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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 10, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bone mineral density
Recurrence

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00176579 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Osteoporosis
Prostate Cancer

Intervention ^ICMJE

Other: laboratory biomarker analysis
Procedure: dual x-ray absorptometry
Procedure: evaluation of cancer risk factors

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00176579

Responsible Party

Stephen Marcella, UMDNJ/CINJ

Study ID Numbers ^ICMJE

CDR0000539677, P30CA072720, CINJ-5004, CINJ-4375

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Stephen W. Marcella, MD, MPH

Cancer Institute of New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP