Managing cardiovascular risks in prostate cancer patients starting hormone therapy
CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients
This study is testing a program to help men with prostate cancer manage heart health risks when they start hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06202820 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate a program designed to assess and manage reversible cardiovascular risk factors in patients with prostate cancer who are beginning androgen deprivation therapy (ADT). The study will integrate a standardized method into the clinics at Dana-Farber Cancer Institute to ensure comprehensive cardiovascular care for these patients. Participants will undergo screening for eligibility, treatment visits, and various assessments including questionnaires, blood tests, and urine tests over a period of approximately six months. The study is expected to enroll between 60 to 150 participants.
Who should consider this trial
Good fit: Ideal candidates include men with a histologic diagnosis of prostate adenocarcinoma who are recommended to start at least 24 weeks of ADT.
Not a fit: Patients who are not diagnosed with prostate cancer or those not starting ADT may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve cardiovascular health outcomes for prostate cancer patients undergoing ADT.
How similar studies have performed: Other studies have shown success in managing cardiovascular risks in cancer patients, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Alicia Morgans, MD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Alicia Morgans, MD, MPH
- Email: aliciak_morgans@dfci.harvard.edu
- Phone: 857-215-1605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.