NCT06064149

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
2mo left

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Nov 2023Aug 2026

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

September 26, 2023

Last Update Submit

August 13, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • CARE-PC Web-Based Application Completion Rate

    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 Outcomes (6)

  • Patient acceptance and perception of the web-based application

    18 months

  • Percent accuracy of patient-derived CV- and prostate cancer-related data elements

    18 months

  • Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation

    18 months

  • Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation

    18 months

  • Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation

    18 months

  • +1 more secondary outcomes

Study Arms (1)

Men With Prostate Cancer Planned for Receiving ADT

OTHER

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

Interventions

CARE-PC Web-Based ApplicationBEHAVIORAL

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.

Men With Prostate Cancer Planned for Receiving ADT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Vivek Narayan, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Doyle

CONTACT

610-357-6354matthew.doyle@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

November 14, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations

US(1)