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Genitourinary tumours, prostate

1275 - Abiraterone acetate (AA) + Prednisolone (P) for metastatic Castration-Resistant Prostate Cancer (mCRPC) with early progression or non-response to Androgen Deprivation Therapy (ADT)


10 Sep 2017


Genitourinary tumours, prostate


Cytotoxic Therapy;  Prostate Cancer


Gaku Arai


Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370


G. Arai1, M. Ogi2, K. Kobayashi3, N. Okuno4, T. Takahara2, K. Fukushima2, K. Yoshizawa2

Author affiliations

  • 1 Department Of Urology, Dokkyo Medical University Koshigaya Hospital, 343-8555 - Saitama/JP
  • 2 Medical Affairs Division, Janssen Pharmaceutical K.K., 101-0065 - Tokyo/JP
  • 3 Urology Department, Yokosuka Kyosai Hospital, 238-8558 - Kanagawa/JP
  • 4 Department Of Urology, Sagamihara Hospital, 252-0392 - Kanagawa/JP


Abstract 1275


mCRPC with early progression (≤1year) or non-response to initial ADT carries a poor prognosis, and there is no consensus regarding second-line therapy for these patients (pts) [ADT poor responders]. Although AA+P is effective for chemo-naïve mCRPC, limited data is available for ADT poor responders; thus, we conducted this study to evaluate the efficacy and safety of AA+P as secondary treatment for this population.


This was a multicenter, open-label, single arm, 2-stage trial according to Simon’s minimax design [hypothesis: p0=0.150, p1=0.350, α = 0.025, β = 0.100], and 48 pts were required to efficacy analysis. Key eligibility: Chemo-naïve mCRPC (testosterone level


Fifty pts were enrolled and 49 were evaluable for efficacy analysis. At baseline, the median age was 73 (range 55–86), the median PSA level was 28.34ng/mL (2.28-294.25), and the median duration of initial ADT was 6.4 months (1.4 –18.8). Among the patients, 90.0% had a total Gleason score ≥8, and all had a treatment history of bicalutamide. Most patients showed high treatment compliance (>95% with AA [n = 47/50, 94.0%] and P [n = 46/50, 92.0%]). PSA response rate was 55.1% (n = 27/49; 95%CI 41.3-68.1), and the PSA decline began after 4 or 8 weeks from baseline. The treatment was well tolerated with


This is the first study to investigate the efficacy of AA+P for ADT poor responders. The study demonstrated similar efficacy to the Phase 3 study COU-AA-302, which further supports the efficacy of AA+P for ADT poor responders. AA + P appears to be a promising treatment for initial ADT poor responders with an acceptable safety profile. This study is ongoing as follow up on time to PSA progression.

Clinical trial identification

NCT02405858 (March 27, 2015).

Legal entity responsible for the study

Janssen Pharmaceutical K.K.


Janssen Pharmaceutical K.K.


G. Arai: Clinical trials sponsored by AstraZeneca, Green Peptide, Janssen, MSD and Shionogi during the conduct of the study. M. Ogi, T. Takahara, K. Fukushima, K. Yoshizawa: Eemployee of Janssen Pharmaceutical K.K. K. Kobayashi: Clinical trials sponsored by Astellas, Bayer, Janssen and MSD during the conduct of the study. N. Okuno: Clinical trials sponsored by Astrazeneca, Janssen and Pfizer during the conduct of the study.

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