Prostate Cancer (Diagnosis)Phase 2NCT07223385
High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
A Phase 2 study testing Cardio-Oncology Referral and Notification to PCP/General Cardiologist in people with Prostate Cancer (Diagnosis) and Prostate Cancer Stage IV, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Prostate Cancer Stage IV, CV Risk
- What is being tested?
- Cardio-Oncology Referral and Notification to PCP/General Cardiologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- Prior ARPI therapy exposure > 6 months duration.
- Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katelyn Atkins, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 13104232133, GroupCancerTrialInformation@cshs.org
Katelyn Atkins, MD, PhD
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 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.
Read more
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.
- Being tested
- Cardio-Oncology Referral, Notification to PCP/General Cardiologist
- Keywords
- High-Risk, Lymph-node positive, ARPI Therapy, CV Risk Factors
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-Oncology ReferralOther
Referral to cardio-oncology for guidelines-based personalized cardio-oncology management
Notification to PCP/General CardiologistOther
Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy
| Study group | Role | What they receive |
|---|---|---|
| Cardo-Oncolody Referral | Experimental | Referral to cardio-oncology for guidelines-based personalized cardio-oncology management Receives: Other: Cardio-Oncology Referral |
| PCP/General Cardiology Care | Active comparator | Notification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy Receives: Other: Notification to PCP/General Cardiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 Months Post-Intervention
Secondary outcomes (12)
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
Measured: 6 and 12 Months Post Intervention
Rate of Statin Intervetion
To determine the rate of statin intervention at 3 months
Measured: 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
Measured: 6 and 12 Months Post Intervention
Rate of any CV Medication Intervention
To determine the rate of any CV medication intervention at 6 months
Measured: 6 Months Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (low density lipoprotein [LDL])
Measured: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (systolic blood pressure)
Measured: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (hemoglobin A1c)
Measured: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
To assess changes in biological CV risk factors (body mass index)
Measured: 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)
Measured: 3, 6, and 12 Month Post-Intervention
Rate of new CV or Cardiac Diagnosis
To determine the rate of new CV or cardiac diagnosis
Measured: 3, 6, and 12 Month Post-Intervention
One-Year MACE Rate
To determine the one-year MACE rate
Measured: 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)
Measured: 12 Month Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start15 Jul 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following eligibility verification, randomization will occur in REDCap via the Randomization Module. Patients will be randomized in a 1:1 ratio to (A) cardio-oncology management guidelines-based care vs. (B) notification to their primary care physician and/or general cardiologist of ARPI therapy initiation and recommendation for CV risk optimization (control) using stratified block randomization. Refer to section 10.0 for stratification methodology.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Atkins, Cedars-Sinai Medical Center
- Investigators
- Katelyn Atkins, MD, PhD, Principal investigator, Cedars-Sinai Medical CenterLeslie Ballas, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223385
- Sponsor's protocol ID
- IIT2025-09-BALLAS-ATKINS-HEART
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
- ClinicalTrials.gov ID
- NCT07223385
- Acronym / sponsor ID
- IIT2025-09-BALLAS-ATKINS-HEART
- Keywords
- High-Risk, Lymph-node positive, ARPI Therapy, CV Risk Factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following eligibility verification, randomization will occur in REDCap via the Randomization Module. Patients will be randomized in a 1:1 ratio to (A) cardio-oncology management guidelines-based care vs. (B) notification to their primary care physician and/or general cardiologist of ARPI therapy initiation and recommendation for CV risk optimization (control) using stratified block randomization. Refer to section 10.0 for stratification methodology.
| Arm | Type | Receives |
|---|---|---|
| Cardo-Oncolody Referral | Experimental | Other: Cardio-Oncology ReferralReferral to cardio-oncology for guidelines-based personalized cardio-oncology management |
| PCP/General Cardiology Care | Active comparator | Other: Notification to PCP/General CardiologistNotification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- ECOG 0-2
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (2 listed)
- Prior ARPI therapy exposure > 6 months duration.
- Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-Oncology ReferralReferral to cardio-oncology for guidelines-based personalized cardio-oncology management | Other | Cardo-Oncolody Referral |
| Notification to PCP/General CardiologistNotification to patient's primary care physician and/or general cardiologist and recommendation for CV risk optimization after initiation of ARPI therapy | Other | PCP/General Cardiology Care |
Primary outcome
Rate of any CV medication Initiation and/or Change
Time frame: 3 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)
12 secondary outcomes
The Rate of Compliance with CV Therapeutic Medication Intervention
Time frame: 6 and 12 Months Post Intervention
Rate of Statin Intervetion
Time frame: 3 Months Post Intervention
Rate of Compliance with Statin Medication Intervention
Time frame: 6 and 12 Months Post Intervention
Rate of any CV Medication Intervention
Time frame: 6 Months Post-Intervention
Changes in Biological CV Risk Factor
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Time frame: 3, 6, and 12 Month Post-Intervention
Changes in Biological CV Risk Factor
Time frame: 3, 6, and 12 Month Post-Intervention
Rate of Coronary Artery Disease Testing
Time frame: 3, 6, and 12 Month Post-Intervention
Rate of new CV or Cardiac Diagnosis
Time frame: 3, 6, and 12 Month Post-Intervention
One-Year MACE Rate
Time frame: 12 Months Post-Intervention
Rate of Grade ≥ 2 Cardiac CTCAE
Time frame: 12 Month Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katelyn Atkins, MD, PhD contact
Katelyn Atkins, MD, PhD principal investigator
Cedars-Sinai Medical Center
Leslie Ballas, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardio-Oncology Referral and Notification to PCP/General Cardiologist in people with Prostate Cancer (Diagnosis) and Prostate Cancer Stage IV, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Recruitment Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of any CV medication Initiation and/or Change (time frame: 3 Months Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.