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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05096338
Other study ID # UPCC 12821
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 27, 2021
Est. completion date October 2028

Study information

Verified date February 2024
Source Abramson Cancer Center at Penn Medicine
Contact Bonnie Ky, MD, MSCE
Phone 215-573-6606
Email bonnie.ky@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2028
Est. primary completion date October 2028
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary Symptomatic Heart Failure (HF) Incidence of symptomatic heart failure (centrally adjudicated) through study completion (expected to be 15 years)
Secondary Change in Longitudinal Strain Change in longitudinal strain by echo from baseline through study completion (expected to be 15 years)
Secondary Change in Circumferential Strain Change in circumferential strain by echo from baseline through study completion (expected to be 15 years)
Secondary Change in Diastolic function Change in diastolic function defined as E/e' by echo from baseline through study completion (expected to be 15 years)
Secondary Change in Left Ventricular (LV) Mass Change in LV Mass by echo from baseline through study completion (expected to be 15 years)
Secondary Change in Relative LV Wall Thickness Change in relative LV wall thickness from baseline through study completion (expected to be 15 years)
Secondary 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)
Secondary Change in LV Twist Change in LV Twist measured by 3D echo from baseline through study completion (expected to be 15 years)
Secondary Change in LV Torsion Change in LV Torsion measured by 3D echo from baseline through study completion (expected to be 15 years)
Secondary Change in NTproBNP Change in NTproBNP measured in batches from banked samples from baseline. through study completion (expected to be 15 years)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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