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Trial record 91 of 279 for:    prostate cancer AND localized | ( Map: United States )

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date September 19, 2006
First Posted Date September 21, 2006
Last Update Posted Date October 11, 2012
Study Start Date January 2005
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2012)
  • 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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00379119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
Official Title Androgen Blockade Therapy and Thymic Function in Individuals Over 50 Years of Age With Adenocarcinoma of the Prostate: A Cross-Sectional Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals >50 years of age with prostate cancer
Condition Prostate Cancer
Intervention
  • Other: diagnostic laboratory biomarker analysis
  • Other: flow cytometry
  • Other: physiologic testing
  • Procedure: computed tomography
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 9, 2012)
20
Original Enrollment Not Provided
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00379119
Other Study ID Numbers CDR0000455646
UCSF-035511
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: Joseph M. McCune, MD, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2012