This trial tests the feasibility of a personalized cardiovascular counseling in managing reversible cardiovascular risk factors for patients receiving androgen deprivation therapy (ADT) for prostate adenocarcinoma. Androgen deprivation therapy is effective in disease control for men with prostate cancer but also can increase the risk for cardiovascular complications. Providing personalized cardiovascular counseling may help to better manage reversible cardiovascular risk factors in men receiving ADT for prostate adenocarcinoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06202820.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Alicia Katherine Morgans
Phone: 857-215-1605
Dana-Farber Cancer InstituteStatus: Active
Contact: Alicia Katherine Morgans
Phone: 857-215-1605
PRIMARY OBJECTIVE:
I. To determine the feasibility of integrating the revised cardiovascular care of androgen related effects (CV CARE) program (CV CARE 2) into the genitourinary (GU) Oncology care workflow at Dana-Farber Cancer Institute (DFCI).
SECONDARY OBJECTIVES:
I. To quantify the proportion of patients that start or adjust statin medications between 4 weeks after androgen deprivation therapy (ADT) initiation and the week 24 on-treatment visit among those who are with atherosclerotic cardiovascular disease (ASCVD) risk score > 10% and 20% at week 4.
II. To quantify the proportion of patients that start or adjust blood pressure medications between week 4 after ADT initiation and week 24 on-treatment visit among those who are with ASCVD risk score > 10% and 20% at week 4.
III. To compare the proportion of patients with average blood pressure below 130/85 after their participation in the program (average of weeks 12 and 24) to their average blood pressure before the program (average of ADT initiation and week 4).
IV. To assess prostate cancer patient reported satisfaction with CV CARE visit location and duration, and clinician communication of CV risk factors.
V. To assess clinician reported satisfaction with frequency of engagement with local CV care teams, referrals to cardio-oncology, and CV CARE visit duration and location.
EXPLORATORY OBJECTIVES:
I. To determine proportion and degree of aortic atherosclerotic burden identified in clinically obtained computed tomography imaging (if available).
II. To identify sociodemographic and clinical characteristics of patients with aortic atherosclerotic burden identified in clinically obtained computed tomography imaging (if available).
III. To assess the change in aortic atherosclerotic burden between pre-treatment and follow up scan on clinically obtained computed tomography imaging (if available).
OUTLINE: Patients are assigned to 1 of 2 groups.
CV CARE: Patients receive standard of care (SOC) ADT and personalized cardiovascular assessments and counseling including reviewing risk factors and recommending any appropriate medication changes at SOC follow up visits at 4 and 24 weeks.
CV CARE2: Patients receive SOC ADT and updated personalized cardiovascular assessments and counseling including reviewing risk factors and recommending any appropriate medication changes at SOC follow up visits at 4 and 24 weeks.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAlicia Katherine Morgans