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Study identifier: NCT07223385 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Prostate Cancer (Diagnosis) · Prostate Cancer Stage IV · CV Risk  ·  Sponsor: Cedars-Sinai Medical Center

PhasePhase 2
Planned participants80
Who can joinMale, 45 Years to no upper limit
Healthy volunteersNo

About this study

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 across thousands of patients. Age-related expansion of hematopoietic clones carrying recurrent somatic mutations, termed clonal hematopoiesis of indeterminate potential (CHIP) has recently been identified as a significant driver of atherosclerosis, doubling the risk of coronary heart disease. Notably, while CHIP is detectable in \~10% of persons over 70 years old, it is enriched in patients with solid malignancies, and radiotherapy exposure is among the most decisive risk factors for developing CHIP12-15. The inflammation-related metabolic signals are activated androgen signaling and exacerbated in…

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trial Recruitment Navigator  ·  13104232133  ·  GroupCancerTrialInformation@cshs.org

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Locations (1)

Cedars Sinai Medical CenterLos Angeles, California, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07223385