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

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.

Informations de copyright

Copyright © 2021. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: E.E. has received research grant support; served as a member of the advisory board and received honoraria and travel expense from Sanofi, Janssen, Astellas, Tolmar, Merck, AstraZeneca, Bayer, Pfizer and Oric. C.J.L. has served as a consultant or as a member of the advisory board of Janssen; has received research funding from Bristol-Myers-Squibb, Janssen and Pfizer; has received honoraria from Janssen and has participated in scientific advisory committees for Pfizer. S.K.S. has served as a consultant and/or as a member of the advisory board of Valeant, Dendreon, Apricity Health, Janssen, Polaris, Amgen, Bayer and Exelixis; has received research funding from Janssen, Bristol-Myers-Squibb and AstraZeneca; has received honoraria from Compugen, Apricity Health, Janssen, Dendreon, Polaris, Parker Institute of Cancer Immunotherapy and Society for Immunotherapy of Cancer and has ownership interest with Apricity Health. N.S., M.B., I.A., J.D., A.Z., X.W., S-M.T., B.F.C., A.A., P.C., J.W., J.A., J.P., L.P. and J.A.W. have no competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.