A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined (TRAPEZE)

niversity of Birmingham (UK)0 个研究点目标入组 618 人开始时间: 2005年9月8日最近更新: 2022年4月4日

适应症

试验速览

•1. Age >18 years
•2. Histologically/cytologically proven prostate cancer or multiple sclerotic bone metastases with prostate specific antigen (PSA) >100 ng/ml without histological confirmation
•3. Radiological evidence of bone metastatsis
•4. Prior hormonal therapy for prostate cancer, resulting in serum testosterone <50 ng/dl: bilateral orchidectomy, and/or medical castration by LHRH agonist therapy
•5. Documented disease progression, defined by one of the following: elevated PSA (progressive rise) and/or progression of any unidemensionally or bidimensionally measurable malignant lesion at least one new lesion identified on bone scan
•7. Life expectancy >3 months
•8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•9. Adequate haematological function
•10. Adequate renal and hepatic function
•11. Written Informed Consent

•1. Prior cytotoxic chemotherapy for HRPC, other than estramustine monotherapy
•2. Prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation
•3. Prior radionuclide therapy for HRPC
•4. Prior tretament with a bisphosphonate for any reason within previous 2 months
•5. Malignant disease within the previous 5 years, other than adequatly treated basal cell carcinoma
•6. Known brain or leptomeningeal metastases
•7. Symptomatic peripheral neuropathy >grade 2 (NCI CTC)
•8. Known hypersensitivity to bisphosphonates
•9. Concurrent enrolment in any other investigational clinical trial
•10. Treatment with any other investigational compound within previous 30 days
•11. Any condition, which, in the opion of the investigator, might interfere with the safety or evaluation of the study objectives

发起方

niversity of Birmingham (UK)