Status:
RECRUITING
CV CARE: CardioVascular Care in PC Patients
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Prostate Cancer
Cardiovascular Diseases
Eligibility:
MALE
18+ years
Phase:
NA
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 th...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06202820
Start Date
January 18 2024
End Date
December 31 2026
Last Update
August 11 2025
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215