Randomised phase 3 trial of enzalutamide in first-line androgen deprivation therapy for metastatic prostate cancer: The ANZUP ENZAMET Trial (ANZUP 1304).

TPS5090Background: Androgen deprivation therapy (ADT) is widely used as initial treatment for hormone-naive, metastatic prostate cancer (PC). Meta-analysis of RCTs showed a 3% absolute improvement in 5 year survival with the addition of non-steroidal anti androgen (NSAA) to ADT. Residual, low level androgen receptor (AR) signalling or agonist activity from conventional NSAA may provide a stimulatory signal to hormone-sensitive PC cells. We hypothesize that the early use of enzalutamide, a more potent and effective AR blocker, will reduce residual AR signalling and improve survival. The aim is to determine whether ADT + enzalutamide improves overall survival (OS) compared to ADT + conventional NSAA in M1 castrate-naive PC. Methods: DESIGN: open label, randomised, phase 3 trial including ANZ, Canada, UK, Ireland and USA. ELIGIBILITY: metastatic PC starting first line ADT. STRATIFICATION: volume of disease, anti-resorptive therapy, comorbidities, planned early docetaxel use, study site. ENDPOINTS: OS (primar...