prostate cancer, metastases
Conditions
Interventions
Ibandronaat tablet or placebo.
Sponsors
Roche Nederland
Eligibility
Inclusion criteria
Inclusion criteria: 1. Karnofsky score „d60%; 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 „d6 months; 6. Clinically documented painful bone metastases; 7. Indication for analgesic radiotherapy for the painful bone metastases.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any kind of bisphosphonates or radionuclides; 2. Hypercalcemia (serum calcium level >2.65 mmol/L), hypocalcemia (serum calcium level 266 umol/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. New skeletal-related events (=time to progression, including fractures, need of repeated radiotherapy, surgery). Side effects at 4-8-12-16-20-24 weeks of treatment. Quality of Life, as measured by the EORTC-QLQ-C30 and EQ-5D, at 12-24 weeks. | — |
Contacts
Public ContactL. Incrocci
Erasmus Medical Center, Daniel den Hoed Cancer Center, P.O. Box 5201
Outcome results
None listed