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

NCT05096338 | Active Not Recruiting

• 1 other identifier: UPCC 12821
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiotoxicity of Chemotherapy; Cardio-Oncology; Social Determinants of Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Cancer therapy-related cardiac dysfunction (CTRCD)

  through study completion (expected to be 15 years)

• Symptomatic Heart Failure (HF)

  through study completion (expected to be 15 years)

• Change in Longitudinal Strain

  through study completion (expected to be 15 years)

• Change in Circumferential Strain

  through study completion (expected to be 15 years)

• Change in Diastolic function

  through study completion (expected to be 15 years)

Interventions

Social Determinants of Health OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• American Heart Association: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Barrett M, Wilcox NS, Huang A, Levy R, Demissei B, Narayan V, Ky B. Bearing allostatic load: insights into a more equitable future within cardio-oncology. Trends Mol Med. 2022 Dec;28(12):1040-1049. doi: 10.1016/j.molmed.2022.09.006. Epub 2022 Oct 4.

  PMID: 36207229 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, and buffy coat will be banked.

MeSH Terms

Conditions

Prostatic Neoplasms; Cardiotoxicity; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Diseases

Interventions

Social Determinants of Health

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Health Status; Demography; Population Characteristics; Health

Study Officials

• Bonnie Ky, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 27, 2021
• Study Start: October 27, 2021
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)