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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 the other half will receive standard of care.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Electing to undergo prostatectomy;

• Ability to provide written informed consent and willing to complete study procedures.

Locations
United States
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
South Carolina
Hollings Cancer Center at Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Alan Brisendine
brisend@musc.edu
843-792-9007
Backup
Jasmin M Brooks
brooksjm@musc.edu
8439067139
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 36
Treatments
Experimental: Simvastatin
Patients randomized to the statin group will receive 40 mg oral simvastatin QD for eight weeks prior to prostatectomy, including the day of surgery.
No_intervention: Control
Patients randomized to the control group receive no intervention prior to prostatectomy.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov