Cholesterol-lowering therapy for prostate cancer patients

Lowering Cholesterol in Prostate Cancer to Target Rapamycin-Insensitive Companion Of MTOR (TORC2) in T-Cell Surface Glycoprotein CD8 Alpha Chain (CD8+) Lymphocytes

This study is testing whether lowering cholesterol with medication can help boost the immune system in men with prostate cancer who are being closely monitored.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06437574 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effects of intensive cholesterol-lowering therapy on immune modulation in prostate cancer patients who are under active surveillance. Participants will receive Vytorin® or Ezetimibe to achieve low-density lipoprotein cholesterol (LDL-C) levels below 70 mg/dl. The study aims to assess the potential anti-tumor effects of this therapy during the planned surveillance biopsy period. The trial is open-label and single-arm, focusing on patients with localized prostate cancer and specific cardiovascular risk factors.

Who should consider this trial

Good fit: Ideal candidates are men aged 50 and older with localized prostate cancer and at least one cardiovascular risk factor.

Not a fit: Patients with advanced prostate cancer or those who have previously undergone treatment for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance immune response against prostate cancer and improve patient outcomes.

How similar studies have performed: While the specific combination of cholesterol-lowering therapy and prostate cancer is novel, similar approaches targeting immune modulation have shown promise in other studies.

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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Hyung Kim, MD — Cedars-Sinai Medical Center
• Study coordinator: Amy Hoang

Conditions Prostate Cancer