T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer

Recruiting Phase 2 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Medical University of South Carolina · Other
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About This Trial
This study will evaluate whether simvastatin reduces intraprostatic immunosuppressive microenvironment through YAP-mediated T-reg dysfunction, and increases intraprostatic anti-tumor immune response in men recently diagnosed with localized prostate cancer electing to receive prostatectomy for their care. Half the men will be randomized to receive statins for 8 weeks prior to their surgery, while t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Men with pathologically-confirmed localized prostate cancer determined to be intermediate (stage T2b, or Gleason 7, or PSA 10-20 ng/mL) or high risk (stage T2c, or PSA \>/=20 ng/mL, or Gleason \>/=8) of biochemical recurrence at the time of biopsy 2. Electing to undergo prost…
Contacts

Alan Brisendine

843-792-9007

brisend@musc.edu

CONTACT

Jasmin M Brooks

8439067139

brooksjm@musc.edu

CONTACT