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Prostate Cancer · Medical · Perioperative Therapy

PROTEUS

In high-risk localized or locally advanced prostate cancer undergoing prostatectomy, does perioperative apalutamide plus ADT improve metastasis-free survival?

Tumour site
Prostate Cancer
Discipline
Medical
Clinical setting
Perioperative Therapy
Evidence type
Comparative clinical evidence

Absolute Effect

PROTEUS randomized 2,109 men to perioperative ADT plus apalutamide or ADT plus placebo around radical prostatectomy. Five-year metastasis-free survival was 78.2% versus 73.5%, an absolute improvement of 4.7 percentage points (HR 0.80, 95% CI 0.67–0.96).

NNT / NNH: Calculated only when a defensible fixed-time absolute event difference is available. Hazard ratios alone are not converted into NNT.

Clinical interpretation

The reported metastasis-free-survival benefit with perioperative apalutamide plus ADT is new phase III evidence for high-risk localized/locally advanced prostate cancer; adoption depends on approval and guideline implementation.

Limitations

The result applies to trial-defined high-risk patients undergoing prostatectomy and should not be extrapolated to low-risk disease or assumed to replace established salvage pathways.

Primary / authoritative source

Current-practice context · reviewed 14 October 2026

PROTEUS reports a metastasis-free-survival benefit from perioperative apalutamide plus ADT around prostatectomy in high-risk localized/locally advanced disease. This is new phase III evidence; implementation should follow current regulatory approval, guideline adoption, eligibility criteria and toxicity assessment. Do not extrapolate to lower-risk disease or assume it replaces established postoperative/salvage strategies in every patient.

PROTEUS primary/registry source ↗ · Current guideline guidance ↗