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Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2006
First Received: September 19, 2006   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379119
  Purpose

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 Intervention
Prostate Cancer
Other: flow cytometry
Other: laboratory biomarker analysis
Other: physiologic testing
Procedure: computed tomography

Study Type: Observational
Official Title: Androgen Blockade Therapy and Thymic Function in Individuals Over 50 Years of Age With Adenocarcinoma of the Prostate: A Cross-Sectional Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Size of thymus as assessed by CT scan
  • Fraction and absolute number of circulating peripheral blood CD4+ and CD8+ T cells with a "naive" phenotype
  • Number of T-cell receptor excision circles in peripheral blood cells

Estimated Enrollment: 40
Study Start Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379119

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Study Chair: Joseph M. McCune, MD, PhD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000455646, UCSF-035511
Study First Received: September 19, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00379119     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence
Androgens

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 06, 2009