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Sponsors and Collaborators: |
James P. Wilmot Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003903 |
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.
Condition | Intervention |
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Osteoporosis Prostate Cancer |
Procedure: management of therapy complications |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients |
Estimated Enrollment: | 150 |
Study Start Date: | July 1999 |
OBJECTIVES:
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stratum 1 (androgen ablation therapy):
Stratum 2 (androgen ablation therapy):
Stratum 3 (no androgen ablation therapy):
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
James P. Wilmot Cancer Center | |
Rochester, New York, United States, 14642-0001 |
Study Chair: | Deepak M. Sahasrabudhe, MD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000067078, URCC-U2898, NCI-G99-1522 |
Study First Received: | November 1, 1999 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00003903 History of Changes |
Health Authority: | United States: Federal Government |
stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer osteoporosis |
Prostatic Diseases Genital Neoplasms, Male Musculoskeletal Diseases Bone Resorption Neoplasm Metastasis Osteoporosis |
Urogenital Neoplasms Bone Diseases, Metabolic Genital Diseases, Male Bone Diseases Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Musculoskeletal Diseases Osteoporosis |
Urogenital Neoplasms Bone Diseases, Metabolic Genital Diseases, Male Bone Diseases Prostatic Neoplasms |