Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer
- Conditions
- Prostate CancerCancerProstate
- Registration Number
- ISRCTN55471205
- Lead Sponsor
- Erasmus Medical Center (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1. Karnofsky score >60%
2. Written informed consent
3. Histologically proven PC with documented (bone scintigraphy, CT scan, MRI, or conventional X-Ray) bone metastases, without spinal cord/cauda equina compression
4. Indication for analgesic radiotherapy
5. Estimated life expectancy of >6 months
6. Clinically documented painful bone metastases
7. Indication for analgesic radiotherapy for the painful bone metastases
1. Previous treatment with any kind of bisphosphonates or radionuclides
2. Hypercalcemia (serum calcium level >2.65 mmol/l), hypocalcemia (serum calcium level <2.2 mmol/l), impaired renal function (creatinine >266 µmol/l; albumin >50 g/l), according to the medical charts
3. Investigational drugs within 30 days before study entry
4. Paget's disease
5. Untreated esophagitis or gastric ulcer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method