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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00379119
• Other study ID #: CDR0000455646
• Secondary ID: UCSF-035511
• Status: Terminated
• Phase: N/A
• First received: September 19, 2006
• Last updated: October 9, 2012
• Start date: January 2005
• Est. completion date: October 2009

Study information

• Verified date: October 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• diagnostic laboratory biomarker analysis

• flow cytometry

• physiologic testing

Procedure:
• computed tomography

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of thymus as assessed by CT scan		approximately 4 hours during one session	No
Primary	Fraction and absolute number of circulating peripheral blood CD4+ and CD8+ T cells with a "naive" phenotype		approximately 4 hours during one session	No
Primary	Number of T-cell receptor excision circles in peripheral blood cells		approximately 4 hours during one session	No