Prostate Cancer Clinical Trial
Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Summary
RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably.
PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.
Full Description
OBJECTIVES:
Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer.
OUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no).
Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan.
A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Stratum 1 (androgen ablation therapy):
Bone metastases
Prior orchiectomy allowed
Prior or concurrent leuprolide and/or goserelin therapy allowed
Stratum 2 (androgen ablation therapy):
No bone metastases
Prior orchiectomy allowed
Prior or concurrent leuprolide and/or goserelin therapy allowed
Stratum 3 (no androgen ablation therapy):
No metastatic disease
Prior flutamide or bicalutamide therapy allowed
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Calcium normal
Hepatic:
Not specified
Renal:
Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
See Disease Characteristics
Endocrine therapy:
See Disease Characteristics
No concurrent high dose steroids
Radiotherapy:
Prior radiotherapy allowed
Surgery:
See Disease Characteristics
Prior radical prostatectomy allowed
Other:
No concurrent bisphosphonates
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There is 1 Location for this study
Rochester New York, 14642, United States
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