Overall survival and immune responses with sipuleucel-T and enzalutamide: STRIDE study.

246Background: STRIDE (NCT01981122) is the first study comparing concurrent (con) vs sequential (seq) enzalutamide (enz) with sipuleucel-T (sip-T) in patients (pts) with metastatic castration-resistant prostate cancer. Pts were followed until death or for 3 years. Methods: Fifty-two pts were randomized 1:1 to 3 sip-T infusions and enz started 2 wks before (n = 25, con) or 10 wks after (n = 27, seq) sip-T. Enz was continued for 52 wks or until disease progression (DP)/toxicity. Time to clinical outcomes was estimated by Kaplan-Meier analysis. Results: Median age (years): con 66; seq 72 (p = 0.01). Baseline characteristics and laboratory values were similar between arms. K-M estimated median follow up: 40.2 months. Clinical trial information: NCT01981122. Conclusions: Long-term follow-up suggests sip-T+enz is well-tolerated with no new safety concerns. Though not powered for such, con vs seq rx did not result in differences in OS or DP; differences in PSA responses cannot be excluded. Larger studies could b...