A randomised phase II/III study of Docetaxel plus Prednisolone vs. Docetaxel plus Prednisolone plus Zoledronic acid vs. Docetaxel plus Prednisolone plus Strontium-89 vs. Docetaxel plus Prednisolone plus Zoledronic Acid plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone. - TRAPEZE: phase II/III efficacy and safety clinical trial in Hormone Refractory Prostate Cancer
- Conditions
- Hormone refractory Prostate Cancer (HRPC)
- Registration Number
- EUCTR2004-002295-41-GB
- Lead Sponsor
- The University of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 757
1. Histologically / Cytologically proven prostate cancer or multiple sclerotic bone metastases with PSA>100ng/ml without histological confirmation.
2. Radiological evidence of bone metastasis
3. Documented disease progression
4. Life expectancy > 3 months
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
1. Prior cytotoxic chemotherapy for HRPC, other than estramustine monotherapy
2. Known brain or Leptomeningal metastases
3. Symptomatic peripheral neuropathy > grade 2 (NCI CTC)
4. Any condition, which, in the opinion of the investigator, might interfere with the safety of the patient or evaluation of study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method