Cardiotoxicity, Cardiovascular Diseases, Drug-Related Side Effects and Adverse Reactions, Prostate Cancer
Conditions
Keywords
Cardiotoxicity of Chemotherapy, Cardio-Oncology, Social Determinants of Health
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.
Interventions
OTHERSocial 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.
Sponsors
Abramson Cancer Center at Penn Medicine
American Heart Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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 Circumferential Strain | through study completion (expected to be 15 years) | Change in circumferential 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 Left Ventricular (LV) Mass | through study completion (expected to be 15 years) | Change in LV Mass 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 Ventricular-Arterial Coupling | through study completion (expected to be 15 years) | Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBonnie Ky, MD, MSCE
University of Pennsylvania
Outcome results
None listed