Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer

Conditions
-----------------
Osteoporosis, Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: dual x-ray absorptiometry


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: dual x-ray absorptiometry|Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | DXA scan will be done after patient signs consent and eligibilty is confirmed | Baseline | 
| Prostate Specific Antigen | PSA will be measured to look for biochemical recurrence of prostate cancer | Baseline, every 6 months for 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, stage I prostate cancer