Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00379119
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-21
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-09
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size of thymus as assessed by CT scan	approximately 4 hours during one session
Fraction and absolute number of circulating peripheral blood CD4+ and CD8+ T cells with a "naive" phenotype	approximately 4 hours during one session
Number of T-cell receptor excision circles in peripheral blood cells	approximately 4 hours during one session

Trial Locations

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States