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

NCT ID: NCT07223385

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

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 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.

Conditions

Prostate Cancer (Diagnosis); Prostate Cancer Stage IV; CV Risk

Keywords

High-Risk; Lymph-node positive; ARPI Therapy; CV Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cardo-Oncolody Referral

Referral to cardio-oncology for guidelines-based personalized cardio-oncology management

Group Type: EXPERIMENTAL

Cardio-Oncology Referral

Intervention Type: OTHER

Referral to cardio-oncology for guidelines-based personalized cardio-oncology management

PCP/General Cardiology Care

Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy

Group Type: ACTIVE_COMPARATOR

Notification to PCP/General Cardiologist

Intervention Type: OTHER

Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy

Interventions

Cardio-Oncology Referral

Referral to cardio-oncology for guidelines-based personalized cardio-oncology management

Intervention Type: OTHER

Notification to PCP/General Cardiologist

Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Katelyn Atkins

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katelyn Atkins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Leslie Ballas, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Clinical Trial Recruitment Navigator

Role: CONTACT

Phone: 13104232133

Email: cancer.trial.info@cshs.org

Facility Contacts

Clinical Trial Recruitment Navigator

Role: primary

Other Identifiers

IIT2025-09-BALLAS-ATKINS-HEART

Identifier Type: -

Identifier Source: org_study_id