Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00176579 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: August 12, 2011
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Tracking Information | ||||
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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 |
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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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case Control Time Perspective: Prospective |
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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 |
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Intervention | Procedure: dual x-ray absorptiometry
Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
27 | |||
Original Enrollment |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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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 |
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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 |
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PRS Account | Rutgers, The State University of New Jersey | |||
Verification Date | August 2011 |