%0 Journal Article
%A Climent, Miguel A
%A Font, Albert
%A Duran, Ignacio
%A Puente, Javier
%A Mendez-Vidal, Maria Jose 
%A Saez, Maria Isabel
%A Santander-Lobera, Carmen
%A Angel-Arranz-Arija, Jose
%A Gonzalez-Del-Alba, Aranzazu
%A Sanchez-Hernandez, Alfredo
%A Juan-Fita, Maria Jose
%A Esteban, Emilio
%A Alonso-Gordoa, Teresa
%A Mellado-Gonzalez, Begoña
%A Maroto, Pablo
%A Lazaro-Quintela, Martin
%A Cassinello-Espinosa, Javier
%A Perez-Valderrama, Begoña
%A Garcias, Carmen
%A Castellano, Daniel
%T 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.
%D 2022
%U http://hdl.handle.net/10668/22179
%X We 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. 
%K Abiraterone acetate
%K Combination
%K Docetaxel
%K Metastatic castration-resistant prostate cancer
%K Phase II
%~