Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer

Study Overview
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Brief Summary
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This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.

Detailed Description
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The investigators propose a prospective longitudinal cohort of prostate cancer patients treated with Androgen Deprivation Therapy (ADT) to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine wither associations between SDOH and cardiotoxicity risk differs according to race. Patients will be followed with serial echo, blood draw, and surveys prior to start of ADT and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of ADT.

Official Title
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Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy

Conditions
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Prostate Cancer, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases

Intervention / Treatment
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* Other: Social Determinants of Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men older than 18 years of age Prostate cancer diagnosis planned for treatment with ≥6 months of ADT (with or without RT) for clinically localized, biochemically recurrent, or oligometastatic disease. Planned ADT regimens may include: GnRH agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and GnRH antagonists (degarelix). Additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with GnRH agonist/antagonist therapies per provider clinical discretion. Ability to provide informed consent Exclusion Criteria: Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Social Determinants of Health|We will perform detailed phenotyping of Social Determinants of Health using the National Institute of Minority Health and Health Disparities PhenX SDOH toolkit at baseline.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Left Ventricular Ejection Fraction (LVEF) | Absolute change in LVEF by echocardiogram at follow-up | through study completion (expected to be 15 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer therapy-related cardiac dysfunction (CTRCD) | Incidence of CTRCD defined as at least a 10% absolute change in LVEF by echocardiogram at follow-up relative to baseline to a value < 50% | through study completion (expected to be 15 years) | 
| Symptomatic Heart Failure (HF) | Incidence of symptomatic heart failure (centrally adjudicated) | through study completion (expected to be 15 years) | 
| Change in Longitudinal Strain | Change in longitudinal strain by echo from baseline | through study completion (expected to be 15 years) | 
| Change in Circumferential Strain | Change in circumferential strain by echo from baseline | through study completion (expected to be 15 years) | 
| Change in Diastolic function | Change in diastolic function defined as E/e' by echo from baseline | through study completion (expected to be 15 years) | 
| Change in Left Ventricular (LV) Mass | Change in LV Mass by echo from baseline | through study completion (expected to be 15 years) | 
| Change in Relative LV Wall Thickness | Change in relative LV wall thickness from baseline | through study completion (expected to be 15 years) | 
| Change in Ventricular-Arterial Coupling | Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline | through study completion (expected to be 15 years) | 
| Change in LV Twist | Change in LV Twist measured by 3D echo from baseline | through study completion (expected to be 15 years) | 
| Change in LV Torsion | Change in LV Torsion measured by 3D echo from baseline | through study completion (expected to be 15 years) | 
| Change in NTproBNP | Change in NTproBNP measured in batches from banked samples from baseline. | through study completion (expected to be 15 years) | 
| Change in high-sensitivity troponin (hsTnT) | Change in hs-TnT measured in batches from banked samples from baseline. | through study completion (expected to be 15 years) | 
| Change in patient reported fatigue | Change in Patient Reported Outcomes Information System (PROMIS) Fatigue Score from baseline. A higher score corresponds to higher reported levels of fatigue. | through study completion (expected to be 15 years) | 
| Change in patient reported quality of life | Change in Patient Reported Outcomes Information System (PROMIS) Global Health score from baseline. Higher scores indicate a healthier patient. | through study completion (expected to be 15 years) | 
| Change in patient reported activity level | Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline. | through study completion (expected to be 15 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiotoxicity of Chemotherapy, Cardio-Oncology, Social Determinants of Health