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Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176579
First received: September 13, 2005
Last updated: August 11, 2011
Last verified: August 2011
History of Changes

September 13, 2005
August 11, 2011
June 2003
July 2008   (final data collection date for primary outcome measure)
  • Bone mineral density [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    DXA scan will be done after patient signs consent and eligibilty is confirmed
  • Prostate Specific Antigen [ Time Frame: Baseline, every 6 months for 3 years ] [ Designated as safety issue: No ]
    PSA will be measured to look for biochemical recurrence of prostate cancer
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Complete list of historical versions of study NCT00176579 on ClinicalTrials.gov Archive Site
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Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer

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:

  • 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.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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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.
  • Osteoporosis
  • Prostate Cancer
Procedure: dual x-ray absorptiometry
Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Male
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00176579
CDR0000539677, P30CA072720, CINJ-5004, CINJ-4375
Yes
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Stephen Marcella, UMDNJ/CINJ
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Stephen W. Marcella, MD, MPH Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP