Randomized phase 2 therapeutic equivalence study of abiraterone acetate fine particle formulation vs. originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer: The STAAR study.

Cy A Stein,Richard Levin,Robert Given,Celestia S Higano,Paul Nemeth,Bill Bosch, Jillian Chapas-Reed,Robert Dreicer

Urologic Oncology: Seminars and Original Investigations（2018）

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摘要

•AAFP 500mg is therapeutically equivalent to OAA 1000mg.•Therapeutic equivalence was based on testosterone suppression.•AAFP produced similar prostate-specific antigen-50 response rates as OAA.•AAFP offered a comparable safety profile to OAA.•Abiraterone trough levels were similar between AAFP and OAA.

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关键词

Abiraterone,Testosterone,Prostate-specific antigen,CYP17 inhibitor,Metastatic castrate-resistant prostate cancer

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