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OpenTrials
Completed

NCT Number: NCT00176579

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

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Key information

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual X-ray Absorptiometry

Procedure

Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density

Primary outcomes

  1. Bone mineral density

    Time frame: Baseline

    DXA scan will be done after patient signs consent and eligibilty is confirmed

  2. Prostate Specific Antigen

    Time frame: Baseline, every 6 months for 3 years

    PSA will be measured to look for biochemical recurrence of prostate cancer

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
Aug 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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