Managing cardiovascular risks in prostate cancer patients starting hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.