Status:
NOT_YET_RECRUITING
High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Prostate Cancer (Diagnosis)
Prostate Cancer Stage IV
Eligibility:
MALE
45+ years
Phase:
PHASE2
Brief Summary
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 the...
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).
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07223385
Start Date
December 1 2025
End Date
December 1 2029
Last Update
October 31 2025
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048