CV CARE: CardioVascular Care in PC Patients

NCT ID: NCT06202820

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2026-12-31

Brief Summary

This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.

The name of the intervention used in this research study is:

CV Care (cardiovascular risk assessment and management program)

Detailed Description

This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.

Study procedures including screening for eligibility, treatment visits, questionnaires and surveys, and blood and urine tests.

Participation in this research study is expected to last about 6 months.

It is expected that about 60-150 people will take part in this study.

This study is supported by the National Comprehensive Cancer Network (NCCN) through grant funding provided by Pfizer Myovant.

Conditions

Prostate Cancer; Cardiovascular Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CV Care Program

Study procedures will be conducted as follows:

• Standard of care androgen deprivation therapy.
• 4 week standard-of-care follow up visit in clinic with CV care education module completion.
• 12-week standard-of-care prostate cancer care visit with oncologist.
• 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
• The CV Care program will be revised through participant feedback from assessments, surveys, focus groups, and exit-interviews. The revised CV Care Program will be used in the next cohort.

Group Type: EXPERIMENTAL

CV Care Program

Intervention Type: BEHAVIORAL

Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

CV Care Program 2

Study procedures will be conducted as follows:

• Standard of care androgen deprivation therapy.
• 4 week standard-of-care follow up visit in clinic with CV care education module completion.
• 12-week standard-of-care prostate cancer care visit with oncologist.
• 24-week standard-of-care post-ADT visit in clinic with CV Care module completion, surveys, and exit interview with clinical team members.
• Participant feedback from surveys, exit-interviews, and possibly focus groups will be collected.

Group Type: EXPERIMENTAL

CV Care Program

Intervention Type: BEHAVIORAL

Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

Interventions

CV Care Program

Comprised of two, in-clinic, counseling sessions with oncology nurse practitioner or physician assistant for education on cardiovascular disease (CVD) and cardiovascular risk factors as well as recommendations for management.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.
• Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.
• Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.
• Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.
• Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.
• Participants can have pre-existing CVD and/or CV risk factors, but this is not a requirement for inclusion.
• Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.
• Age ≥18 years.
• Life expectancy of greater than 6 months.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.
• Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.
• Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.
• Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Alicia Morgans

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alicia Morgans, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alicia Morgans, MD, MPH

Role: CONTACT

aliciak_morgans@dfci.harvard.edu

857-215-1605

Facility Contacts

Alicia Morgans, MD, MPH

Role: primary

aliciak_morgans@dfci.harvard.edu

857-215-1605

Alicia Morgans, MD, MPH

Role: primary

aliciak_morgans@dfci.harvard.edu

857-215-1605

Other Identifiers

23-311

Identifier Type: -

Identifier Source: org_study_id