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

NCT00379119 | Terminated

• 2 other identifiers: CDR0000455646UCSF-035511
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (3)

• Size of thymus as assessed by CT scan

  approximately 4 hours during one session

• Fraction and absolute number of circulating peripheral blood CD4+ and CD8+ T cells with a "naive" phenotype

  approximately 4 hours during one session

• Number of T-cell receptor excision circles in peripheral blood cells

  approximately 4 hours during one session

Interventions

diagnostic laboratory biomarker analysis OTHER

flow cytometry OTHER

physiologic testing OTHER

computed tomography PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals \>50 years of age with prostate cancer

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joseph M. McCune, MD, PhD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: January 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)