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

Tracking Information
First Submitted Date	September 13, 2005
First Posted Date	September 15, 2005
Last Update Posted Date	August 12, 2011
Study Start Date	June 2003
Actual Primary Completion Date	July 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: August 11, 2011)	Bone mineral density [ Time Frame: Baseline ]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 ]PSA will be measured to look for biochemical recurrence of prostate cancer
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00176579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
Official Title	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 Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	Osteoporosis; Prostate Cancer
Intervention	Procedure: dual x-ray absorptiometry; Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 12, 2009)	27
Original Enrollment; (submitted: September 13, 2005)	60
Actual Study Completion Date	July 2008
Actual Primary Completion Date	July 2008 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: Male
Ages	50 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00176579
Other Study ID Numbers	CDR0000539677; P30CA072720 ( U.S. NIH Grant/Contract ); CINJ-5004; CINJ-4375
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Stephen Marcella, UMDNJ/CINJ
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
PRS Account	Rutgers, The State University of New Jersey
Verification Date	August 2011