NCT06202820Recruiting
CV CARE: CardioVascular Care in PC Patients
CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 1 Jan 2024
- Start date
- 18 Jan 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06202820
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 18 Jan 2024 to the primary completion date, 1 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.