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

University of Medicine and Dentistry of New Jersey27 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoporosis Prostate Cancer

Interventions

dual x-ray absorptiometryPROCEDURE

Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Bone mineral density

DXA scan will be done after patient signs consent and eligibilty is confirmed

Time frame: Baseline

Prostate Specific Antigen

PSA will be measured to look for biochemical recurrence of prostate cancer

Time frame: Baseline, every 6 months for 3 years

Data from ClinicalTrials.gov

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