Prostate Cancer

New Indication: Maintenance Darolutamide for CRPC

2023-03-15

  • Study

    Randomized , phase 2 trial
    Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane
    Darolutamide (n=92)


  • Efficacy

    12 weeks rPFS: 64.7 vs 52.2%, p=0.127
    Median rPFS: 5.5 vs 4.5 mos , HR:0.54, p=0.017
    Median EFS: 5.4 vs. 2.9 mos, HR:0.46, p=0.001
    PSA 50% RR:22 vs. 4%, p=0.010
    Median OS: 24 vs. 21.3 mos,HR:0.62, p=0.181

  • Safety

    Any grade AEs: fatigue (9 vs.13%), nausea (7 vs. 4%), pruritus (4 vs. 0%)
    Grade≥3 AEs: peripheral edema (2 vs. 0%)



    • J Clin Oncol 2023; 10 FEB

    Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)

    http://doi.org/10.1200/JCO.22.01726

    Reviewed by Elvin Chalabiyev, MD on Mar 15, 2023