Metastatic Cancer, Pain, Prostate Cancer
Conditions
Keywords
stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Cancer Research UK
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United Kingdom
Outcome results
None listed