Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients

Conditions
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Osteoporosis, Prostate Cancer

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer