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High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)

RecruitingPhase 2Ages 45 Years - anyMaleCedars-Sinai Medical Center
NCT07223385 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death. Both pre-existing CVD and the use of androgen deprivation therapy (ADT)-a key cornerstone of treatment for men with locally advanced or metastatic PC1,2 contribute to increased CV risk. ADT has been associated with adverse metabolic effects, including increased central adiposity, elevated low-density lipoprotein (LDL) levels, impaired glycemic control, and arterial wall remodeling and endothelial dysfunction The data demonstrates that for most patients, the status quo is insufficient6 and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies. Mitigation strategies, like the addition of statins as primary prevention, have shown decrease in MI/CHD death acros

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📋 Eligibility rules (as published)
Inclusion Criteria: * Prostate cancer with localized, very-high risk, lymph-node positive, and/or metastatic (Stage IV) disease. * Being treated with ARPI therapy with intended duration ≥ 18 months. * Age \> 65 years old and at least one CV risk factor, or age 45-65 years with at least two CV risk factors: * Hypertension * Hyperlipidemia * Diabetes mellitus * Family history of early CAD (male first-degree relative (father or brother) with CAD before age 55; female first-degree relative (mother or sister) with CAD before age 65) * Presence of coronary artery calcium (CAC) on chest CT imaging * ECOG 0-2 * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Prior ARPI therapy exposure \> 6 months duration. * Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).
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What it tests

  • Cardio-Oncology Referral
  • Notification to PCP/General Cardiologist
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Where

1 site
Cedars Sinai Medical Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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