Clinical trial NCT05096338: Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer
Official title: Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated with Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Cardiotoxicity
Drug-Related Side Effects and Adverse Reactions
Cardiovascular Diseases
Keywords: Cardiotoxicity of Chemotherapy
Cardio-Oncology
Social Determinants of Health
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2021-10-27
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the medical oncology practices at the Abramson Cancer Center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: through study completion (expected to be 15 years)
Secondary outcomes:
measure: Cancer therapy-related cardiac dysfunction (CTRCD)
timeFrame: through study completion (expected to be 15 years)
measure: Symptomatic Heart Failure (HF)
timeFrame: through study completion (expected to be 15 years)
measure: Change in Longitudinal Strain
timeFrame: through study completion (expected to be 15 years)
measure: Change in Circumferential Strain
timeFrame: through study completion (expected to be 15 years)
measure: Change in Diastolic function
timeFrame: through study completion (expected to be 15 years)
measure: Change in Left Ventricular (LV) Mass
timeFrame: through study completion (expected to be 15 years)
measure: Change in Relative LV Wall Thickness
timeFrame: through study completion (expected to be 15 years)
measure: Change in Ventricular-Arterial Coupling
timeFrame: through study completion (expected to be 15 years)
measure: Change in LV Twist
timeFrame: through study completion (expected to be 15 years)
measure: Change in LV Torsion
timeFrame: through study completion (expected to be 15 years)
measure: Change in NTproBNP
timeFrame: through study completion (expected to be 15 years)
measure: Change in high-sensitivity troponin (hsTnT)
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported fatigue
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported quality of life
timeFrame: through study completion (expected to be 15 years)
measure: Change in patient reported activity level
timeFrame: through study completion (expected to be 15 years)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Bonnie Ky, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: