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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379119
Recruitment Status : Terminated (low accrual)
First Posted : September 21, 2006
Last Update Posted : October 11, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Prostate Cancer Other: diagnostic laboratory biomarker analysis Other: flow cytometry Other: physiologic testing Procedure: computed tomography

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Size of thymus as assessed by CT scan [ Time Frame: approximately 4 hours during one session ]
  2. 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 ]
  3. Number of T-cell receptor excision circles in peripheral blood cells [ Time Frame: approximately 4 hours during one session ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals >50 years of age with prostate cancer


  • Histologically confirmed adenocarcinoma of the prostate
  • Underwent prior radical prostatectomy as local definitive therapy for prostate cancer
  • Meets criteria for 1 of the following strata:

    • Has received ≥ 9 months of androgen blockade therapy (either single-agent luteinizing hormone-releasing hormone or combined androgen blockade) for serologic progression after surgery

      • Serologic progression defined as a rising prostate-specific antigen, which has risen serially on two determinations (from baseline) ≥ 1 week apart, and no objective evidence of metastatic disease
      • Prior radiotherapy for serologic progression allowed
    • Did not receive any form of androgen blockade therapy within the past 9 months
  • No metastatic disease by abdominal/pelvic CT scan and whole-body scan


  • Able to tolerate CT scanning in the supine position
  • No prior medical condition known to have effects on the thymus, including myasthenia gravis, lymphoma, hyperthyroidism, or cachexia
  • No autoimmune disorders
  • No acute illness, including active infection requiring antibiotics


  • See Disease Characteristics
  • No prior systemic chemotherapy
  • No prior immunological therapy
  • No prior single-agent antiandrogen (e.g., high-dose bicalutamide)
  • No prior or concurrent 5-alpha reductase inhibitors (e.g., finasteride), PC-SPES, or estrogen-containing nutraceuticals
  • No concurrent systemic steroid therapy (topical steroids allowed)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00379119

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
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Study Chair: Joseph M. McCune, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT00379119    
Other Study ID Numbers: CDR0000455646
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by University of California, San Francisco:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases