A Phase 2 interventional study of Cardio-Oncology Referral and Notification to PCP/General Cardiologist in Prostate Cancer (Diagnosis), Prostate Cancer Stage IV and CV Risk, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Supportive care
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 patients with CHIP. However, the mechanistic link and clinical consequence are less understood. Therefore, it is critical to study the CV impact of CHIP and metabolic perturbations in patients with PC treated with ARSI therapy.
We plan to address these critical gaps by testing our innovative hypothesis that early cardio-oncology intervention with aggressive guidelines-based CV optimization during ARPI therapy will reduce CV risk and that CHIP and metabolomics will help identify adverse metabolic remodeling to improve CV risk prediction.
Robust epidemiological and clinical trial data consistently demonstrate that patients with PC are poorly optimized from a CV risk modification perspective, and existing CV risk models do not perform well in patients with cancer. The data demonstrates that for most patients, the status quo is insufficient 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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 80 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Age > 65 years old and at least one CV risk factor, or age 45-65 years with at least two CV risk factors:
Exclusion Criteria:
Referral to cardio-oncology for guidelines-based personalized cardio-oncology management
Other: Cardio-Oncology Referral
Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy
Other: Notification to PCP/General Cardiologist
Referral to cardio-oncology for guidelines-based personalized cardio-oncology management
Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy
Rate of any CV medication Initiation and/or Change
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)
Time frame: 3 Months Post-Intervention
The Rate of Compliance with CV Therapeutic Medication Intervention
To determine the rate of compliance with CV therapeutic medication intervention at 6 and 12 months
Time frame: 6 and 12 Months Post Intervention
Rate of Statin Intervetion
To determine the rate of statin intervention at 3 months
Time frame: 3 Months Post Intervention
Rate of Compliance with Statin Medication Intervention
To determine the rate of compliance with statin medication intervention at 6 and 12 months
Time frame: 6 and 12 Months Post Intervention
Rate of any CV Medication Intervention
To determine the rate of any CV medication intervention at 6 months
Time frame: 6 Months Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (low density lipoprotein \[LDL\])
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (systolic blood pressure)
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (hemoglobin A1c)
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (body mass index)
Time frame: 3, 6, and 12 Month Post-Intervention
Rate of Coronary Artery Disease Testing
To determine the rate of coronary artery disease (CAD) testing (coronary CT angiograms, CAC scans, stress tests, and invasive coronary angiograms)
Time frame: 3, 6, and 12 Month Post-Intervention
Rate of new CV or Cardiac Diagnosis
To determine the rate of new CV or cardiac diagnosis
Time frame: 3, 6, and 12 Month Post-Intervention
One-Year MACE Rate
To determine the one-year MACE rate
Time frame: 12 Months Post-Intervention
Rate of Grade ≥ 2 Cardiac CTCAE
To determine one-year rate of grade ≥ 2 cardiac common terminology criteria for adverse events (CTCAE)
Time frame: 12 Month Post-Intervention
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Cedars-Sinai Medical Center