A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia

Ye D 1 , Huang Y 2 , Zhou F 3 , Xie K 4 , Matveev V 5 , Li C 6 Show all authors , Alexeev B 7 , Tian Y 8 , Qiu M 9 , Li H 10 , Zhou T 11 , De Porre P 12 , Yu M 13 , Naini V 13 , Liang H 14 , Wu Z 14 , Sun Y 11

Affiliations 

  • 1 Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China
  • 2 Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 3 Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
  • 4 Guangzhou First Municipal People's Hospital, Guangzhou, Guangdong, China
  • 5 Department of Urology, Russian Academy of Medical Sciences, Moscow, Russia
  • 6 Department of Urology, Cancer Institute (Hospital), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China
  • 7 Department of Oncology, Moscow Oncology Research Institute, Moscow, Russia
  • 8 Department of Stomatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
  • 9 Department of Urology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
  • 10 Department of Oncology, Peking Union Medical College Hospital, Beijing, China
  • 11 Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China
  • 12 Department of Oncology, Janssen Research & Development, Beerse, Belgium
  • 13 Department of Medical Oncology, Janssen Research & Development, San Diego, CA, USA
  • 14 Department of Urology, Janssen Research & Development, Beijing, China
Asian J Urol, 2017 Apr;4(2):75-85.
PMID: 29264210 DOI: 10.1016/j.ajur.2017.01.002

Abstract

Objective: This double-blind, placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate + prednisone (abiraterone) to prednisone alone in chemotherapy-naïve, asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients from China, Malaysia, Thailand and Russia.

Methods: Adult chemotherapy-naïve patients with confirmed prostate adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade 0-1, ongoing androgen deprivation (serum testosterone <50 ng/dL) with prostate specific antigen (PSA) or radiographic progression were randomized to receive abiraterone acetate (1000 mg, QD) + prednisone (5 mg, BID) or placebo + prednisone (5 mg, BID), until disease progression, unacceptable toxicity or consent withdrawal. Primary endpoint was improvements in time to PSA progression (TTPP).

Results: Totally, 313 patients were randomized (abiraterone: n = 157; prednisone: n = 156); and baseline characteristics were balanced. At clinical cut-off (median follow-up time: 3.9 months), 80% patients received treatment (abiraterone: n = 138, prednisone: n = 112). Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone, attaining 58% reduction in PSA progression risk (HR = 0.418; p 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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