Heart-Healthy Cardio-Oncology Check for Prostate Cancer on ARPI Therapy
Official title: High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
Run by Cedars-Sinai Medical Center · NCT07223385 · Data updated 2026-11-12
This trial tests whether a cardio-oncology referral and shared care between your cardiologist and your primary clinician can help reduce heart-attack and stroke risk in men with advanced prostate cancer who are taking ARPI therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years and up |
| Sex | Men only |
| Enrollment | 80 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | July 15, 2026 |
| Main results expected | August 2030 |
| Study ends | August 2030 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07223385 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with localized to metastatic prostate cancer on ARPI therapy for at least 18 months, aged 65+ (or 45–65 with multiple CV risk factors), and ECOG 0–2.
✕Probably not a fit
Patients without significant cardiovascular risk factors or those not proceeding with ARPI therapy may have limited or no cardiovascular benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 interventional study enrolling men with high-risk or advanced prostate cancer who are on ARPI therapy for at least 18 months. Eligible participants are 65 or older (or 45–65 with multiple cardiovascular risk factors) and have one or more risk factors such as hypertension, high cholesterol, diabetes, a family history of early heart disease, or evidence of coronary calcium. The intervention involves referral to cardio-oncology and notification to the patient’s PCP or general cardiologist to coordinate risk-reduction strategies. The goal is to identify and mitigate cardiovascular risk early to reduce heart-related events while continuing cancer treatment. Locations are Cedars-Sinai Medical Center in Los Angeles, with sponsor support from Cedars-Sinai Medical Center.
Why it matters
Potential benefit: If successful, participants may experience better control of cardiovascular risk and reduced chances of heart problems while receiving ARPI therapy.
How similar studies have gone: Prior work suggests that statin-based primary prevention and early cardiovascular risk management can reduce heart events in high-risk cancer patients; this study tests a coordinated cardio-oncology approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Cedars Sinai Medical Center
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Katelyn Atkins, MD, PhD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Recruitment Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 310-423-5842
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.