Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.
Completed
- Conditions
- prostate cancer, metastases
- Registration Number
- NL-OMON20801
- Lead Sponsor
- Roche Nederland
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Karnofsky score „d60%;
2. Written informed consent;
Exclusion Criteria
1. Previous treatment with any kind of bisphosphonates or radionuclides;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective will be pain reduction on the pain scale (scale 0-10) at 12 weeks of treatment. Response of treatment will be defined as a reduction of at least two points of the pain scale.
- Secondary Outcome Measures
Name Time Method Pain reduction on the pain scale at 4-8-16-20-24 weeks of treatment. Use of analgesics at 4-8-12-16-20-24 weeks of treatment.<br /><br>New skeletal-related events (=time to progression, including fractures, need of repeated radiotherapy, surgery).<Br><br>Side effects at 4-8-12-16-20-24 weeks of treatment.<br /><br>Quality of Life, as measured by the EORTC-QLQ-C30 and EQ-5D, at 12-24 weeks.<br>