An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
N/A
N/A
Male
Osteoporosis, Prostate Cancer
Trial Information
An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Deepak M. Sahasrabudhe, MD
Investigator Role:
Study Chair
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067078
NCT ID:
NCT00003903
Start Date:
July 1999
Completion Date:
Related Keywords:
- Osteoporosis
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- osteoporosis
- Osteoporosis
- Prostatic Neoplasms
Name | Location |
|---|---|
| James P. Wilmot Cancer Center | Rochester, New York 14642 |
