Hormone-refractory Prostate cancer first Line Intermittent Taxotere and Estramustine. - ND
- Conditions
- Prostate cancer.MedDRA version: 6.1Level: PTClassification code 10036909
- Registration Number
- EUCTR2006-005728-17-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 128
1 histologically proven diagnosis of prostate cancer 2 previous therapy with LHRH-analogue 3 PSA value rise during second line hormonal manipulation 4 performance status less than ECOG 2 5 life expectancy more than 12 weeks 6 adequate bone marrow function 7 written consent informed 8 patients ability to fill the quality of life questionnaire
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
1 disease progression without PSA rise 2 active infection 3 previous chemotherapy for prostate cancer 4 non adequate liver or renal functions 5 major diseases limiting chemotherapy 6 major cardiovascular diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1 evaluation of impact on patients quality of life of intermittent schedule 2 evaluation of efficacy of estramustine docetaxel association in terms of disease control;Secondary Objective: 1 evaluation of treatment tolerability 2 evaluation of quality of life parameters in relation to the treatments 3 evaluation of treatments activity in terms of disease burden 4 evaluation of treatments activity in terms of biochemical response 5 evaluation of overal survival and progression free survival 6 evaluation of duration of both biochemical response and clinical response 7 evaluation of treatments impact on pain;Primary end point(s): 1 percentual changes of GHS scale of EORTC QLQ-30 between relevations at randomization and after 12 months 2 absence of biochemical progression at 12 months after randomization
- Secondary Outcome Measures
Name Time Method