Sponsor: National Cancer Institute
Sponsor Study ID: R00CA246097
Study Title: T Reg Function Changes: A Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
CTO #: 103472
NCT Number: NCT05586360
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Prostate
Study Objectives: To evaluate whether men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy have greater intraprostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group. To determine whether men randomized to the statin group have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to tumor-infiltrating T-regs only. To determine whether men randomized to the statin group have greater YAP-mediated T-reg dysfunction compared to men randomized to the control group restricting to the subset of T-regs in the adjacent normal and stromal tissue area. To determine whether men randomized to the statin group have greater intraprostatic anti-tumor immune response compared to men randomized to the control group.