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Clinical Trial: Bone Mineral Density as a Risk Factor in Patients With Early Stage Prostate Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) April 2007
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 bone mineral density as a risk factor in patients with early stage prostate cancer.
| Condition | Intervention |
|---|---|
| Osteoporosis Prostate Cancer | Procedure: biological markers Procedure: cancer prevention intervention Procedure: diagnostic test Procedure: dual-energy x-ray absorptiometry Procedure: evaluation of cancer risk factors |
MedlinePlus related topics: Osteoporosis; Prostate Cancer
Study Type: Observational
Study Design: Natural History
Official Title: Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer
Total Enrollment: 40
Study start: June 2003
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 and are known to cause a decrease in BMD.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
- 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
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last Updated: April 18, 2007
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00176579
Health Authority: Unspecified
ClinicalTrials.gov processed this record on May 08, 2007
Resources
- A Consumer's Guide to Fats (Office of Consumer Affairs, OEA, FDA,)
- Artificial Sweeteners

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