Key Clinical Summary: 

• Design/Population: The phase 3 PEACE-2 trial enrolled 761 patients with very high-risk localized prostate cancer receiving long-term ADT and prostate-directed radiotherapy. Patients were randomized to receive cabazitaxel, pelvic radiotherapy, both, or standard therapy alone.
• Key Outcomes: Cabazitaxel did not improve progression-free survival or overall survival compared with standard therapy. Higher-grade toxicities were more common in patients receiving cabazitaxel.
• Clinical Relevance: These findings do not support routine addition of cabazitaxel to standard therapy in very high-risk localized prostate cancer. The low rate of prostate cancer-related mortality raises questions about current risk stratification in the context of modern imaging.

Results from the phase 3 PEACE-2 trial demonstrated that adding cabazitaxel to long-term androgen deprivation therapy (ADT) and radiotherapy does not improve progression-free survival (PFS) among patients with very high-risk localized prostate cancer.

These results were presented by Karim Fizazi, MD, PhD, University of Paris Saclay, Lille, France, at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, California.

In this study, 761 patients who received prostate-only fractionated radiotherapy (74 to 78 Gy in 37 to 39 fractions) plus 3 years of ADT were randomized in a 2×2 factorial design to receive standard therapy alone or in combination with prophylactic pelvic radiotherapy (46 to 50 Gy in 23 to 25 fractions), 4 cycles of cabazitaxel (20 to 25 mg/m² every 3 weeks) prior to radiotherapy (n = 381), or both cabazitaxel and pelvic radiotherapy (n = 380). The primary end point was PFS. Key secondary end points included overall survival (OS) and safety.

At a median follow-up of 85 months, no interaction was observed between cabazitaxel and pelvic radiotherapy. The 6-year PFS rate was 67.2% in patients receiving cabazitaxel and 71.4% in those not receiving cabazitaxel. OS exceeded 85% across all treatment arms, with no significant differences observed. Grade >2 toxicities occurred in 65% of patients receiving cabazitaxel and 47% of those not receiving cabazitaxel.

“With very few prostate cancer-related deaths observed during the first decade, data from PEACE-2 challenge our current definition of very-high risk localized prostate cancer, especially when defined using modern imaging,” concluded Dr Fizazi. 

Source: 

Fiazi K, Carles J, Foulon S, et al. Androgen deprivation therapy and radiotherapy with or without cabazitaxel in very-high risk localized prostate cancer: First results of the PEACE-2 randomized phase III trial. Presented at ASCO GU. February 26-28, 2026. San Francisco, California. LBA307.