Cardio-Oncology Consultation for Prostate Cancer

Overseen By Clinical Trial Recruitment Navigator

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must be taking: ARPI therapy

Disqualifiers: Prior ARPI > 6 months, Cardio-oncologist care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early heart-focused care can reduce heart risks for patients with prostate cancer. It targets men undergoing hormone therapy (ARPI) who have heart risk factors such as high blood pressure, high cholesterol, or a family history of early heart disease. Participants will receive either specialized heart care through a Cardio-Oncology Consultation or standard heart advice. The study seeks to find better ways to protect the heart while treating prostate cancer. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that patients with prostate cancer who receive androgen deprivation therapy (ADT) face a higher risk of heart problems, including high blood pressure and other heart-related issues. Studies have found that these patients often do not receive optimal care for managing these heart risks.

The safety of the cardio-oncology consultation as a treatment relies on current methods for handling these risks. Previous studies indicate that following heart health guidelines can potentially reduce heart risk for patients. While researchers continue to study this approach, it is grounded in proven heart care strategies that are safe and effective.

In summary, the cardio-oncology consultation aims to improve heart health management in prostate cancer patients. This method is based on established healthcare practices, which have been shown to be safe and helpful in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of a Cardio-Oncology Consultation for prostate cancer patients starting androgen receptor pathway inhibitor (ARPI) therapy. Unlike standard care, which typically involves referrals to a primary care physician or general cardiologist for cardiovascular risk management, this approach provides personalized, guidelines-based cardio-oncology support. This tailored consultation aims to optimize cardiovascular health specifically in the context of cancer treatment, potentially improving overall outcomes for patients by addressing both their cancer and heart health more effectively.

What evidence suggests that this trial's treatments could be effective for reducing cardiovascular risk in prostate cancer patients?

Research has shown that people with prostate cancer often face higher risks for heart problems. Androgen deprivation therapy, a common treatment for prostate cancer, can worsen heart health by raising bad cholesterol and affecting blood sugar. Studies have found that actively managing heart health can lower these risks. For instance, taking statins, which lower cholesterol, has reduced the chances of heart attacks and heart-related deaths. This trial will compare two approaches: one group will receive a referral to cardio-oncology for guidelines-based personalized cardio-oncology management, while another group will have their primary care physician and/or general cardiologist notified with recommendations for cardiovascular risk optimization after initiation of ARPI therapy. Starting heart health plans early, tailored to the individual, may help manage these risks better. ^{1 2 3 6}

Who Is on the Research Team?

Katelyn Atkins, MD, PhD

Principal Investigator

Cedars-Sinai Medical Center

Leslie Ballas, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for men over 65 with prostate cancer and at least one cardiovascular risk factor, or those aged 45-65 with two such factors. They must be starting ARPI therapy for their cancer and able to follow the study's procedures. Men already under a cardio-oncologist's care or who have had more than six months of ARPI therapy are excluded.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

My prostate cancer is at a very high risk stage, may have spread to lymph nodes, or is metastatic.

I am undergoing ARPI therapy for at least 18 months.

Exclusion Criteria

Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies)

I have been treated with ARPI therapy for more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardio-Oncology Intervention

Participants receive early cardio-oncology intervention with guidelines-based CV optimization during ARPI therapy

3 months

Regular visits as per cardio-oncology consultation

Follow-up

Participants are monitored for safety and effectiveness after intervention, including CV medication initiation and changes

12 months

Follow-up assessments at 3, 6, and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Cardio-Oncology Consultation

Trial Overview The trial studies whether early intervention by a heart specialist in men receiving ARPI therapy for prostate cancer can reduce heart disease risks. It will also explore if genetic changes (CHIP) and metabolic signals can predict these risks better.

How Is the Trial Designed?

Group I: Cardo-Oncolody Referral Experimental Treatment 1 Intervention

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

Group II: PCP/General Cardiology Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223385

High Cardiovascular Risk Intervention With Cardio ... In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211357/

Cardio-oncology in advanced prostate cancer - PMC Treatment intensification with androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPi) have led to improved survival in advanced ...

3. jacc.org jacc.org/doi/10.1016/j.jaccao.2024.09.012

Cardiovascular Risk in Prostate Cancer Cardiovascular disease is common in patients with prostate cancer and is a significant cause of death. Cardiovascular risk factors are frequent in this ...

4. cardiooncologyjournal.biomedcentral.com cardiooncologyjournal.biomedcentral.com/articles/10.1186/s40959-025-00318-5

Addressing cardiovascular risks with a goal to prevent ... Androgen deprivation therapy (ADT) is a hallmark treatment for prostate cancer but is associated with the development or exacerbation of cardiovascular disease.

5. cardiooncologyjournal.biomedcentral.com cardiooncologyjournal.biomedcentral.com/articles/10.1186/s40959-023-00186-x

Cardiometabolic healthcare for men with prostate cancer Men diagnosed with prostate cancer are at risk for competing morbidity and mortality due to cardiometabolic disease given their advanced age at diagnosis.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666087324003569

Cardiovascular Risk in Prostate Cancer: JACC Patients with PC are at an elevated risk of CVD and cardiovascular mortality. Cardiovascular risk factors are worsened by ADT.