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

NCT00176579 | Completed DMC

• 4 other identifiers: CDR0000539677P30CA072720CINJ-5004CINJ-4375
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Prostate Cancer

Keywords

osteoporosis; stage I prostate cancer

Outcome Measures

Primary Outcomes (2)

• Bone mineral density

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

  Baseline

• Prostate Specific Antigen

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

  Baseline, every 6 months for 3 years

Interventions

dual x-ray absorptiometry PROCEDURE

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

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

New Brunswick, New Jersey, 08903, United States

Location

Related Links

• Clinical trial summary from Clinicaltrials.gov website

MeSH Terms

Conditions

Osteoporosis; Prostatic Neoplasms

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Stephen W. Marcella, MD, MPH

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 12, 2011

Record last verified: 2011-08

Locations

US (1)