High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether early care from a heart doctor who works with cancer patients can lower heart and blood vessel risks during ARPI treatment, which blocks male hormone signals. It is for people with prostate cancer who have heart risk factors. The study also looks at blood cell changes and how the body uses nutrients to help predict heart risk.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have prostate cancer that is localized (in the prostate), very high risk, in nearby lymph nodes, and/or metastatic (stage IV, spread to other parts of the body).
- Be taking ARPI treatment, with plans to take it for at least 18 months.
- Be older than 65 with at least 1 listed heart risk factor, or age 45–65 with at least 2.
- Listed risk factors include high blood pressure, high cholesterol, or diabetes.
- Other listed risk factors include calcium buildup in heart arteries seen on a chest CT scan, or early heart artery disease in a father or brother before age 55, or a mother or sister before age 65.
- Have an ECOG activity score of 0–2: be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- Sign a consent form and be able to follow the study requirements.
Who can't join
- Have already taken ARPI treatment for more than 6 months.
- Already receive care from a cardio-oncologist, a heart doctor who specializes in heart risks from cancer and cancer treatments.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
CA
- Cedars Sinai Medical Center · Los Angeles, CA 90048Clinical Trial Recruitment Navigator · Study contact · 13104232133 · GroupCancerTrialInformation@cshs.orgKatelyn Atkins, MD, PhD · Principal investigatorLeslie Ballas, MD · Principal investigatorMore trials in Los Angeles