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Clinical Trials (PDQ®)

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)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Clodronate Compared With Placebo in Treating Patients With Prostate Cancer Metastatic to Bone That Is Responding to Hormone Therapy

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageMRC-PR05
EU-94033

Objectives

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.

Entry Criteria

Disease Characteristics:


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


Prior/Concurrent Therapy:


At least 12 months between other investigational drugs and first dose of study
medication

No previous hormone therapy

No prior or concurrent bisphosphonates


Patient Characteristics:


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


Expected Enrollment

300 patients will be entered over 2-3 years.

Outline

Randomized, double-blind, placebo-controlled study.

Arm I:  Single-Agent Chemotherapy.  Clodronate.

Arm II:  Control.  Placebo, PLCB.

Published Results

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

David P. Dearnaley, MD, FRCP, FRCR, Protocol chair
Ph: 44-20-8661-3271

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.

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