Climent, Miguel AFont, AlbertDuran, IgnacioPuente, JavierMendez-Vidal, Maria JoseSaez, Maria IsabelSantander-Lobera, CarmenAngel-Arranz-Arija, JoseGonzalez-Del-Alba, AranzazuSanchez-Hernandez, AlfredoJuan-Fita, Maria JoseEsteban, EmilioAlonso-Gordoa, TeresaMellado-Gonzalez, BegoñaMaroto, PabloLazaro-Quintela, MartinCassinello-Espinosa, JavierPerez-Valderrama, BegoñaGarcias, CarmenCastellano, Daniel2023-05-032023-05-032022-08-04Climent MA, Font A, Durán I, Puente J, José Méndez-Vidal M, Sáez MI, et al. A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial. Eur J Cancer. 2022 Nov;175:110-119http://hdl.handle.net/10668/22179We aimed to compare the efficacy and safety of maintaining or withdrawing abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer who had experienced cancer progression to this treatment and were beginning a docetaxel-based therapy. Phase II, randomised, open-label study conducted in patients with metastatic castration-resistant prostate cancer who were asymptomatic or mildly symptomatic. After open-label treatment with AAP, patients who had experienced cancer progression to AAP were randomised to 75 mg/m2 of docetaxel plus AAP or to receive 75 mg/m2 of docetaxel plus 10 mg of prednisone orally daily. The primary outcome was the radiographic progression-free survival rate at 12 months as evaluated by the investigators in all randomised patients. A total of 148 patients were included in open-label treatment with AAP, and of them, 94 patients were randomised to receive either docetaxel plus AAP (intervention group; n = 47) or docetaxel plus prednisone (control group; n = 47). The 12-month radiographic progression-free survival rates did not differ between the intervention group (34.9%; 95% CI 20.7-49.2) and the control group (33.9%; 95% CI 19.5-48.3). There were no significant differences in the time to radiographic progression and the overall survival between the intervention and control groups. Grade 3-5 neutropenia with the combination of docetaxel plus prednisone and AA was more frequent than with docetaxel plus prednisone (59.6% versus 27.7%). Our results indicate that the therapeutic strategy of maintaining AAP added to docetaxel in chemotherapy-naïve patients who have experienced cancer progression to AAP treatment should not be further evaluated and should be avoided in clinical practice.enAbiraterone acetateCombinationDocetaxelMetastatic castration-resistant prostate cancerPhase IIAbiraterone acetateAntineoplastic combined chemotherapy protocolsDisease progressionDocetaxelHumansMalePrednisoneProstatic neoplasms, castration-resistantTreatment outcomeresearch article36099670Restricted accessAcetato de abirateronaNeoplasias de la próstata resistentes a la castraciónPrednisonaProgresión de la enfermedadProtocolos de quimioterapia combinada antineoplásicaResultado del tratamiento10.1016/j.ejca.2022.08.0021879-0852