The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study

August 13, 2025 updated by: Vivek Narayan

The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC): Initial Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation

The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations.

The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer.

The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Abramson Cancer Center of the University of Pennsylvania
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men with prostate cancer > 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of ADT
  • Patients must be able to read and understand English.

Exclusion Criteria: n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Men With Prostate Cancer Planned for Receiving ADT
Men with prostate cancer > 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of systemic androgen deprivation therapy (ADT).
Behavioral: CARE-PC Web-Based Application
The CARE-PC app is a pragmatic, patient-oriented, web-based application that enables the education of patients regarding cardiovascular (CV) risks and collects CV and prostate cancer-related risk variables and CV care access data from prostate cancer patients receiving ADT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CARE-PC Web-Based Application Completion Rate
Time Frame: 18 months
Completion rate measured as the proportion of participants successfully completing the web-based application out of the total number of subjects approached.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptance and perception of the web-based application
Time Frame: 18 months
Acceptance/perception measured by brief embedded survey following participation in the web-based application
18 months
Percent accuracy of patient-derived CV- and prostate cancer-related data elements
Time Frame: 18 months
Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians
18 months
Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation
Time Frame: 18 months
Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians
18 months
Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
Time Frame: 18 months
Patient reported cardiologist involvement via CARE-PC application at time of application survey completion
18 months
Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
Time Frame: 18 months
CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion
18 months
Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.
Time Frame: 18 months
Proportion of participants having changes in CV risk-reducing medications assessed through parallel medical chart review by cardiology and oncology clinicians within 6 months post-application survey completion
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivek Narayan

Collaborators

National Comprehensive Cancer Network

Investigators

  • Principal Investigator: Vivek Narayan, MD, University of Pennsylvania

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 Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 07823
  • 853844 (Other Identifier: University of Pennsylvania IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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