CV CARE: CardioVascular Care in PC Patients

CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients

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)

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Prostate Cancer
• Intervention / Treatment: Behavioral: CV Care 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alicia Morgans, MD, MPH; Phone Number: 857-215-1605; Email: aliciak_morgans@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Alicia Morgans, MD, MPH; Phone Number: 857-215-1605; Email: aliciak_morgans@dfci.harvard.edu
      • Principal Investigator: Alicia Morgans, MD, MPH
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Alicia Morgans, MD, MPH; Phone Number: 857-215-1605; Email: aliciak_morgans@dfci.harvard.edu
      • Principal Investigator: Alicia Morgans, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants on Statin Medications in CV CARE	The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	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	The percentage of participants who initiate or adjust statin medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	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	The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	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	The percentage of participants who initiate or adjust blood pressure medication usage during the period between 4 weeks after ADT initiation and the week 24 on-treatment visit among individuals with ASCVD risk scores exceeding 10% and 20% at week 4 of the study.	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	The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.	6 months (From the ADT initiation to the week 24 on-treatment visit)
Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2	The comparison of proportion of participants with a blood pressure below 130/85 mmHg between the average blood pressure levels of weeks 12 and 24 of the program and the average blood pressure levels of ADT initiation and week 4.	6 months (From the ADT initiation to the week 24 on-treatment visit)

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Alicia Morgans, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Prostate Cancer; Cardiovascular Risk
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Cardiovascular Diseases
• Other Study ID Numbers: 23-311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No