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Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases - NCT00079001-87110(Clinical Trial 119729)



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City:  Albuquerque
State:  
NM
Zip Code: 87110
Conditions: Metastatic Cancer - Prostate Cancer
Purpose: 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.
Study summary: OBJECTIVES: Primary - Compare the time to first skeletal-related events in patients with prostate cancer and bone metastases undergoing androgen deprivation therapy when treated with zoledronate vs placebo. Secondary - Compare the overall and progression-free survival of patients treated with these regimens. - Compare the toxic effects in patients treated with these regimens. 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. - Arm I: Patients receive zoledronate IV over 15 minutes on day 1. - Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, courses repeat every 4 weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily. 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.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - No small cell, neuroendocrine, or transitional cell carcinomas - At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs - Indeterminate lesions should be confirmed by a second imaging method - At least 1 bone metastasis with no prior irradiation - Concurrent androgen deprivation therapy required, defined as any of the following: - Bilateral orchiectomy - Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine clearance ≥ 30 mL/min - Corrected calcium ≥ 8.0 mg/dL and < 11.6 mg/dL Other - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Concurrent standard biologic response modifiers allowed during open-label therapy only Chemotherapy - Concurrent standard cytotoxic chemotherapy allowed during open-label therapy only Endocrine therapy - See Disease Characteristics - Prior neoadjuvant and/or adjuvant hormonal therapy allowed provided duration of therapy was no more than 6 months AND therapy was discontinued more than 6 months before study entry - No more than 6 months since initiation of any of the following hormonal therapies: - Orchiectomy - GnRH agonist (e.g., leuprolide, goserelin, or triptorelin) - Estrogen therapy - Antiandrogens (e.g., bicalutamide, flutamide, or nilutamide) - Any other therapy known to lower testosterone levels or inhibit testosterone effect - No intermittent androgen deprivation therapy except for patients concurrently enrolled on SWOG-9346 - Concurrent palliative corticosteroids allowed during open-label therapy only - Concurrent standard hormonal agents allowed during open-label therapy only Radiotherapy - See Disease Characteristics - No prior radiopharmaceuticals - At least 4 weeks since prior radiotherapy - Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed during open-label therapy only Surgery - See Disease Characteristics Other - No prior bisphosphonates - No other concurrent agents expected to alter osteoclast activity (e.g., calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate) - Concurrent daily supplemental elemental calcium (500 mg) and a multivitamin containing cholecalciferol (Vitamin D) (400 IU) OR a combination tablet containing both recommended - Concurrent standard marketed antineoplastic therapies allowed during open-label therapy only
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Data Source: ClinicalTrials.gov
Date Processed: March 15, 2010
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