Osteoporosis, Prostate Cancer
Conditions
Keywords
osteoporosis, stage I prostate cancer
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 studying whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.
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 radical prostatectomy for cure are less likely to have an early relapse (i.e., less than 3 years) than those patients with a low level of BMD. OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort study. Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry with a densitometer. Posteroanterior measurements of the total hip are also recorded. Patients also undergo blood collection to examine markers that provide evidence of systemic disease. Patients are followed every 6 months for 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Interventions
PROCEDUREdual x-ray absorptiometry
Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
Sponsors
National Cancer Institute (NCI)
University of Medicine and Dentistry of New Jersey
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | Baseline | DXA scan will be done after patient signs consent and eligibilty is confirmed |
| Prostate Specific Antigen | Baseline, every 6 months for 3 years | PSA will be measured to look for biochemical recurrence of prostate cancer |
Countries
United States
Outcome results
None listed