Abstract 646TiP
Background
Although prostate cancer-related death is almost systematically due to metastatic dissemination, nowadays most prostate cancer patients have localized disease at diagnosis. Compared to radiotherapy (RT) alone, combining androgen deprivation therapy (ADT) with RT improves survival of patients with high-risk localized prostate cancer. Adding ADT plus docetaxel before prostate RT improves failure-free survival. Cabazitaxel, a second-generation taxane, is active against several docetaxel-resistant cell lines and is better tolerated than docetaxel from a patient standpoint. Furthermore, the added value of prophylactic pelvic RT in the localized setting needs to be clarified. Therefore, it was deemed of interest to evaluate the benefit of neoadjuvant ADT plus cabazitaxel and pelvic RT in the treatment of very high-risk non-metastatic prostate cancer patients.
Trial design
PEACE 2 is a 2x2 factorial design randomized trial started in December 2013 that aims to recruit 1048 patients with non-metastatic very high-risk prostate cancer (at least 2 criteria among: Gleason 8-10, T3/T4 disease, and PSA ≥20). Eligible patients are randomized in a 1:1:1:1 ratio to: Arm A: Prostate only RT + 3-years ADT Arm B: Prostate + Pelvic RT + 3-years ADT Arm C: Prostate only RT + 3-years ADT + cabazitaxel Arm D: Prostate + Pelvic RT + 3-years ADT + cabazitaxel The primary endpoint is clinical progression-free survival. 262 patients are needed in each arms and 247 events in total are needed to detect an absolute difference of 7.5% in cPFS at 6 years corresponding to a constant HR of 0.70 (5% 2-sided test, power=80%) between ADT and ADT + cabazitaxel arms, and prostate only RT and pelvic RT arms. An interim analysis is planned at 50% of the events. The trial was open to accrual in 2013 and so far 739 patients have been included.
Clinical trial identification
NCT01952223 (PEACE 2 trial).
Editorial acknowledgement
Legal entity responsible for the study
Unicancer, 101 rue de Tolbiac, 75013 Paris, France.
Funding
Sanofi.
Disclosure
P. Blanchard: Financial Interests, Personal, Other, Full or part-time employment, Editor in chief, Clinical and translational radiation oncology: ESTRO. J. Carles: Financial Interests, Personal, Advisory Board: Astellas Pharma; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb; Financial Interests, Personal, Advisory Board: Johnson & Johnson; Financial Interests, Personal, Advisory Board: MSD Oncology; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Non-Financial Interests, Institutional, Principal Investigator: Janssen-Cilag; Non-Financial Interests, Institutional, Principal Investigator: Laboratoires Leurquin Mediolanum SAS; Non-Financial Interests, Institutional, Principal Investigator: Lilly; Non-Financial Interests, Institutional, Principal Investigator: Medimmune; Non-Financial Interests, Institutional, Principal Investigator: Novartis; Non-Financial Interests, Institutional, Principal Investigator: Sanofi-Aventis. M. Gizzi: Financial Interests, Personal, Invited Speaker: Astellas Pharma; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi. P. Sargos: Financial Interests, Personal, Invited Speaker: Astellas Pharma; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Sanofi; Non-Financial Interests, Institutional, Principal Investigator: Bayer; Non-Financial Interests, Institutional, Principal Investigator: Ipsen. L.A. Marques Da Costa: Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Servier. I. Latorzeff: Financial Interests, Personal, Invited Speaker, Board or communication: Astellas Pharma; Financial Interests, Personal, Invited Speaker, Board or communication: Ipsen; Financial Interests, Personal, Advisory Board: Janssen. E. Gallardo: Financial Interests, Personal, Invited Speaker: Astellas Pharma; Financial Interests, Personal, Advisory Board: Astelles Pharma; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Invited Speaker: EUSA Pharma; Financial Interests, Personal, Advisory Board: EUSA Pharma; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Invited Speaker: Menarini; Financial Interests, Personal, Invited Speaker: Merck; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: Merck; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Rovi; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Techdow; Financial Interests, Institutional, Principal Investigator: Astellas Pharma; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: Aveo; Financial Interests, Institutional, Principal Investigator: Bayer; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Clovis; Financial Interests, Institutional, Principal Investigator: Daiichi Sankyo; Financial Interests, Institutional, Principal Investigator: Exelixis; Financial Interests, Institutional, Principal Investigator: Immunicum; Financial Interests, Institutional, Principal Investigator: Incyte; Financial Interests, Institutional, Principal Investigator: Ipsen; Financial Interests, Institutional, Principal Investigator: Janssen; Financial Interests, Institutional, Principal Investigator: Lilly; Financial Interests, Institutional, Principal Investigator: Mediolanum; Financial Interests, Institutional, Principal Investigator: Medivation; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: QED Therapeutics; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: Seattle Genetics; Non-Financial Interests, Personal, Leadership Role: SOGUG. K. Fizazi: Financial Interests, Institutional, Advisory Board: AAA; Financial Interests, Institutional, Invited Speaker: Astellas; Financial Interests, Institutional, Advisory Board: Astellas; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Bayer; Financial Interests, Institutional, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Curevac; Financial Interests, Institutional, Invited Speaker: Janssen; Financial Interests, Institutional, Advisory Board: Janssen; Financial Interests, Institutional, Invited Speaker: MSD; Financial Interests, Institutional, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Orion; Financial Interests, Institutional, Invited Speaker: Sanofi; Financial Interests, Institutional, Research Grant, Trial chair: AstraZeneca; Financial Interests, Institutional, Research Grant, Trial chair: Bayer; Financial Interests, Institutional, Research Grant, Trial chair: BMS; Financial Interests, Institutional, Research Grant, Trial chair: Janssen; Financial Interests, Institutional, Research Grant, Trial chair: MSD; Financial Interests, Institutional, Research Grant, Trial chair: Orion; Financial Interests, Institutional, Research Grant, Trial chair: Pfizer. All other authors have declared no conflicts of interest.