Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
NCT ID: NCT00379119
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
20 participants
OBSERVATIONAL
2005-01-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
diagnostic laboratory biomarker analysis
flow cytometry
physiologic testing
computed tomography
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph M. McCune, MD, PhD
Role: STUDY_CHAIR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCSF-035511
Identifier Type: -
Identifier Source: secondary_id
CDR0000455646
Identifier Type: -
Identifier Source: org_study_id