Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
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
  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 whether bone mineral density affects cancer recurrence in patients with early stage prostate cancer.


Condition Intervention
Osteoporosis
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 ] [ 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


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:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders 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.

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
  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 ClinicalTrials.gov identifier: NCT00176579

Locations
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
Investigators
Principal Investigator: Stephen W. Marcella, MD, MPH Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Marcella, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00176579     History of Changes
Other Study ID Numbers: CDR0000539677, P30CA072720, CINJ-5004, CINJ-4375
Study First Received: September 13, 2005
Last Updated: August 11, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Osteoporosis
Prostatic Neoplasms
Bone Diseases
Bone Diseases, Metabolic
Genital Diseases, Male
Genital Neoplasms, Male
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014