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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00176579
• Other study ID #: CDR0000539677
• Secondary ID: P30CA072720CINJ-
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 11, 2011
• Start date: June 2003
• Est. completion date: July 2008

Study information

• Verified date: August 2011
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• dual x-ray absorptiometry
Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	DXA scan will be done after patient signs consent and eligibilty is confirmed	Baseline	No
Primary	Prostate Specific Antigen	PSA will be measured to look for biochemical recurrence of prostate cancer	Baseline, every 6 months for 3 years	No

External Links

•   Clinical trial summary from Clinicaltrials.gov website