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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2005

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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


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.


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.

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)
We found this trial at
1
site
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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