Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Metastatic Cancer, Pain, Prostate Cancer
About this trial
This is an interventional supportive care trial for Metastatic Cancer focused on measuring stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer
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
Sites / Locations
- William Harvey Hospital
- North Devon District Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Royal United Hospital
- Sussex Cancer Centre at Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- Queen's Hospital
- Kent and Canterbury Hospital
- Cumberland Infirmary
- Essex County Hospital
- Walsgrave Hospital
- Mayday University Hospital
- Russells Hall Hospital
- Eastbourne District General Hospital
- Royal Devon and Exeter Hospital
- Diana Princess of Wales Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Harrogate District Hospital
- Kidderminster Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Lincoln County Hospital
- Cancer Research UK and University College London Cancer Trials Centre
- Royal Marsden - London
- St. Mary's Hospital
- Charing Cross Hospital
- Clatterbridge Centre for Oncology
- Northampton General Hospital NHS Trust
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- King's Mills Hospital
- Nottingham City Hospital NHS Trust
- George Eliot Hospital
- Alexandra Healthcare NHS
- Oldchurch Hospital
- Conquest Hospital
- Scarborough General Hospital
- Scunthorpe General Hospital
- Royal Shrewsbury Hospital
- Southampton General Hospital
- Royal Marsden - Surrey
- Musgrove Park Hospital
- Torbay Hospital
- Warrington Hospital NHS Trust
- Warwick Hospital
- Sandwell General Hospital
- Weston General Hospital
- West Cumberland Hospital
- New Cross Hospital
- Worthing Hospital
- Yeovil District Hospital
- Cancer Care Centre at York Hospital
- Ninewells Hospital
- Glan Clwyd Hospital