1. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design.
- Author
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UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, Fizazi, Karim, Foulon, Stéphanie, Carles, Joan, Roubaud, Guilhem, McDermott, Ray, Fléchon, Aude, Tombal, Bertrand, Supiot, Stéphane, Berthold, Dominik, Ronchin, Philippe, Kacso, Gabriel, Gravis, Gwenaëlle, Calabro, Fabio, Berdah, Jean-François, Hasbini, Ali, Silva, Marlon, Thiery-Vuillemin, Antoine, Latorzeff, Igor, Mourey, Loïc, Laguerre, Brigitte, Abadie-Lacourtoisie, Sophie, Martin, Etienne, El Kouri, Claude, Escande, Anne, Rosello, Alvar, Magne, Nicolas, Schlurmann, Friederike, Priou, Frank, Chand-Fouche, Marie-Eve, Freixa, Salvador Villà, Jamaluddin, Muhammad, Rieger, Isabelle, Bossi, Alberto, PEACE-1 investigators, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, Fizazi, Karim, Foulon, Stéphanie, Carles, Joan, Roubaud, Guilhem, McDermott, Ray, Fléchon, Aude, Tombal, Bertrand, Supiot, Stéphane, Berthold, Dominik, Ronchin, Philippe, Kacso, Gabriel, Gravis, Gwenaëlle, Calabro, Fabio, Berdah, Jean-François, Hasbini, Ali, Silva, Marlon, Thiery-Vuillemin, Antoine, Latorzeff, Igor, Mourey, Loïc, Laguerre, Brigitte, Abadie-Lacourtoisie, Sophie, Martin, Etienne, El Kouri, Claude, Escande, Anne, Rosello, Alvar, Magne, Nicolas, Schlurmann, Friederike, Priou, Frank, Chand-Fouche, Marie-Eve, Freixa, Salvador Villà, Jamaluddin, Muhammad, Rieger, Isabelle, Bossi, Alberto, and PEACE-1 investigators
- Abstract
Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care. We conducted an open-label, randomised, phase 3 study with a 2 × 2 factorial design (PEACE-1) at 77 hospitals across Belgium, France, Ireland, Italy, Romania, Spain, and Switzerland. Eligible patients were male, aged 18 years or older, with histologically confirmed or cytologically confirmed de novo metastatic prostate adenocarcinoma, and an Eastern Cooperative Oncology Group performance status of 0-1 (or 2 due to bone pain). Participants were randomly assigned (1:1:1:1) to standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m once every 3 weeks), standard of care plus radiotherapy, standard of care plus abiraterone (oral 1000 mg abiraterone once daily plus oral 5 mg prednisone twice daily), or standard of care plus radiotherapy plus abiraterone. Neither the investigators nor the patients were masked to treatment allocation. The coprimary endpoints were radiographic progression-free survival and overall survival. Abiraterone efficacy was first assessed in the overall population and then in the population who received androgen deprivation therapy with docetaxel as standard of care (population of interest). This study is ongoing and is registered with ClinicalTrials.gov, NCT01957436. Between Nov 27, 2013, and Dec 20, 2018, 1173 patients were enrolled (one patient subsequently withdrew consent for analysis of his data) and assigned to receive standard of care (n=296), standard of care plus radiotherapy (n=293), standard of care plus abiraterone (n=292), or standard of care plus radiotherapy plus abiraterone (n=291). Median follow-up was 3·5 years (IQR 2·8-4·6) for radiographic progression-free survival an
- Published
- 2022