Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer (PCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Prostate Cancer; Drug-Related Side Effects and Adverse Reactions; Cardiotoxicity
• Intervention / Treatment: Other: Social Determinants of Health

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Bonnie Ky, MD, MSCE; Phone Number: 215-573-6606; Email: bonnie.ky@pennmedicine.upenn.edu
• Study Contact Backup: Name: Amanda Smith, MA; Email: amanda.smith4@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Bonnie Ky, MD, MSCE, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Social Determinants of Health; Cardio-Oncology; Cardiotoxicity of Chemotherapy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Wounds and Injuries; Genital Neoplasms, Male; Prostatic Diseases; Radiation Injuries; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Cardiovascular Diseases; Prostatic Neoplasms; Drug-Related Side Effects and Adverse Reactions; Cardiotoxicity
• Other Study ID Numbers: UPCC 12821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No