Abiraterone acetate added to androgen-deprivation therapy and docetaxel resulted in a significant overall survival benefit compared with standard-of-care therapy alone in patients with de novo metastatic castration-sensitive prostate cancer, according to long-term findings from the phase III PEACE-1 trial presented at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract 2215O).
“There is a major survival benefit, with almost 2 years of additional life for patients receiving the three treatments, which is of course highly significant,” said lead author Karim Fizazi, MD, PhD, Chief Executive Officer at the Centre Oscar Lambret in Lille, France. “In our opinion, this makes this triplet treatment a strong standard of care for these patients.”
Background and Study Methods
PEACE-1 is a 2x2 factorial, randomized phase III trial that explored the addition of abiraterone acetate and prednisone and/or prostate radiotherapy to standard therapy in men with metastatic castration-sensitive prostate cancer. The study included 1,173 men with de novo metastatic castration-sensitive prostate cancer who were randomly assigned (1:1:1:1) to receive the standard of care of androgen-deprivation therapy with or without docetaxel, added abiraterone acetate plus prednisone, added radiotherapy to the prostate, or both abiraterone acetate plus prednisone and radiotherapy with standard of care.
Earlier study findings demonstrated a survival benefit with the addition of abiraterone acetate (hazard ratio [HR] = 0.82; P = .030).
Key Findings
Follow-up continued for a median of 7.7 years. Median overall survival across the treatment arms after extended follow-up was 4.6 years for standard of care; 4.6 years for standard of care with radiotherapy; 5.7 years with standard of care and abiraterone acetate; and 6.4 years for standard of care, radiotherapy, and abiraterone acetate. Comparing the addition of abiraterone to standard of care, the hazard ratio was 0.75 (95% confidence interval [CI] = 0.65–0.87; P = .0001).
Among the patients who received standard of care of androgen-deprivation therapy with docetaxel, adding abiraterone acetate improved survival (hazard ratio [HR] = 0.68) and demonstrated 8-year overall survival rates of 27.1% with standard of care alone vs 40.3% with added abiraterone acetate.
The effect from added abiraterone acetate on overall survival was considered independent of metastatic extent (interaction test P = .56), as patients with high-volume disease (57%) and low-volume disease (43%) both showed improvement from triplet therapy vs doublet therapy (high-volume HR = 0.68; low-volume HR = 0.74), though the difference was not statistically significant on its own for patients with low-volume disease.
“Most clinical trials... tend to stop their follow-up early,” Dr. Fizazi added. “This long-term analysis demonstrated that the survival benefit becomes greater with time: for instance, in men with multiple metastases at diagnosis, there are almost twice as many long-term survivors with triplet therapy.”
In patients in the control arms whose disease progressed on treatment, 86% then received an androgen receptor pathway inhibitor. The study authors suggested that the findings support starting treatment early rather than waiting for disease progression.
No new long-term safety concerns were identified in the long-term analysis. In the arms of doublet or triplet therapy without radiotherapy, grade 3 or 4 hypertension was reported in 21% of patients who received triplet therapy and in 14% who received doublet therapy.
“For patients and clinicians, these data mean that modern, intensified systemic treatment—particularly triplet therapy with androgen-deprivation therapy, docetaxel, and abiraterone—can translate into a substantially improved chance of long-term disease control and survival, with toxicity that is generally manageable,” said Ursula Vogl, MD, of the Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland, who was not involved in the study.
She added that clinicians should decide about adding docetaxel to therapy based on individual patient factors as researchers are still uncertain which patients benefit the most from added chemotherapy.
DISCLOSURES: Study funding came from Johnson & Johnson, Sanofi, and Ipsen. The legal entity responsible for this study is Unicancer. Dr. Fizazi reported financial interests, institutional, advisory board: Astellas, Bayer, Janssen, MSD, AstraZeneca, Novartis/AAA, Pfizer, Daiichi Sankyo; financial interests, institutional, invited speaker: Astellas, Bayer, Janssen, MSD, AstraZeneca, Novartis, Pfizer; financial interests, personal, invited speaker: Hopes, Tactics, PeerVoice, Research to Practice, Epics, Urotoday, ED Med resources, Medscape, Health podcast, Clinical care options, Oseus, e-china health, Darman Strategik Numerik, Cancerodigest; financial interests, personal, other, comments on new data: Cancer expert now; Financial Interests, Personal, Advisory Board: Axiom, Arivan, Access infinity, Globe life sciences, Reach market research, MD to market, PSI; financial interests, institutional, research grant, trial chair: Pfizer, Bayer, AstraZeneca, Orion, MSD, BMS, Janssen; financial interests, institutional, coordinating principal investigator, trial chair: Novartis; non-financial interests, principal Investigator, chair of the 7DX phase III trial: BMS; non-financial interests, principal investigator, chair of the docetaxel-pembrolizumab phase III trial: Merck; non-financial interests, principal investigator, chair of the darolutamide BCR phase III trial: Bayer; non-financial interests, principal investigator, chair of the PSMAfore phase III trial: AAA/Novartis; non-financial interests, principal investigator, chair of the CYPIDES ODM-208 phase I-II trial: Orion; non-financial interests, principal investigator, chair of the STESIDES ODM-209 phase I-II trial: Orion; non-financial interests, principal investigator, chair of the CAPITELLO 281 phase III trial: AstraZeneca; non-financial interests, principal investigator, chair of the TALAPRO-2 and TALAPRO-3 phase III trials: Pfizer; non-financial interests, principal investigator, chair of the RADIANT phase III trial: Bayer; non-financial Interests, principal investigator, chair of the TRITON-3 phase III trial: Clovis. All other authors have declared no conflicts of interest.
