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

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.

NCT02036060 https://clinicaltrials.gov/ct2/show/NCT02036060.

European journal of cancer (Oxford, England : 1990). 2022 Sep 10 [Epub ahead of print]

Miguel A Climent, Albert Font, Ignacio Durán, Javier Puente, María José Méndez-Vidal, María Isabel Sáez, Carmen Santander Lobera, Jóse Ángel Arranz Arija, Aranzazu González-Del-Alba, Alfredo Sánchez-Hernandez, Maria Jose Juan Fita, Emilio Esteban, Teresa Alonso-Gordoa, Begoña Mellado Gonzalez, Pablo Maroto, Martín Lázaro-Quintela, Javier Cassinello-Espinosa, Begoña Pérez-Valderrama, Carmen Garcias, Daniel Castellano

Medical Oncology, Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain. Electronic address: ., Medical Oncology, Instituto Catalá d'Oncologia (ICO), Badalona, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. Electronic address: ., Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain. Electronic address: ., Medical Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC) Hospital Universitario Reina Sofia (HURS), Córdoba, Spain. Electronic address: ., UGCI Oncología Médica, Hospitales Universitarios Virgen de la Victoria y Regional de Málaga, Málaga, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain. Electronic address: ., Medical Oncology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Puerta de Hierro, Madrid, Spain. Electronic address: ., Medical Oncology Department, Consorcio Hospitalario Provincial de Castellón, Castellón, Spain. Electronic address: ., Medical Oncology, Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Central de Asturias, Oviedo, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain. Electronic address: ., Medical Oncology, Hospital Clínic de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain. Electronic address: ., Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. Electronic address: ., Medical Oncology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. Electronic address: ., Medical Oncology, Hospital Universitario de Guadalajara, Guadalajara, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla, Spain. Electronic address: ., Medical Oncology, Hospital Universitario Son Espases, Palma de Mallorca, Spain. Electronic address: ., Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: .

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