Trials
Search / Trial NCT06437574

Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer

Launched by CEDARS-SINAI MEDICAL CENTER · May 29, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether intensive cholesterol-lowering therapy can help improve the immune response against prostate cancer. The researchers are focusing on men with localized prostate cancer who are currently under active surveillance, meaning their cancer is being monitored but not treated right now. Participants in the trial will take a medication called Vytorin®, which combines two drugs to lower cholesterol. The goal is to lower their “bad” cholesterol levels to less than 70 mg/dl. The trial is looking for men aged 65 to 74 who have certain risk factors for heart disease and meet specific criteria related to their prostate cancer diagnosis.

If you or a family member are considering participation, you will need to provide consent and be willing to follow the study procedures, which include taking the medication daily. You should be aware that participants must avoid grapefruit and certain medications that could interfere with the study drugs. This trial is currently recruiting participants, and it could be an opportunity to contribute to research that may improve treatments for prostate cancer.

Gender

MALE

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 a PCSK9 inhibitor

Trial Officials

Hyung Kim, MD

Principal Investigator

Cedars-Sinai Medical Center

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0