Introduction

Administrative registries suggest that cardiovascular (CV) disease develops frequently in men with prostate cancer (PC). Known CV risk factors, such as hypertension, dyslipidemia, and obesity may account for some of the risk, however PC-specific factors, including androgen deprivation therapy (ADT) may also play a role. The goals of RADICAL PC are to identify the incidence and major determinants of CV disease, and to evaluate whether systematic CV risk factor modification reduces adverse CV events in men with PC. We report the findings for the pilot phase of this study.

Methods

RADICAL PC recruits consecutive men with a new diagnosis of PC or commencing ADT for the 1st time. Those who do not see a cardiologist annually are randomized in an open manner to receive a CV risk factor intervention (aspirin, statin, blood pressure-lowering to a target systolic of 130mmHg, and standardized exercise and dietary counseling). Those not eligible for randomization are followed to provide a representative sample. At least 6000 men will be recruited and followed for an average of 3 years. Renal function, lipids, and HbA1c will be measured serially. The primary endpoint is the composite of CV death, myocardial infarction, stroke, heart failure, or arterial revascularization. Fisher’s exact test and ANOVA test were used for categorical and normally distributed continuous variables comparisons respectively.

Results

The characteristics of the first 421 participants, from 3 Canadian sites, are presented. Of these, 334 were newly diagnosed and 87 were receiving ADT for the 1st time, 25 had metastatic disease and 62 were undergoing radiotherapy. Of all participants, 56% have been randomized, and the remainders are undergoing passive follow up. 41% of the patients had hypertension and of the 246 participants with no known hypertension, additional 31% had blood pressure in the hypertensive range. 17% of the patients are diabetic, 55% are current or previous smokers and 81% are overweight (45%) or obese (36%). A third of the patients are on statins and a third take ASA. Patients who are commencing on ADT are older (67+/-8.4 vs. 71+/-8.3 years p<0.0001) and have higher prevalence of preexisting coronary artery disease (11% vs. 20% p=0.003) compared to those who have no indication for ADT.

Conclusions

Pre-established cardiovascular disease and its risk factors are very common in newly diagnosed prostate cancer patients. The baseline characteristics of patients who are planned to initiate ADT may place them in a higher CVS risk compared to the general PC patient population.

Funding

PROSTATE CANCER CANADA_x000D_ Hamilton Health Sciences RFA strategic initiative