No added benefit from cabazitaxel in VHR PC

By Sudha Thakor

“Adding cabazitaxel to long‑term androgen deprivation therapy [ADT] and radiotherapy did not improve clinical outcomes in men with very high–risk localized prostate cancer,” Karim Fizazi (Centre Oscar Lambret, University of Paris Saclay, Lille, France) concluded, when presenting first results from the phase 3 PEACE‑2 trial at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2026.

The PEACE‑2 trial evaluated whether intensifying standard-of-care treatment with cabazitaxel could improve clinical progression-free survival (cPFS) in this population, for whom long-term ADT plus radiotherapy remains the treatment standard. Although docetaxel has shown benefit in selected high-risk settings, the role of other taxanes in localized disease has remained unclear.

The randomized 2×2 phase 3 study enrolled 761 men with very high–risk localized prostate cancer, defined by at least two risk factors, including T3–4 disease, Gleason score 8–10, or prostate-specific antigen (PSA) ≥20 ng/mL, with no nodal or metastatic disease on conventional imaging. Patients received ADT with either pelvic or prostate-only radiotherapy and were randomized to receive cabazitaxel or no additional chemotherapy. Cabazitaxel was administered every 3 weeks for four cycles.

After a median follow-up of 7.3 years, no significant difference in the primary endpoint of cPFS was observed between treatment arms. Seven-year cPFS rates were 67.2% in patients without cabazitaxel and 62.8% with cabazitaxel, with no interaction between cabazitaxel use and pelvic radiotherapy. Secondary endpoints, including biochemical PFS and metastasis-free survival, were also similar between groups.

Long-term outcomes for this population were favorable overall, with prostate cancer–specific survival of approximately 90% at 9 years, highlighting durable disease control with current standard approaches in many men with very high–risk localized disease.

Treatment intensification, however, increased toxicity. Grade 3–4 adverse events were more frequent with cabazitaxel, driven largely by hematologic toxicities such as neutropenia. Adverse events were otherwise consistent with the known safety profile of cabazitaxel.

Investigators concluded that cabazitaxel does not improve outcomes when added to ADT and radiotherapy for very high-risk localized prostate cancer. “Given the relatively low prostate cancer mortality observed over the first decade of follow-up, current definitions of ‘very high-risk’ disease may warrant reconsideration, particularly as modern imaging techniques such as PSMA PET increasingly refine staging,” Fizazi concluded.

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