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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Alicia Morgans, MD, MPH
aliciak_morgans@dfci.harvard.edu
857-215-1605
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 180
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: National Comprehensive Cancer Network

This content was sourced from clinicaltrials.gov