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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| CINJ-5004 | |||
| CINJ-4375 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual x-ray absorptiometry | Procedure | Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density |
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density | DXA scan will be done after patient signs consent and eligibilty is confirmed | Baseline |
| Prostate Specific Antigen | PSA will be measured to look for biochemical recurrence of prostate cancer | Baseline, every 6 months for 3 years |
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DISEASE CHARACTERISTICS:
Biopsy-confirmed early stage prostate cancer
Prostate specific antigen < 12 ng/mL
Gleason score ≥ 6
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen W. Marcella, MD, MPH | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from Clinicaltrials.gov website | View source |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |