NCT06437574RecruitingPhase 2
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
To test the hypothesis that intensive cholesterol lowering (iCL) therapy has anti-tumor immune modulating activity, the investigators will conduct an open-label, single-arm phase II trial in prostate cancer patients who are in active surveillance and undergoing a planned surveillance biopsy in 3-6 months. Eligible patients will initiate iCL with Vytorin®(group 1, 2, and 3), an FDA-approved combination of ezetimibe and simvastatin used to lower atherogenic low density lipoprotein cholesterol (LDL-C) or Ezetimibe (group 4). Starting dose will be determined by current statin use and LDL-C levels. Dose modifications of VYTORIN will be employed with the goal of achieving LDL-C \<70 mg/dl. Dose adjustment is not allowed for ezetimibe.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 23 May 2024
- Start date
- 16 Jul 2024
- Primary completion date
- 29 Feb 2028
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Prostate cancer
- NCT number
- NCT06437574
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 16 Jul 2024 to the primary completion date, 29 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol).
- Already on medication(s) known to interact with Vytorin or Ezetimibe that may prevent protocol-based escalation of cholesterol-lowering therapy from pre-enrollment baseline.
- Already on a PCSK9 inhibitor
Other illness
- Current use of medications contraindicated for use with a statin such as strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone).
- History of allergic or severe reaction to a either study agent.
- History of moderate or severe myalgia with statin use.
- Acute liver failure or decompensated cirrhosis
Other
- Already on maximum VYTORIN dose (10/80)
Who the study is looking for
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as:
- ≥ 50 years of age
- Hypertension
- Hypercholesterolemia
- Diabetes
- Current or former smoker
- First-degree family history of any cardiovascular heart disease
- BMI \> 25
- On hypertension treatment, statin, and/or aspirin therapy
- Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as:
- Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml
- Clinical stage T1c or cT2
- Gleason score 3+3 or 3+4 or 4+3
- Patients on AS with plans for surveillance biopsy
- No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
- Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe.
- Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.