single-dose local radiation therapy compared with ibandronate in treating patients with localized metastatic bone pain

Conditions: Metastatic Cancer; Pain; Prostate Cancer

Summary: rationale: ibandronate may be effective in reducing bone pain caused by metastatic cancer. radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain. purpose: this phase iii randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.

objectives: primary * compare pain response at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy . secondary * compare the quality of life of patients treated with these regimens. * correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens. outline: this is a randomized, open-label, crossover, multicenter study. patients are stratified according to primary tumor type and participating center. patients are randomized into 1 of 2 treatment arms. * arm i: patients receive a single dose of local radiotherapy to the site of pain (8gy/1f). * arm ii: patients receive a single dose of ibandronate iv over 15 minutes. patients who do not achieve a partial or complete response at 4 weeks crossover to the alternate arm. quality of life is assessed at baseline and then at 4 and 12 weeks. pain is assessed at baseline, at 4, 8, and 12 weeks, and then at 6 months. patients are followed at 4, 8, and 12 weeks and then at 6 and 12 months. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 470 patients (235 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed primary prostate cancer or sclerotic bone metastases (for patients with serum prostate-specific antigen \> 100 ng/ml) * radiologically confirmed bone metastases by plain x-ray, isotope scan, ct scan, or mri * clinical diagnosis of metastatic bone pain for which radiotherapy is indicated * single localized metastatic bone pain and receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated * hormone receptor status: * not specified patient characteristics: age * over 18 sex * male menopausal status * not specified performance status * not specified life expectancy * at least 3 months hematopoietic * not specified hepatic * not specified renal * creatinine ≤ 3.0 mg/dl * no hypercalcemia (corrected calcium \> 10.8 mg/dl) * no hypocalcemia (corrected calcium \< 8.2 mg/dl) other * no known hypersensitivity to ibandronate or other bisphosphonates * no history of aspirin-sensitive asthma * able to comply with pain chart and quality of life assessments prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 4 weeks since prior change in systemic chemotherapy * no prior high-dose chemotherapy (dose intensity \> 3 times standard dose) endocrine therapy * more than 4 weeks since prior change in hormonal therapy radiotherapy * see disease characteristics * no prior external beam radiotherapy to index site * no prior systemic radioisotope therapy (e.g., strontium chloride sr 89 or samarium sm 153 lexidronam pentasodium) surgery * not specified other * more than 6 months since prior bisphosphonate treatment * more than 4 weeks since prior aminoglycoside antibiotics * more than 30 days since prior investigational drugs

Keywords: stage iv prostate cancer bone metastases pain recurrent prostate cancer