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Axel Merseburger, MD, PhD, discusses results from the phase 3b PRESIDE trial in metastatic castration-resistant prostate cancer.
Axel Merseburger, MD, PhD, chairman, Clinic of Urology, University Hospital Schleswig-Holstein in Lübeck, Germany, discusses results from the phase 3b PRESIDE trial (NCT02288247) in metastatic castration-resistant prostate cancer (mCRPC).
The randomized study investigated the efficacy of continuing enzalutamide (Xtandi) plus androgen deprivation therapy (ADT) with docetaxel and prednisolone in chemotherapy-naïve patients with mCRPC who had progressed on enzalutamide plus ADT. All enrolled patients were administered 160 mg of enzalutamide plus ADT in period 1 of the trial. Patients who experienced a change in prostate-specific antigen response of at least 50% from baseline to week 13 and subsequent disease progression were then randomized to receive enzalutamide or placebo, plus 75 mg/m2 of docetaxel, 10 mg of prednisolone, and ADT.
The continuation of enzalutamide produced a statistically significant advantage in progression-free survival (PFS) compared with placebo, meeting the trial’s primary end point, Merseburger says. The hazard ratio for PFS was 0.72 in favor of the enzalutamide combination with a corresponding P value of .027, Merseburger concludes.