Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer|
- Bone mineral density [ Time Frame: Baseline ] [ Designated as safety issue: No ]DXA scan will be done after patient signs consent and eligibilty is confirmed
- Prostate Specific Antigen [ Time Frame: Baseline, every 6 months for 3 years ] [ Designated as safety issue: No ]PSA will be measured to look for biochemical recurrence of prostate cancer
|Study Start Date:||June 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Procedure: dual x-ray absorptiometry
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176579
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Stephen W. Marcella, MD, MPH||Rutgers Cancer Institute of New Jersey|