RECRUITING

CV CARE: CardioVascular Care in PC Patients

Conditions

Prostate Cancer Cardiovascular Diseases Cardiovascular Risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. The name of the intervention used in this research study is: CV Care (cardiovascular risk assessment and management program)

Official Title

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

Quick Facts

Study Start:2024-01-18

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06202820

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Alicia Morgans, MD, MPH

CONTACT

857-215-1605

aliciak_morgans@dfci.harvard.edu

Principal Investigator

Alicia Morgans, MD, MPH

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Alicia Morgans, MD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-18

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-01-18

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Cardiovascular Diseases
Cardiovascular Risk

Additional Relevant MeSH Terms

Prostate Cancer
Cardiovascular Diseases