CV CARE: CardioVascular Care in PC Patients

NCT06202820 | Recruiting

• 1 other identifier: 23-311
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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

Keywords

Prostate Cancer; Cardiovascular Diseases; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Participant Retention Rate in CV CARE 2

  The percentage of a continued participation rate at week 24 of participants who participate at week 4 in the revised iteration of the program (CV CARE 2).

  Weeks 4 and 24 in CV CARE 2

Secondary Outcomes (6)

• Proportion of Participants on Statin Medications in CV CARE

  5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

• Proportion of Participants on Statin Medications in CV CARE 2

  5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

• Proportion of Participants on Blood Pressure Medications in CV CARE

  5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

• Proportion of Participants on Blood Pressure Medications in CV CARE 2

  5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)

• Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE

  6 months (From the ADT initiation to the week 24 on-treatment visit)

Study Arms (2)

CV Care Program

EXPERIMENTAL

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.

Behavioral: CV Care Program

CV Care Program 2

EXPERIMENTAL

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.

Behavioral: CV Care Program

Interventions

CV Care Program 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; CV Care Program 2

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alicia Morgans, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Morgans, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 12, 2024
• Study Start: January 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)