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Heart-Safe Study: Managing Heart Risk in Prostate Cancer Patients on ARPI Therapy

This study, called Heart-Safe, is for men with prostate cancer (localized, very-high risk, lymph-node positive, or Stage IV) who are receiving androgen receptor pathway inhibitor (ARPI) therapy. This therapy, while important for prostate cancer, can increase your risk for heart problems. The study aims to see if early heart care, through a cardio-oncology referral and recommendations to your regular doctors, can help manage these risks. We are looking for 80 participants. Success will be measured by how many people start or change heart medications within 3 months after receiving these heart care interventions. This study focuses on men aged 45-65 with at least two heart risk factors, or over 65 with at least one heart risk factor.

Study design
This is an interventional study with a planned enrollment of 80 male participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months post-intervention to measure changes in heart medication use.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223385

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

Recruiting
PHASE2Ages 45+InterventionalSupportive care
Cedars-Sinai Medical Center
~80 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Cardio-Oncology ReferralNotification to PCP/General Cardiologist

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of any CV medication Initiation and/or Change
Measured over 3 Months Post-Intervention

Conditions

Prostate Cancer (Diagnosis)
Prostate Cancer Stage IV
CV Risk

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Katelyn Atkins, MD, PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
  • Leslie Ballas, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
310-423-5842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Prior ARPI therapy exposure \> 6 months duration.
Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).

What this trial measures

  • Rate of any CV medication Initiation and/or Change3 Months Post-Intervention

    To evaluate the rate of any CV medication initiation and/or change at 3-months following cardio-oncology consultation versus standard of care. Rate of any CV medication intervention at 3-months (Note: CV medication defined as: lipid-lowering, anti-hypertensive, anti-anginal, anti-platelet, anti-arrhythmic, heart failure medications)