RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients randomized to the statin group will receive moderate intensity simvastatin (40mg, day) for eight weeks until the date of prostatectomy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether simvastatin helps the immune system fight cancer inside the prostate. It is for men recently diagnosed with prostate cancer that has not spread who plan to have surgery to remove the prostate. Half will be chosen by chance to take simvastatin for 8 weeks before surgery, and half will get usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men with prostate cancer confirmed by a tissue sample that has not spread. Tests must show a medium or high risk of the cancer coming back, based on cancer stage, Gleason score (how abnormal the cancer looks), or PSA level (a blood test).
  • Plan to have surgery to remove the prostate.
  • Can give written consent and are willing to complete study steps.

Who can't join

  • Take a statin now or took one in the past 12 months; stopped a statin because of side effects; or take another cholesterol drug called a fibrate, bile acid sequestrant, or niacin.
  • Take a drug that cannot be used with 40 mg simvastatin: gemfibrozil, cyclosporine, danazol, itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, or nefazodone.
  • Take verapamil, diltiazem, amiodarone, ranolazine, or amlodipine, which require a lower simvastatin dose.
  • Have LDL ('bad') cholesterol below 50 mg/dL, have diabetes, or take diabetes medicine.
  • Have known or suspected cancer spread; had chemotherapy, hormone treatment, or radiation before or after cancer treatment; or had another cancer in the past 24 months, except non-melanoma skin cancer.
  • Have had a heart attack or stroke.
  • Have long-term liver disease, such as hepatitis or liver scarring; a liver blood test called ALT above 1.5 times the lab's upper normal limit; or stage 4 or 5 kidney disease (kidney filtering level below 30 mL/min).
  • Have a history of muscle disease or muscle swelling, with a muscle blood test called creatine kinase above 3 times the lab's upper normal limit.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 prostatectomy; 3. Ability to provide written informed consent and willing to complete study procedures. Exclusion Criteria: 1. Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin); 2. Current use of medications contraindicated for concomitant use with 40mg simvastatin: * Gemfibrozil * Cyclosporine * Danazol * CYP3A4 inhibitors: itraconazole; ketoconazole; posaconazole; erythromycin; clarithromycin; telithromycin; HIV protease inhibitors; boceprevir; telaprevir; nefazodone 3. Current use of medications requiring lower dose of simvastatin not already listed as exclusions criteria: * Verapamil * Diltiazem * Amiodarone * Ranolazine * Calcium channel blockers: verapamil; diltiazem; amlodipine 4. Men with low-density lipoprotein cholesterol \<50mg/dL 5. Statin use in the previous 12 months; 6. Discontinued statin use because of statin-related adverse event; 7. Evidence or suspicion of metastases; 8. Prior neoadjuvant or adjuvant chemotherapy, hormone therapy, or radiation therapy; 9. History of non-prostate cancer other than non-melanoma skin cancer in the last 24 months; 10. Diagnosed diabetes or currently taking diabetes medications 11. Prior myocardial infarction or stroke 12. Chronic liver disease (hepatitis or cirrhosis) or abnormal liver function (\>1.5x clinical laboratory's upper limit of normal alanine aminotransferase); 13. Stage 4 or 5 chronic kidney disease (Creatinine clearance / estimated glomerular filtration rate \< 30 mL/min calculated by Cockgroft-Gault formula); 14. History of myopathy or inflammatory muscle disease (\>3x clinical laboratory's upper limit of normal creatine kinase).

Study sites (2)

GA

SC