Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Gerhardt AttardPLATO collaborators

Abstract

Purpose Enzalutamide resistance could result from raised androgens and be overcome by combination with abiraterone acetate. PLATO ( ClinicalTrials.gov identifier: NCT01995513) interrogated this hypothesis using a randomized, double-blind, placebo-controlled design. Patients and Methods In period one, men with chemotherapy-naïve metastatic castration-resistant prostate cancer received open-label enzalutamide 160 mg daily. Men with no prostate-specific antigen (PSA) increase at weeks 13 and 21 were treated until PSA progression (≥ 25% increase and ≥ 2 ng/mL above nadir), then randomly assigned at a one-to-one ratio in period two to abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily with either enzalutamide or placebo (combination or control group, respectively) until disease progression as defined by the primary end point: progression-free survival (radiographic or unequivocal clinical progression or death during study). Secondary end points included time to PSA progression and PSA response in period two. Results Of 509 patients enrolled in period one, 251 were randomly assigned in period two. Median progression-free survival was 5.7 months in the combination group and 5.6 months in the control group (hazard ratio...Continue Reading

References

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Citations

Mar 21, 2019·Current Opinion in Oncology·David J EinsteinSteven P Balk
Oct 1, 2019·The New England Journal of Medicine·Ronald de WitUNKNOWN CARD Investigators
Dec 18, 2019·Nature Reviews. Urology·Sabine Schmid, Aurelius Omlin
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Jun 20, 2020·European Urology·Deborah MukherjiCarmel Pezaro
Jul 15, 2021·Nature Cancer·Joaquin MateoHimisha Beltran

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Clinical Trials Mentioned

NCT01650194
NCT01949337
NCT02268175

Software Mentioned

PLATO

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