Prostate Cancer Clinical Trial

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

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.

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Full 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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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:

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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)

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT00379119

Recruitment Status:

Terminated

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT00379119

Recruitment Status:

Terminated

Sponsor:


University of California, San Francisco

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