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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00176579 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis Prostate Cancer |
Other: laboratory biomarker analysis Procedure: dual x-ray absorptometry Procedure: evaluation of cancer risk factors |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer |
| Enrollment: | 27 |
| Study Start Date: | June 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
DISEASE CHARACTERISTICS:
Biopsy-confirmed early stage prostate cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | Stephen W. Marcella, MD, MPH | Cancer Institute of New Jersey |
More Information
| Responsible Party: | UMDNJ/CINJ ( Stephen Marcella ) |
| Study ID Numbers: | CDR0000539677, P30CA072720, CINJ-5004, CINJ-4375 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00176579 History of Changes |
| Health Authority: | United States: Federal Government |
|
osteoporosis stage I prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Musculoskeletal Diseases Osteoporosis, Postmenopausal |
Osteoporosis Urogenital Neoplasms Bone Diseases, Metabolic Genital Diseases, Male Bone Diseases Prostatic Neoplasms |