Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed prostate cancer
- Stage III or IV disease
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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
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Continued concurrent androgen deprivation therapy required throughout study participation
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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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
53 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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