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Bone Mineral Density as a Risk Factor in Patients With Early Stage Prostate Cancer - Article


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Dietary Risk Factors




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

Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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 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

Further study details as provided by National Cancer Institute (NCI):

Total Enrollment:  40

Study start: June 2003

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 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

Ages Eligible for Study:  50 Years   -   75 Years,  Genders Eligible for Study:  Male
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00176579


Study chairs or principal investigators

Stephen Marcella, MD, MPH,  Principal Investigator,  Cancer Institute of New Jersey   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000539677; CINJ-5004; CINJ-4375
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

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December 5, 2008



Page Updated: September 6, 2005
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