Dr. McGregor on the Goal of the PRONOUNCE Trial in Prostate Cancer

Pei-Chun McGregor, MD, cardio-oncologist and director of Ambulatory Cardiology at VA Boston Healthcare System, instructor in medicine, Brigham and Women’s Hospital, discusses the goal of the phase IIb PRONOUNCE trial in prostate cancer.

This trial is still ongoing, but it is expected to complete within the next year or 2, says McGregor. It's a multicenter, randomized control trial looking specifically at cardiovascular events in patients with prostate cancer and any underlying pre-existing cardiovascular disease.

Investigators are planning to randomize patients to receive a GnRH antagonist, degarelix (Firmagon), versus leuprolide, which is an agonist. The expected enrollment is 900 patients. The primary endpoint is time from randomization to the first major adverse cardiovascular event (MACE). The secondary endpoints will be comprised of individual MACE endpoints, says McGregor. Investigators are also planning to look at biomarkers—specifically, cardiovascular, inflammatory, and immune biomarkers. This will be the first trial to prospectively study this. Hopefully, the trial will answer the question of whether GnRH agonists have a potentially adverse signal toward the cardiovascular system over the antagonists, concludes McGregor.