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Prostate CancerPCTNCT05096338

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

An observational study of Prostate Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Social Determinants of Health
How many people
200 participants
Where
1 siteUnited States
Study dates
27 Oct 2021to Nov 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Cardiotoxicity of Prostate Cancer Therapy: Mechanisms, Predictors, and Social Determinants of Health in Prostate Cancer Patients Treated With Androgen Deprivation Therapy

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.

Read the 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.

Being tested
Social Determinants of Health
Keywords
Cardiotoxicity of Chemotherapy, Cardio-Oncology, Social Determinants of Health
Medical subject headings
Prostatic Neoplasms, Cardiotoxicity, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Determinants of HealthOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Left Ventricular Ejection Fraction (LVEF)

    Absolute change in LVEF by echocardiogram at follow-up

    Measured: through study completion (expected to be 15 years)

Secondary outcomes (15)

  1. 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%

    Measured: through study completion (expected to be 15 years)

  2. Symptomatic Heart Failure (HF)

    Incidence of symptomatic heart failure (centrally adjudicated)

    Measured: through study completion (expected to be 15 years)

  3. Change in Longitudinal Strain

    Change in longitudinal strain by echo from baseline

    Measured: through study completion (expected to be 15 years)

  4. Change in Circumferential Strain

    Change in circumferential strain by echo from baseline

    Measured: through study completion (expected to be 15 years)

  5. Change in Diastolic function

    Change in diastolic function defined as E/e' by echo from baseline

    Measured: through study completion (expected to be 15 years)

  6. Change in Left Ventricular (LV) Mass

    Change in LV Mass by echo from baseline

    Measured: through study completion (expected to be 15 years)

  7. Change in Relative LV Wall Thickness

    Change in relative LV wall thickness from baseline

    Measured: through study completion (expected to be 15 years)

  8. Change in Ventricular-Arterial Coupling

    Change in Ventricular-Arterial Coupling defined as Ea/Ees by echo from baseline

    Measured: through study completion (expected to be 15 years)

  9. Change in LV Twist

    Change in LV Twist measured by 3D echo from baseline

    Measured: through study completion (expected to be 15 years)

  10. Change in LV Torsion

    Change in LV Torsion measured by 3D echo from baseline

    Measured: through study completion (expected to be 15 years)

  11. Change in NTproBNP

    Change in NTproBNP measured in batches from banked samples from baseline.

    Measured: through study completion (expected to be 15 years)

  12. Change in high-sensitivity troponin (hsTnT)

    Change in hs-TnT measured in batches from banked samples from baseline.

    Measured: through study completion (expected to be 15 years)

  13. 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.

    Measured: through study completion (expected to be 15 years)

  14. 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.

    Measured: through study completion (expected to be 15 years)

  15. Change in patient reported activity level

    Change in total weekly leisure activity in METS assessed by Godin Leisure Time Exercise Questionnaire from baseline.

    Measured: through study completion (expected to be 15 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start27 Oct 2021
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096338
Sponsor's protocol ID
UPCC 12821
Acronym
PCT
Status last verified
Mar 2026
First submitted
12 Oct 2021
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36207229

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Cardiotoxicity, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Left Ventricular Ejection Fraction (LVEF) (time frame: through study completion (expected to be 15 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096338, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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