Prostate Cancer Clinical Trial
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
Summary
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
Full Description
OBJECTIVES:
Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
Compare markers of bone formation and resorption in patients treated with these regimens.
Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
Compare the survival rate of patients treated with these regimens.
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Stage III or IV disease
Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration
Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade
Continued concurrent androgen deprivation therapy required throughout study participation
No bone metastases by baseline bone scan
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
At least 1 year
Hematopoietic
Not specified
Hepatic
Bilirubin less than 3 times upper limit of normal (ULN)
AST and ALT less than 3 times ULN
No chronic liver disease
Renal
Creatinine no greater than 2.0 mg/dL
Other
Fertile patients must use effective contraception
No Paget's disease
No Cushing's disease
No hyperthyroidism
No hyperprolactinemia
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Prior chemotherapy for prostate cancer allowed
Endocrine therapy
See Disease Characteristics
More than 12 months since prior suppressive doses of thyroxine or calcitonin
More than 6 months since prior corticosteroids
Concurrent corticosteroids allowed (after enrollment on study)
Radiotherapy
Prior radiotherapy for prostate cancer allowed
Surgery
See Disease Characteristics
Other
More than 12 months since prior bisphosphonate therapy (oral or IV)
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There are 2 Locations for this study
Chicago Illinois, 60611, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
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