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



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

For Condition: stage 4 prostate cancer,Osteoporosis,stage 2 prostate cancer,stage 1 prostate cancer,stage 3 prostate cancer
Status: No longer recruiting
Sponsor(s): James P. Wilmot Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DeepakSahasrabudhe,  Study Chair,  James P. Wilmot Cancer Center

James P. Wilmot Cancer Center
Rochester,  New York,  14642-0001
United States
 


Additional Information:
Study ID Numbers:  CDR0000067078;  URCC-U2898,NCI-G99-1522
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003903

Other Stage 4 Prostate Cancer Studies:
1. Hormone Replacement in Young Women with Premature Ovarian Failure

2. Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major

3. Determining the risk factors such as smoking, alcohol, and caffeine and their association with osteoporosis in men.

4. A School-Based Osteoporosis Prevention Program for Adolescent Girls

5. Building Better Bones in Children

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