Phase 2 Prostate Cancer Trial, Recruiting NCT06437574 Sponsor: Cedars-Sinai Medical Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06437574
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have signed and dated a consent form agreeing to take part in the study.
  • People who are willing to follow all study procedures and are available for the full duration of the trial.
  • People who have at least one risk factor for cardiovascular (heart and blood vessel) disease, such as: being aged 50 or older, high blood pressure, high cholesterol, diabetes, being a current or former smoker, having a close family member (parent, sibling, or child) with heart disease, having a body mass index (BMI) over 25, or currently taking blood pressure medication, a cholesterol-lowering drug (statin), and/or aspirin.
  • People who have been diagnosed with localised (not spread) prostate cancer that is considered low or intermediate risk, meaning: a PSA blood test result of 20.0 ng/ml or below, an early clinical stage of the cancer (T1c or cT2), and a Gleason score of 3+3, 3+4, or 4+3 (confirm with trial site if unsure about these scores).
  • People who are currently on Active Surveillance (a monitoring approach rather than immediate treatment) and have a planned follow-up biopsy scheduled.
  • People who have not previously received any treatment for prostate cancer, including radiation therapy, chemotherapy, or hormone therapy.
  • People who are able to swallow tablets and are willing to take a once-daily oral medication (either Vytorin or ezetimibe) as directed.
  • People who agree to avoid eating grapefruit or drinking large amounts of grapefruit juice (one quart or more per day) throughout the study.

Who may not be able to join:

  • People who are currently taking certain medications that are known to interact dangerously with statins, including some antifungal, antibiotic, HIV, or antidepressant medications (confirm with trial site for the full list).
  • People who are currently taking medications known to interact with ezetimibe, such as gemfibrozil, cyclosporine, or danazol.
  • People who have had an allergic reaction or a serious adverse reaction to either of the study medications in the past.
  • People who have a history of moderate or severe muscle pain (myalgia) caused by statin use.
  • People who have acute (sudden, severe) liver failure or advanced liver scarring (decompensated cirrhosis).
  • People who are already taking the highest available dose of Vytorin (the 10/80 dose).
  • People who are already taking other medications that are known to interact with Vytorin or ezetimibe in a way that would prevent the study from adjusting the cholesterol-lowering medication as planned.
  • People who are already taking a PCSK9 inhibitor (a type of cholesterol-lowering injection medication).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Hyung Kim, MD, Cedars-Sinai Medical Center

Phone: 310-423-1542

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Cedars-Sinai Medical Center
Registry
ClinicalTrials.gov
Start date
16 July 2024
Est. completion
29 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pre/Post-change in percent prostate infiltrating CD8+ T lymphocytes.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov