Enzalutamida. Desarrollo futuro - page 8

PROSPER: An efficacy and safety study of enzalutamide in
patients with non-metastatic CRPC
Ongoing trials
PROSPER is a multinational,
Planned evaluations
Phase 3, randomised, double‐blind, 
placebo‐controlled trial
Primary endpoint: Metastasis‐free survival
Metastasis‐free survival
OS
Time to pain progression
Enzalutamide
n=1560
Non‐metastatic (M0) 
Time to opiate use for prostate 
cancer pain
Time to first use of cytotoxic 
h th
160 mg QD
R
2:1
CRPC
Testosterone 
≤50 ng/dL
c emo erapy
Time to first use of new 
antineoplastic therapy
Time to PSA progression
Placebo 
QD
Progressive disease 
with ongoing ADT
Asymptomatic
PSA response rates
QoL
PSADT ≤10 months
Recruiting
Timing
Estimated study completion 
August 2017
ADT=androgen‐deprivation therapy; CRPC=castration‐resistant prostate cancer; OS=overall survival; PSA=prostate‐specific antigen; 
PSADT=PSA doubling time; QD=once daily; QoL=quality of life; R=randomisation.
NCT02003924. Available at
Last accessed: July 2016.
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