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

NCT ID: NCT00176579

Last Updated: 2011-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2008-07-31

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.

Conditions

Osteoporosis; Prostate Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

dual x-ray absorptiometry

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

UMDNJ/CINJ

Principal Investigators

Stephen W. Marcella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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

New Brunswick, New Jersey, United States

Countries

United States

Related Links

http://clinicaltrials.gov/ct2/show/NCT00176579

Clinical trial summary from Clinicaltrials.gov website

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CINJ-5004

Identifier Type: -

Identifier Source: secondary_id

CINJ-4375

Identifier Type: -

Identifier Source: secondary_id

CDR0000539677

Identifier Type: -

Identifier Source: org_study_id