The RADICAL PC trial is recruiting consecutive men with a new diagnosis of prostate cancer or commencing ADT for the first time. Patients who do not see a cardiologist annually are then randomized to receive a cardiovascular risk factor intervention, which may include aspirin, a statin, a blood pressure lowering to a target systolic of 130mmHg, and standardized exercise and dietary counseling. Men who are not eligible for randomization (ie see a cardiologist annually) are being followed to provide a representative cohort. The target recruitment goal for this study is at least 6000 men who will then be followed for an average of three years. The primary endpoint for the study is the composite outcome of CV death, myocardial infarction, stroke, heart failure, or arterial revascularization.
In the pilot analysis of RADICAL PC, 421 men from three Canadian sites were included, of which 334 were newly diagnoses prostate cancer patients and 87 patients were receiving ADT for the first time. Among this initial cohort, 56% of men were randomized of which 41% had hypertension, 17% were diabetic, 55% were current or previous smokers, and 81% were overweight or obese. Among the randomized patients, one third are on statins and one third are taking aspirin. For the pilot results, patients who are commencing ADT are older (67 vs. 71 years p<0.001) and have higher prevalence of preexisting coronary artery disease (11% vs. 20% p=0.003) compared to those who are not taking ADT. Limitations of the pilot study include no information regarding the primary outcome at the interim analysis.
As clinicians treating patients with prostate cancer, we are continually evaluating life expectancy, comorbidity score and ultimately trying to decide which patients will benefit from treatment for prostate cancer. As the pilot study results suggest, cardiovascular disease and its risk factors are common in newly diagnosed prostate cancer patients. We eagerly await the final results of this trial, particularly as it pertains to cardiovascular risk and outcomes among patients receiving ADT.
Presented By: Jehonathan Pinthus, McMaster University, Hamilton, ON, Canada
Co-Authors: John Oliver DeLancey, Anuj Desai, Adam Weiner, Edward Schaeffer
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA