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


N/A
50 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Size of thymus as assessed by CT scan

Outcome Time Frame:

approximately 4 hours during one session

Safety Issue:

No

Principal Investigator

Joseph M. McCune, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

CDR0000455646

NCT ID:

NCT00379119

Start Date:

January 2005

Completion Date:

October 2009

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115