NCT06437574 Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer
| NCT ID | NCT06437574 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2024-07-16 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2024-07-16 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. At least one Atherosclerotic Cardiovascular Disease (ASCVD) risk factor, such as: 1. ≥ 50 years of age 2. Hypertension 3. Hypercholesterolemia 4. Diabetes 5. Current or former smoker 6. First-degree family history of any cardiovascular heart disease 7. BMI \> 25 8. On hypertension treatment, statin, and/or aspirin therapy 4. Patients with clinically localized prostate cancer. That is Low or intermediate risk prostate cancer defined as: 1. Pre-operative PSA (Prostate Specific Antigen) ≤ 20.0 ng/ml 2. Clinical stage T1c or cT2 3. Gleason score 3+3 or 3+4 or 4+3 5. Patients on AS with plans for surveillance biopsy 6. No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy 7. Ability to take oral medication and be willing to adhere to once daily, oral Vytorin or ezetimibe. 8. Agree to avoid consumption of grapefruit and grapefruit juice ≥ one quart per day throughout study duration. Exclusion Criteria: 1. 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). 2. Current use of medications contraindicated for use with ezetimibe (i.e., gemfibrozil, cyclosporine, or danazol). 3. History of allergic or severe reaction to a either study agent. 4. History of moderate or severe myalgia with statin use. 5. Acute liver failure or decompensated cirrhosis 6. Already on maximum VYTORIN dose (10/80) 7. 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. 8. Already on a PCSK9 inhibitor
Contact & Investigator
Hyung Kim, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06437574 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06437574 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06437574 currently recruiting?
Yes, NCT06437574 is actively recruiting participants. Contact the research team at Amy.Hoang@cshs.org for enrollment information.
Where is the NCT06437574 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06437574 clinical trial?
NCT06437574 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Hyung Kim, MD at Cedars-Sinai Medical Center. The trial plans to enroll 140 participants.
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