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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Medical University of South Carolina
Study ID
NCT05586360
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Simvastatin 40mg — DRUG
    Simvastatin 40mg taken orally daily for 8 weeks

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area [ Time Frame: 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
John Pattaras, MD
[email protected]
(404) 778-4898
Sierra Thomson
[email protected]
John Pattaras, MD (PRINCIPAL_INVESTIGATOR)
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425
Alan Brisendine, CCRP
[email protected]
843-792-9007
Jasmin Brooks
[email protected]
Michael Marrone, PhD (PRINCIPAL_INVESTIGATOR)
Stephen Savage, MD (SUB_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Emory University· Atlanta, GAHollings Cancer Center at Medical University of South Carolina· Charleston, SC

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