Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer
Completed
- Conditions
- Prostate CancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN22844568
- Lead Sponsor
- Erasmus Medical Centre (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 480
Inclusion Criteria
1. Histologically proven prostate adenocarcinoma
2. Hormone refractory
3. Continued elevated PSA for at least 6 weeks after discontinuation of anti-androgens prior to registration; last PSA level >5 ng/ml
4. Stable analgesic regimen for at least one week prior to registration
5. Patients without surgical castration must continue on LHRH antagonists
6. Adequate bone marrow, liver, renal function
7. WHO 0-2
Exclusion Criteria
1. Previous or concomitant use of biphosphonates
2. Prior chemotherapy or radiotherapy within 4 weeks prior to treatment start
3. Uncontrolled hypercalcemia
4. Brain metastases
5. Previous or concomitant malignancies
6. Uncontrolled systemic disease of infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method