Recruiting

CardioVascular CareCV CARE: CardioVascular Care in PC Patients

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06202820

Conditions

Prostate Cancer

Cardiovascular Diseases

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CV Care Program

Study Details

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)

Conditions

Prostate Cancer

Cardiovascular Diseases

Study ID

NCT06202820

Start date

Jan 18, 2024

Status verified date

Aug, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

Primary outcome measure

Participant Retention Rate in CV CARE 2 [ Time Frame: Weeks 4 and 24 in CV CARE 2 ]

Central Contacts and Locations

Central contacts

Alicia Morgans, MD, MPH

857-215-1605 aliciak_morgans@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alicia Morgans, MD, MPH

857-215-1605 aliciak_morgans@dfci.harvard.edu

Principal Investigator:

Alicia Morgans, MD, MPH

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alicia Morgans, MD, MPH

857-215-1605 aliciak_morgans@dfci.harvard.edu

Principal Investigator:

Alicia Morgans, MD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jun 29, 2026

Last verified

Aug, 2025

Keywords

Prostate Cancer
Cardiovascular Diseases
Cardiovascular Risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-06-29.