Clinical trial NCT00176579: Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
Official title: Assessing Bone Mineral Density as a Risk Factor for Early Clinically Significant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Prostate Cancer
Keywords: osteoporosis
stage I prostate cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 27
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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

Primary outcomes:
measure: Bone mineral density
timeFrame: Baseline
measure: Prostate Specific Antigen
timeFrame: Baseline, every 6 months for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Stephen W. Marcella, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: