Phase II, randomized, multicentric study of docetaxel and zoledronic acid versus zoledronic acid in patient with prostate cancer and bone metastase treated with LHRH - ND
- Conditions
- Advanced prostate cancerMedDRA version: 9.1Level: HLTClassification code 10036966Term: Prostatic neoplasms and hypertrophy
- Registration Number
- EUCTR2008-002838-30-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
- Prostate adenocarcinoma
-Metastatic disease ab initio or neoplasic disease after loco-regional therapy
-Bone metastase
-Age > 18
-ECOG P.S-No previous chemotherapy
- Normal lab value
- Written informed consent
-
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
- Previous hormonal therapy except for less than 6 months treatment
-previous difosphonate treatment
-Concomitant serious disease (cardiovascular, hepathic, renal)
-Second neoplasia (except for skin basalioma)
-Peripheric neuropatia >/= 2
-brain metastases
-mental disorder
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression free survival;Secondary Objective: Survival, Tollerability, adverse event, quality of life, pain, scheletal related event, biological endpoint;Primary end point(s): Progression free survival
- Secondary Outcome Measures
Name Time Method