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Clinical Trials (PDQ®)

Phase III Randomized Study of Clodronate for Locally Advanced Adenocarcinoma of the Prostate

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

Alternate Title

Clodronate in Patients with Locally Advanced Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedover 18MRC-PR04
EU-94032

Objectives

I.  Compare the time to symptomatic bone metastases in patients with locally 
advanced adenocarcinoma of the prostate treated with clodronate vs. placebo 
for 5 years.

II.  Measure and compare the incidence of subsequent treatment for symptomatic 
bone metastases, symptomatic pathologic or crush fractures, and spinal cord 
compression of patients on these 2 arms.

III.  Compare the incidence of predominantly bone, bone and any other site, 
predominantly nonosseous, and local disease progression on these 2 arms.

IV.  Compare survival and toxicity in these patients.

Entry Criteria

Disease Characteristics:


Histologically diagnosed adenocarcinoma of the prostate
  TNM categories T2-4, N0-3, or NX, M0
  Initial diagnosis within the past 3 years

No bone metastases on scan
  Calcium normal (according to participating center)

No nodal disease outside the pelvis


Prior/Concurrent Therapy:


Prior or concurrent standard treatment including radiotherapy, surgery,
androgen deprivation, or observation for localized disease allowed
  Patients entered on MRC-PR06 study of prostatectomy, radiotherapy and no
  immediate treatment in early prostate cancer are eligible

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

No prior or concurrent bisphosphonates


Patient Characteristics:


Age:
  Over 18

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 other active malignancy within 5 years

Pretreatment studies required within 4 weeks prior to randomization


Expected Enrollment

500 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

Mason MD, Sydes MR, Glaholm J, et al.: Oral sodium clodronate for nonmetastatic prostate cancer--results of a randomized double-blind placebo-controlled trial: Medical Research Council PR04 (ISRCTN61384873). J Natl Cancer Inst 99 (10): 765-76, 2007.[PUBMED Abstract]

Mason MD; MRC PR04 CollaboratorsUniversity of Wales College of Medicine: Development of bone metastases from prostate cancer: first results of the MRC PR04 trial (ISCRTN 61384873). [Abstract] J Clin Oncol 22 (Suppl 14): A-4511, 384s, 2004.

Related Publications

Mason MD, Glaholm J, Dearnaley DP: The use of bisphosphonates in prostatic cancer. Clin Oncol (R Coll Radiol) 6 (2): 77-8, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Malcolm Mason, MD, Protocol chair
Ph: 44-29-2031-6964
Email: masonmd@cardiff.ac.uk

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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