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

August 11, 2011 updated by: University of Medicine and Dentistry of New Jersey

Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: dual x-ray absorptiometry

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Subjects will be recruited from urologists' offices and the oncological practices of CINJ. This will be done by verbal communication through the office staff and with the distribution of a brochure briefly describing the study. If a person is interested, he will be given information that briefly describes the study and his name will be taken down. A research assistant will call him and set up a meeting, preferably at the same time he is scheduled to see his physician. At that meeting, a research assistant will go over the consent form with him and cover all questions concerning the study. Eligibility (based on history) will also be verified at this meeting. If he wishes to participate, he will be instructed to sign the consent and an appointment for the blood tests and DXA scan will be arranged.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Stephen W. Marcella, MD, MPH, Rutgers Cancer Institute of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical trial summary from Clinicaltrials.gov website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria