Clinical trial NCT06202820: CV CARE: CardioVascular Care in PC Patients
Official title: CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Cardiovascular Diseases
Keywords: Prostate Cancer
Cardiovascular Diseases
Cardiovascular Risk
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2024-01-12
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Retention Rate in CV CARE 2
timeFrame: Weeks 4 and 24 in CV CARE 2
Secondary outcomes:
measure: Proportion of Participants on Statin Medications in CV CARE
timeFrame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
measure: Proportion of Participants on Statin Medications in CV CARE 2
timeFrame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
measure: Proportion of Participants on Blood Pressure Medications in CV CARE
timeFrame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
measure: Proportion of Participants on Blood Pressure Medications in CV CARE 2
timeFrame: 5 months (From 4 weeks after ADT initiation to the week 24 on-treatment visit)
measure: Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE
timeFrame: 6 months (From the ADT initiation to the week 24 on-treatment visit)
measure: Proportion of Participants with Blood Pressure Below 130/85 (mmHg) in CV CARE 2
timeFrame: 6 months (From the ADT initiation to the week 24 on-treatment visit)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alicia Morgans, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: