Abiraterone acetate plus prednisone in non-metastatic biochemically recurrent castration-naïve prostate cancer

Nicholas Spetsieris, Myrto Boukovala, Ioannis Alafis, John Davis, Amado Zurita, Xuemei Wang, Shi Ming Tu, Brian F. Chapin, Ana Aparicio, Paul Corn, Jennifer Wang, Sumit K. Subudhi, John Araujo, John Papadopoulos, Lisa Pruitt, Justin A. Weldon, Christopher J. Logothetis, Eleni Efstathiou

Research output: Contribution to journalArticlepeer-review


Background: Intermittent androgen deprivation therapy (ADT) in biochemically recurrent castration-naïve prostate cancer is non-inferior to continuous therapy. We hypothesised that finite-duration abiraterone acetate plus prednisone (Abi +P) added to ADT will further reduce the duration of treatment exposure by prolonging time to prostate-specific antigen (PSA) recurrence without impacting eugonad state recovery. Methods: This phase II, randomised, open-label trial enrolled patients with rising PSA ≥ 0.2 ng/ml after radical prostatectomy and/or a PSA ≥ 1 following radiotherapy. Patients were randomised 1:1 to receive Abi (1 g PO daily) + P (5 mg PO daily) + ADT or ADT alone for 8 months. The primary end-point was PSA-free survival difference at 1 year following completion of therapy. Results: Between February 2013 and July 2016, 200 patients were enrolled. Of 100 patients randomised to each arm, 99 in the Abi +P arm and 98 in the ADT arm were evaluable. Median follow-up was 64.4 months. Median PSA-free survival was 27.0 months for the Abi +P-treated group versus 19.9 months for the ADT-treated group (hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.47–0.87). The PSA-free survival at 1 year post-treatment completion was 98% for the Abi +P group and 88% for the ADT group. Median time to eugonad state was 13.1 months for the abiraterone-treated group and 12.8 months for the ADT-treated group. Median eugonad PSA-free survival was 12.5 months for the abiraterone-treated group versus 9.0 for the ADT-treated group (HR 0.72, 95% CI 0.53–0.98). There were no significant between-group differences in androgen deprivation-related adverse events. Conclusions: In men with biochemically recurrent prostate cancer following definitive treatment of the primary, finite duration treatment with ADT and Abi +P results in a significantly longer PSA relapse-free interval than treatment with ADT alone.

Original languageEnglish (US)
Pages (from-to)259-267
Number of pages9
JournalEuropean Journal of Cancer
StatePublished - Nov 2021


  • Abiraterone acetate
  • Androgen deprivation therapy
  • Biochemically recurrent prostate cancer
  • Hormone-naïve prostate cancer
  • PSA-free survival
  • Time to PSA relapse

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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