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

U

University of Medicine and Dentistry of New Jersey

Status

Completed

Conditions

Osteoporosis
Prostate Cancer

Treatments

Procedure: dual x-ray absorptiometry

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00176579
CINJ-5004
P30CA072720 (U.S. NIH Grant/Contract)
CDR0000539677
CINJ-4375

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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