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New Protocol: Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer 

New Protocol: Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer 
Study:
  • Open-label, randomised, phase 3 study (PEACE-1)
  • De novo metastatic prostate adenocarcinoma
  • Standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m2 once every 3 weeks, N:296), standard of care plus radiotherapy (N:293), standard of care plus abiraterone (N:292), or standard of care plus radiotherapy plus abiraterone (N:291)
Efficacy:
  • Patients assigned to receive abiraterone (n=583) had longer radiographic PFS [HR:0·54, 0·41–0·71; p<0·0001] and OS [0·82, 0·69–0·98; p=0·030] than patients who did not receive abiraterone (n=589)
  • mOS: 5·72 years vs 4·72 years (abiraterone plus SOC vs SOC)
Safety:
  • Grade >= 3 AEs : 63% vs 52% (abiraterone, ADT plus docetaxel vs ADT plus docetaxel), hypertencion (22% vs 13%)

Lancet. 2022 Apr 30;399(10336):1695-1707.

Fizazi, Karim et al. “Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design.

https://doi.org/10.1016/s0140-6736(22)00367-1

Reviewed by Hasan Çağrı Yıldırım, MD on May 30, 2022

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