Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
NCT ID: NCT00003903
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
1999-07-31
2007-08-31
Brief Summary
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PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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management of therapy complications
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Principal Investigators
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Deepak M. Sahasrabudhe, MD
Role: STUDY_CHAIR
James P. Wilmot Cancer Center
Locations
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James P. Wilmot Cancer Center
Rochester, New York, United States
Countries
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Other Identifiers
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URCC-U2898
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1522
Identifier Type: -
Identifier Source: secondary_id
CDR0000067078
Identifier Type: -
Identifier Source: org_study_id
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