name:
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Arnauld VILLERS, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Claude Huriez |
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Name:
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Eric BARRET, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Mutualiste Montsouris (IMM) |
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Name:
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Gordon MUIR, MD |
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Address:
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Email:
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Affiliation:
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Kings College Hospital (KCH) |
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Name:
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Mark Emberton, Professor |
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Address:
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Affiliation:
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University College London Hospital (UCLH) |
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Key inclusion & exclusion criteria
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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 ULN, 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.).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: WST11
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Primary Outcome(s)
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Negative biopsy in the treated lobes
[Time Frame: Month 6]
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Secondary Outcome(s)
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Adverse events, ECG (12-lead),vital signs,clinical laboratory evaluations, physical examination.
[Time Frame: Screening-Month 6]
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Optimisation of the procedure
[Time Frame: Day 1]
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Quality of life IPSS; IIEF
[Time Frame: Month 1, Month 3 & Month 6]
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Serum PSA levels and PSA changes after treatment compared to baseline.
[Time Frame: Month 1, Month 3 & Month 6]
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Volume of hypoperfusion area shown by dynamic gadolinium MRI.
[Time Frame: Day 7, Month 6]
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Secondary ID(s)
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CLIN902 PCM203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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