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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Southwest Oncology Group Eastern Cooperative Oncology Group National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079001 |
RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.
PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
Condition | Intervention | Phase |
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Metastatic Cancer Prostate Cancer |
Drug: placebo Drug: zoledronic acid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control |
Official Title: | A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone |
Estimated Enrollment: | 680 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive zoledronate IV over 15 minutes on day 1. Courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event.
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Drug: zoledronic acid
Given IV
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Arm II: Placebo Comparator
Patients receive placebo IV over 15 minutes on day 1. Courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event.
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Drug: placebo
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs ≥ ULN). Patients are randomized to 1 of 2 treatment arms.
Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or a skeletal-related event.
Patients are followed periodically for approximately 10 years after randomization.
PROJECTED ACCRUAL: A total of 680 patients (340 per treatment arm) will be accrued for this study within 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs
Concurrent androgen deprivation therapy required, defined as any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No more than 6 months since initiation of any of the following hormonal therapies:
Radiotherapy
Surgery
Other
Study Chair: | Matthew R. Smith, MD | Massachusetts General Hospital |
Study Chair: | Nirmala Bhoopalam, MD | Veterans Affairs Medical Center - Hines |
Study Chair: | Christopher Sweeney, MBBS | Indiana University Melvin and Bren Simon Cancer Center |
Study Chair: | Fred Saad, MD, FRCS | CHUM - Hotel Dieu Hospital |
Study ID Numbers: | CDR0000353209, CALGB-90202, ECOG-CALGB-90202, SWOG-CALGB-90202, CAN-NCIC-PRC2 |
Study First Received: | March 8, 2004 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00079001 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer bone metastases |
Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |