CV CARE: CardioVascular Care in PC Patients

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Participant Retention Rate in CV CARE 2 [Time frame: Weeks 4 and 24 in CV CARE 2]

Secondary outcome measures (6)

• Proportion of Participants on Statin Medications in CV CARE [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 6 months (From the ADT initiation to the week 24 on-treatment visit)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• Brigham and Women's Hospital — Boston
• Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT06202820 · 23-311

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗