Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Clodronate in Patients with Locally Advanced Prostate Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | over 18 | MRC-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 Collaborators.University 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 PublicationsMason 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 Lead Organizations
Medical Research Council Clinical Trials Unit
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| Malcolm Mason, MD, Protocol chair | |
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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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