Randomized phase III trial with a factorial design assessing the efficacy and safety of darolutamide and stereotactic dose-escalated radiotherapy in patients with high-risk localized prostate cancer: the PEACE 7 (GETUG-AFU 45) study protocol

The PEACE 7 study protocol describes an international, multicenter, randomized, open-label phase III trial designed to evaluate whether adding darolutamide, a prostate-targeted stereotactic body radiotherapy boost, or both to standard treatment improves outcomes in adult men with high-risk localized prostate cancer. The research is a trial protocol rather than a report of efficacy or safety results, so the effects of either experimental addition remain to be determined.

The planned population consists of adults with high-risk prostate cancer and no detectable metastasis on PSMA PET/CT imaging. To meet the study’s high-risk definition, patients must have at least two of three specified features: a Gleason score of at least 8, T3 or T4 disease, or a prostate-specific antigen concentration of at least 20 ng/mL. Investigators plan to enroll 700 patients over three years. Randomization will use a 2 × 2 factorial design, with participants assigned in equal proportions to four groups. All groups will receive androgen deprivation therapy and prostate and pelvic nodal radiotherapy, described in the abstract as standard treatment.

Arm A will receive standard treatment alone. Arm B will receive standard treatment plus darolutamide, Arm C will receive standard treatment plus a prostate stereotactic body radiotherapy boost, and Arm D will receive standard treatment plus both the radiotherapy boost and darolutamide. Randomization will be stratified according to the number of high-risk factors, either two or three; the presence or absence of a dominant intraprostatic lesion, classified as PI-RADS 5 or not; and the treatment center. The protocol is registered as 2023-509787-15-00 in the EU Clinical Trials Register and NCT06625970 on ClinicalTrials.gov.

The primary endpoint is metastasis-free survival. The protocol specifies a targeted hazard ratio of 0.65, with 170 events required to provide 80% power at a two-sided significance level of 5%. Planned secondary endpoints are clinical progression-free survival, biochemical progression-free survival, time to local relapse, overall survival, prostate cancer-specific survival, acute and long-term toxicity, and quality of life. These are prespecified analytical targets and do not represent observed benefits. The abstract provides no results on metastasis-free survival, adverse effects, quality of life, or any other outcome, and the study’s open-label design and international multicenter scope do not themselves establish treatment effectiveness. PEACE 7 is intended to assess the contributions of darolutamide and dose escalation with a stereotactic radiotherapy boost within the stated population and treatment regimen; conclusions about safety or efficacy must await the trial’s findings.

Subject of Research: A factorial phase III protocol evaluating darolutamide and stereotactic radiotherapy in high-risk localized prostate cancer

Article Title: Randomized phase III trial with a factorial design assessing the efficacy and safety of darolutamide and stereotactic dose-escalated radiotherapy in patients with high-risk localized prostate cancer: the PEACE 7 (GETUG-AFU 45) study protocol

Article References: Crehange, G., Blanchard, P., Foulon, S., La, C., Demogeot, N., Martin, J., Léger, C., Guirao, J., & Fizazi, K. (2026). Randomized phase III trial with a factorial design assessing the efficacy and safety of darolutamide and stereotactic dose-escalated radiotherapy in patients with high-risk localized prostate cancer: the PEACE 7 (GETUG-AFU 45) study protocol. BMC Cancer. https://doi.org/10.1186/s12885-026-16802-9

Image Credits: AI Generated

DOI: 10.1186/s12885-026-16802-9

Keywords: PEACE 7, prostate cancer, phase III trial, study protocol, darolutamide, stereotactic radiotherapy, androgen deprivation therapy, metastasis-free survival, randomized trial, prostate radiotherapy, Randomized, phase