NCT05586360

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
15mo left

Started Mar 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2024Aug 2027

First Submitted

Initial submission to the registry

October 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

October 13, 2022

Last Update Submit

March 2, 2026

Conditions

Prostate Cancer

Keywords

Prostate cancerNeoadjuvantStatin

Outcome Measures

Primary Outcomes (1)

  • Intra-prostatic YAP-mediated T-reg dysfunction in total tissue area

    Number of men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy that have greater intra-prostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group. Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.

    8 weeks

Secondary Outcomes (3)

  • Intra-prostatic YAP-mediated T-reg dysfunction, limited to tumor infiltrating Tregs

    8 weeks

  • Intra-prostatic YAP-mediated T-reg dysfunction, limited to T-regs in adjacent normal and stromal tissue

    8 weeks

  • Intra-prostatic anti-tumor immune response

    8 weeks

Study Arms (2)

Simvastatin

EXPERIMENTAL

Patients randomized to the statin group will receive 40 mg oral simvastatin QD for eight weeks prior to prostatectomy, including the day of surgery.

Drug: Simvastatin 40mg

Control

NO INTERVENTION

Patients randomized to the control group receive no intervention prior to prostatectomy.

Interventions

Simvastatin 40mgDRUG

Simvastatin 40mg taken orally daily for 8 weeks

Simvastatin

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThis trial is focused on prostate cancer, a cancer of a male organ, and is applicable to men only. Men from all racial and ethnic groups are eligible to participate in this trial.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Current statin use or use of non-statin lipid-lowering drug (fibrates, bile acid sequestrants, or niacin);
  • 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
  • Verapamil
  • Diltiazem
  • Amiodarone
  • Ranolazine
  • Calcium channel blockers: verapamil; diltiazem; amlodipine
  • Men with low-density lipoprotein cholesterol \<50mg/dL
  • Statin use in the previous 12 months;
  • Discontinued statin use because of statin-related adverse event;
  • Evidence or suspicion of metastases;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Michael Marrone, PhD

    Public Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Brisendine

CONTACT

843-792-9007brisend@musc.edu

Jasmin M Brooks

CONTACT

8439067139brooksjm@musc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 19, 2022

Study Start

March 11, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(2)