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

Completed

• Conditions: Osteoporosis; Prostate Cancer

• Registration Number: NCT00176579
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-11
• Last Update Posted: 2011-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States