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TerminatedNCT00379119Updated Oct 11, 2012

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

An observational study in Prostate Cancer, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-10-11.

Sponsored by University of California, San Francisco · Observational

Why this study was terminated
low accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
50 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Individuals >50 years of age with prostate cancer

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)

Interventions

  • Otherdiagnostic laboratory biomarker analysis
  • Otherflow cytometry
  • Otherphysiologic testing
  • Procedurecomputed tomography
06

What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00379119
Lead sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 21, 2006
Start date
Jan 2005
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Oct 11, 2012

Study contacts

Joseph M. McCune, MD, PhD
study chair · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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