Phase III Randomized Double-Blind Study of Clodronate vs Placebo in Patients with Prostate Cancer Metastatic to Bone Who Are Commencing or Responding to Initial Hormone Therapy (Summary Last Modified 03/1999)
Clodronate Compared With Placebo in Treating Patients With Prostate Cancer Metastatic to Bone That Is Responding to Hormone Therapy
Basic Trial Information
|Phase III||Treatment||Closed||any age||MRC-PR05|
I. Compare the effect of clodronate vs. placebo for 3 years on time to development of symptomatic bone progression in patients with adenocarcinoma of the prostate with metastatic bone disease commencing or responding to initial hormone therapy. II. Measure and compare the incidence of subsequent treatment for bone metastases, symptomatic pathological or crush fractures, and spinal cord compression of patients on these 2 regimens. III. Compare the incidence of bone and nonbone progression and PSA and alkaline phosphatase levels of these patients. IV. Compare the analgesic consumption and performance status of these patients. V. Compare survival and toxicity in these patients.
Histologically diagnosed adenocarcinoma of the prostate TNM categories T2-4/Tx, N0-3/Nx Metastatic bone disease (M1b) documented on scan or skeletal radiographs Calcium normal (according to participating center) Commencing or clinically responding to initial hormone treatment, i.e.: Orchiectomy Luteinizing hormone-releasing hormone analogues Cyproterone acetate Complete androgen blockade
At least 12 months between other investigational drugs and first dose of study medication No previous hormone therapy No prior or concurrent bisphosphonates
Age: Any age Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 2 times normal Other: No acute, severe inflammatory gastrointestinal condition No serious concomitant physical or psychiatric disease No prior malignancy except nonmelanomatous skin cancer
300 patients will be entered over 2-3 years.
Randomized, double-blind, placebo-controlled study. Arm I: Single-Agent Chemotherapy. Clodronate. Arm II: Control. Placebo, PLCB.
Dearnaley DP, Sydes MR, Mason MD, et al.: A double-blind, placebo-controlled, randomized trial of oral sodium clodronate for metastatic prostate cancer (MRC PR05 Trial). J Natl Cancer Inst 95 (17): 1300-11, 2003.[PUBMED Abstract]
Dearnaley DP, Sydes MP: Preliminary evidence that oral bisphosphonate can delay symptomatic progression of bone metastases from prostate cancer: first results of the MRC PR05 trial. [Abstract] Br J Cancer 85 (suppl 1): A-CT4, 1, 2001.
Dearnaley DP, Sydes MR: Preliminary evidence that oral clodronate delays symptomatic progression of bone metastases from prostate cancer: first results of the MRC Pr05 trial. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-693, 2001.
Trial Contact Information
Trial Lead Organizations
Medical Research Council Clinical Trials Unit
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.