Status:
COMPLETED
Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Osteoporosis
Prostate Cancer
Eligibility:
MALE
50-75 years
Brief Summary
RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer will come back. It may also help the study of prostate cancer in the future. PURPOSE: This clinical trial is...
Detailed Description
OBJECTIVES: * Determine bone mineral density (BMD) in patients with clinically significant early stage prostate cancer. * Determine whether patients who have a higher level of BMD and have had a radi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-confirmed early stage prostate cancer
- Disease localized within the capsule
- No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease)
- A cohort of patients must have undergone a prior radical prostatectomy
- Prostate specific antigen \< 12 ng/mL
- Gleason score ≥ 6
- PATIENT CHARACTERISTICS:
- Creatinine clearance ≤ 2.0 mg/dL
- No Paget's disease
- No hyperthyroidism or hypothyroidism
- No Cushing's disease
- No chronic liver disease
- No major health problems that would cause a significant reduction in mobility or activities of daily living
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior bisphosphonates, thyroxin, or calcitonin
- No prior agents that suppress PSA levels (e.g., finasteride)
- No prior androgen or estrogen therapy
- More than 12 months since prior glucocorticoids
- More than 12 months since prior herbal supplements that are known to lower PSA levels
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00176579
Start Date
June 1 2003
End Date
July 1 2008
Last Update
August 12 2011
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903