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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases Clinical research trials and Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "Z" Clinical Trials Conditions > Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases  Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
For Condition: bone metastases,stage 4 prostate cancer,recurrent prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of zoledronate in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
Details: 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 incidence of vertebral fractures at 2 years 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 for at least 3 years. PROJECTED ACCRUAL: A total of 680 patients (340 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 3.0 mg/dL - 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 1 year before study entry - No more than 3 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 standard marketed antineoplastic therapies allowed during open-label therapy only
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MatthewSmith, Study Chair, Massachusetts General Hospital
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Additional Information:
Study ID Numbers: CDR0000353209; CALGB-90202
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079001
Other Stage 4 Prostate Cancer Studies:
1. Biological Therapy in Treating Patients With Prostate Cancer
2. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
3. Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
4. Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
5. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
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