ABSTRACT

VACURG study 2, indicated that 1.0 mg/day was as effective as 5 mg/day DES in terms of deaths due to prostate cancer; however, there was a significant decrease in the incidence of severe and potentially fatal cardiovascular complications on the 1.0 mg/day arm. Both 5 mg/day and 1.0 mg/day DES had a lower incidence of deaths due to prostate cancer compared with a dose of 0.2 mg/day of DES or placebo. Unlike VACURG study 1, several patients on the placebo arm never received any treatment at the time of progression, and so study 2 is not perceived as an adequate test of the immediate versus deferred treatment question. Furthermore, VACURG study 2 was designed primarily to address the safety issue.