Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00379119|
Recruitment Status : Terminated (low accrual)
First Posted : September 21, 2006
Last Update Posted : October 11, 2012
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: diagnostic laboratory biomarker analysis Other: flow cytometry Other: physiologic testing Procedure: computed tomography|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Androgen Blockade Therapy and Thymic Function in Individuals Over 50 Years of Age With Adenocarcinoma of the Prostate: A Cross-Sectional Study|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
- Size of thymus as assessed by CT scan [ Time Frame: approximately 4 hours during one session ]
- 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 ]
- Number of T-cell receptor excision circles in peripheral blood cells [ Time Frame: approximately 4 hours during one session ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|