Randomized phase II/III study of Risedronate in combination with Docetaxel versus Docetaxel alone in patients with hormone refractory prostate cancer.
Completed
- Registration Number
- NL-OMON22637
- Lead Sponsor
- ot applicable
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 480
Inclusion Criteria
1. Histologically proven prostate adenocarcinoma;
2. Hormone refractory;
Exclusion Criteria
1. Previous or concomitant use of biphosphonates;
2. Prior chemotherapy or radiotherapy within 4 weeks prior to treatment start;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of phase II part is to assess the objective PSA response to treatment by serial measurements of serum PSA as defined by the Bubley.<br><br>Primary objectives phase III study is to compare time to progression between concomitant and sequential use of docetaxel and risedronate, in combination with prednison.
- Secondary Outcome Measures
Name Time Method Secondary objectives phase II are to assess the toxicity profile, objective response (RECIST) and duration of PSA reponse.<br><br>Seondary objectives phase III study is to compare the following paramaters: PSA reponse (Nubley rate), PPI according to McGIll-Melzack toxicity profile, objective response (RECIST), duration of PSA response, survival