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

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

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
Prostate Cancer
Procedure: dual x-ray absorptiometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: Baseline ]
    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 ]
    PSA will be measured to look for biochemical recurrence of 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)
Intervention Details:
    Procedure: dual x-ray absorptiometry
    Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
Detailed Description:


  • 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.


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.


  • 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


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00176579

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Stephen Marcella, UMDNJ/CINJ Identifier: NCT00176579     History of Changes
Other Study ID Numbers: CDR0000539677
P30CA072720 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2005
Last Updated: August 11, 2011

Keywords provided by Rutgers, The State University of New Jersey:
stage I prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on April 28, 2017