Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Prostate cancer is the most commonly diagnosed cancer among males in the U.S. More than
220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000
will die of this disease.
Androgen deprivation, the elimination of testosterone and its active metabolites, remains the
single most effective intervention available for the treatment of advanced prostate
carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate
cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune
system and may be a more effective and long lasting means of inducing immunity to prostate
tissue.
This study will treat clinically localized prostate cancer patients with either estrogens, or
standard androgen deprivation without estrogens, prior to prostatectomy in order more
completely to describe immune regulation by estradiol in men. Control tissue from patients
who have not been treated with androgen deprivation will be procured from the Northwest
Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons
against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue
samples and blood samples will be assessed for immune system changes.
Phase:
Phase 2
Details
Lead Sponsor:
University of Washington
Collaborators:
Pacific Northwest SPORE Pacific Northwest SPORE (Specialized Projects in Oncology Research Excellence)