Newark, New Jersey 07101


Purpose:

This research study is being done to find out if giving zoledronic acid before the cancer spreads to the bone is better or worse than standard treatment. The study will also compare the effects (good and bad) of early treatment with zoledronic acid compared to standard treatment. In this study Group A will receive zoledronic acid and Group B will receive placebo (salt and water). The placebo contains no medication and is used to compare the effects of early treatment with zoledronic acid to no early treatment with zoledronic acid in a fair way. It is used so that neither you nor your doctor will know what you are receiving.


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


NCT ID:

NCT00698308


Primary Contact:

Study Chair
Matthew Smith, MD, PhD
Massachusetts General Hospital

Lillian Pliner, MD
Phone: 9739726257
Email: plinerlf@umdnj.edu


Backup Contact:

Email: barberys@umdnj.edu
Yasmeen S Barber, BA
Phone: 9739727789


Location Contact:

Newark, New Jersey 07101
United States

Yasmeen S Barber, BA
Phone: 973-972-7789
Email: barberys@umdnj.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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