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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-27

Study Completion Date

2029-11-30

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

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