Status:
TERMINATED
Effect of Androgen Blockade Therapy on Thymus Function in Older Patients Who Have Undergone Radical Prostatectomy for Localized Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
50+ years
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 tr...
Detailed 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 pro...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00379119
Start Date
January 1 2005
End Date
October 1 2009
Last Update
October 11 2012
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115