Multidisciplinar, multicenter, randomized phase III clinical trial comparing taxotere plus estramustine phosphate plus prednisone, versus taxotere prednisone, in advanced prostate carcinoma patients with biochemical relapse during androgen ablation.
- Conditions
- Acvanced prostate carcinoma
- Registration Number
- EUCTR2004-003885-14-ES
- Lead Sponsor
- Aventis Pharma, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 172
- Histologically confirmed prostate adenocarcinoma
- Confirmed prostate adenocarcinoma in biochemistry progression androgens block and demonstrated progression despite cessation of antiandrogen therapy.
- Patients must have received prior hormonal therapy.
- Castration levels of testosterone (Minor to 50 ng/dL)
- Biochemistry relapse.
- Adequate bone marrow, Hepatic and Renal function.
- Patients must be accessible for treatment and follow-up.
- Prior surgery and/or radiation therapy is allowed if at least 4 weeks have elapsed since the completion of radiation therapy and the patient have recovered from side effects.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range
- Prior cytotoxic chemotherapy (including AMP, Ketoconazole), radio isotopes or other hormonal therapy.
- Prior malignancy except any cancer adequately treated from wich the patient has been disease free for 2 years or more.
- Symptomatic peripheral neuropathy grade mayor or equal to 2 according to NCIC-CTG criteria.
- Concomitant serious illness or medical condition:
a) Uncontrolled or severe cardiovascular disease.
b) Active uncontrolled infection.
c) Active peptic ulcer.
d) Unstable diabetes mellitus.
- Previous history of tromboembolic events in the last 6 months or active thrombophlebitis.
- Medical contraindication for EMP including history to estradiol or nitrogen mustard.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: PSA response rates (PSAWG criteria);Secondary Objective: - Time to Treatment Failure<br>- Progression Free Survival (either biochemical or clinical)<br>- Overall and Cause Specific Survival<br>- Clinical response rates (RECIST)<br>- Safety. Toxicity profile according to NCIC-CTG Criteria<br>- Quality of Life (EORTC QLC-30Q+ prostate questionnaire);Primary end point(s): PSA response rates (PSAWG criteria
- Secondary Outcome Measures
Name Time Method