CV CARE: CardioVascular Care in PC Patients

Launched by DANA-FARBER CANCER INSTITUTE · Jan 1, 2024

Keywords

ClinConnect Summary

The CV CARE trial is studying a program designed to help manage heart health for men with prostate cancer who are starting a specific treatment called androgen deprivation therapy (ADT). The goal is to identify and address any heart-related risks that can be improved, making sure that all patients receive the best possible care at Dana-Farber Cancer Institute. If you are a man aged 18 or older with a confirmed diagnosis of prostate cancer, and your doctor recommends at least 24 weeks of ADT, you may be eligible to participate in this study.

Participants will take part in two visits 12 and 24 weeks after starting ADT, where they will undergo assessments like blood pressure checks and lab tests. You don’t need to have heart disease to join, but if you do, that’s okay too! This study is looking for men who are willing to work closely with their healthcare team to keep track of their heart health while undergoing cancer treatment. It's important to note that those with certain recent heart issues or those on specific other treatments may not qualify to ensure everyone’s safety during the trial.

Gender

MALE

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.