RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-11
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05586360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Electing to undergo prostatectomy;
  3. 3. Ability to provide written informed consent and willing to complete study procedures.
  1. 1. Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
  2. 2. Current use of medications contraindicated for concomitant use with 40mg simvastatin:
  3. * Gemfibrozil
  4. * Cyclosporine
  5. * Danazol
  6. * CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone
  7. 3. Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria:
  8. * Verapamil
  9. * Diltiazem
  10. * Amiodarone
  11. * Ranolazine
  12. * Calcium channel blockers: verapamil; diltiazem; amlodipine
  13. 4. Men with low-density lipoprotein cholesterol \<50mg/dL
  14. 5. Statin use in the previous 12 months;
  15. 6. Discontinued statin use because of statin-related adverse event;
  16. 7. Evidence or suspicion of metastases;
  17. 8. Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy;
  18. 9. History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months;
  19. 10. Diagnosed diabetes or currently taking diabetes medications
  20. 11. Prior myocardial infarction or stroke
  21. 12. Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (\>1.5x clinical laboratory's upper limit of normal alanine aminotransferase);
  22. 13. Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate \< 30 mL/min calculated by Cockgroft-Gault formula);
  23. 14. History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).

Contacts and Locations

Study Contact

Alan Brisendine
CONTACT
843-792-9007
brisend@musc.edu
Jasmin M Brooks
CONTACT
8439067139
brooksjm@musc.edu

Principal Investigator

Michael Marrone, PhD
PRINCIPAL_INVESTIGATOR
Public Health Sciences

Study Locations (Sites)

Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Michael Marrone, PhD, PRINCIPAL_INVESTIGATOR, Public Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2024-03-11
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • Prostate cancer
  • Neoadjuvant
  • Statin

Additional Relevant MeSH Terms

  • Prostate Cancer