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

Active, not recruiting

• Conditions: Cardiotoxicity; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Diseases; Prostate Cancer

• Registration Number: NCT05096338
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-15
• Study Start: 2021-10-27
• Study First Posted: 2021-10-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2029-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular Ejection Fraction (LVEF)	through study completion (expected to be 15 years)	Absolute change in LVEF by echocardiogram at follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States