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

RECRUITING

I'm interested ...!!

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 🦠 Drug-Related Side Effects and Adverse Reactions 🦠 Cardiovascular Diseases

🗓️ Study Start (Actual) 27 October 2021

🗓️ Primary Completion (Estimated) October 2028

✅ Study Completion (Estimated) October 2028

👥 Enrollment (Estimated) 200

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: MALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 12 October 2021
First Submitted that Met QC Criteria 15 October 2021
First Posted 27 October 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 22 February 2024
Last Update Posted 23 February 2024
Last Verified February 2024