Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
RATIONALE: Studying changes in thymus function in patients who have been undergoing androgen blockade therapy for prostate cancer may help doctors learn more about how well patients will respond to treatment, may help in planning cancer treatment, and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying the effect of androgen blockade therapy on thymus function in older patients who have undergone radical prostatectomy for localized prostate cancer.
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: physiologic testing
Procedure: computed tomography
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Androgen Blockade Therapy and Thymic Function in Individuals Over 50 Years of Age With Adenocarcinoma of the Prostate: A Cross-Sectional Study|
- Size of thymus as assessed by CT scan [ Time Frame: approximately 4 hours during one session ] [ Designated as safety issue: No ]
- Fraction and absolute number of circulating peripheral blood CD4+ and CD8+ T cells with a "naive" phenotype [ Time Frame: approximately 4 hours during one session ] [ Designated as safety issue: No ]
- Number of T-cell receptor excision circles in peripheral blood cells [ Time Frame: approximately 4 hours during one session ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- Determine if inhibition of sex steroid action is associated with increased thymic size in older patients who have undergone radical prostatectomy for localized adenocarcinoma of the prostate.
- Determine if inhibition of sex steroid action is associated with an increase in the absolute number or percentage of circulating "naive" phenotype T cells, and/or an increase in the frequency of T-cell receptor excision circles in peripheral blood cells.
OUTLINE: This is a nonrandomized, single-blind, cohort study. Patients are stratified according to hormonal therapy after surgery (yes vs no).
Patients undergo CT scan of the thymus. Blood samples are analyzed by flow cytometry to determine phenotype of T cells.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379119
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Joseph M. McCune, MD, PhD||University of California, San Francisco|