Prostate CancerNCT06064149
The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study
A study testing CARE-PC Web-Based Application in people with Prostate Cancer, run by Vivek Narayan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CARE-PC Web-Based Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 1 Jan 2027
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- CARE-PC Web-Based Application
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARE-PC Web-Based ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: CARE-PC Web-Based Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (6)
Patient acceptance and perception of the web-based application
Acceptance/perception measured by brief embedded survey following participation in the web-based application
Measured: 18 months
Percent accuracy of patient-derived CV- and prostate cancer-related data elements
Accuracy assessed through parallel medical chart review by cardiology and oncology clinicians
Measured: 18 months
Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation
Prevalence assessed through parallel medical chart review by cardiology and oncology clinicians
Measured: 18 months
Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
Patient reported cardiologist involvement via CARE-PC application at time of application survey completion
Measured: 18 months
Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
CV care engagement assessed through medical chart review by investigators within 6 months post-application survey completion
Measured: 18 months
Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start14 Nov 2023
- Primary completion10 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Narayan
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Sponsor-investigator, Vivek Narayan, Abramson Cancer Center at Penn Medicine
- Investigators
- Vivek Narayan, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064149
- Sponsor's protocol ID
- UPCC 07823
- Other IDs
- 853844
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC): Initial Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation
- ClinicalTrials.gov ID
- NCT06064149
- Acronym / sponsor ID
- UPCC 07823
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vivek NarayanUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men With Prostate Cancer Planned for Receiving ADT | Other | Behavioral: CARE-PC Web-Based ApplicationMen 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARE-PC Web-Based ApplicationThe 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. | Behavioural | Men With Prostate Cancer Planned for Receiving ADT |
Primary outcome
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.
6 secondary outcomes
Patient acceptance and perception of the web-based application
Time frame: 18 months
Percent accuracy of patient-derived CV- and prostate cancer-related data elements
Time frame: 18 months
Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation
Time frame: 18 months
Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
Time frame: 18 months
Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
Time frame: 18 months
Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Narayan, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARE-PC Web-Based Application in people with Prostate Cancer, run by Vivek Narayan 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 0 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 25 Sep 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?
CARE-PC Web-Based Application Completion Rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.