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


N/A
50 Years
75 Years
Not Enrolling
Male
Osteoporosis, Prostate Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Bone mineral density

Outcome Description:

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

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Stephen W. Marcella, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000539677

NCT ID:

NCT00176579

Start Date:

June 2003

Completion Date:

July 2008

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • osteoporosis
  • stage I prostate cancer
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903