The Absolute Effect / Oncology Evidence / Evidence Index
PSMAfore
In taxane-naive PSMA-positive mCRPC progressing after one ARPI, does 177Lu-PSMA-617 improve radiographic PFS over switching to another ARPI?
Registry: NCT04689828 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III randomized open-label; n=468; crossover permitted.Primary-source evidence summaryStudy design, population and eligibility
Phase III randomized open-label; n=468; crossover permitted.
PSMA-positive mCRPC after one ARPI, taxane-naive and appropriate to delay taxane.
Treatment and comparator
Intervention: 177Lu-PSMA-617 q6 weeks up to six cycles.
Comparator: Switch to alternative ARPI.
Endpoints
rPFS by BICR primary.
Key efficacy and clinical outcomes
Primary median rPFS 9.30 vs 5.55 mo (HR .41); updated 11.60 vs 5.59 mo (HR .49); 57% control crossed over.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. Taxane-naive PSMA-positive mCRPC after one ARPI
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Grade 3–5 AEs 36% vs 48%; xerostomia, fatigue, nausea, cytopenias.
Absolute effect and NNT/NNH
Crossover complicates OS; unlike VISION, taxane-naive and comparator is ARPI switch.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Crossover complicates OS; unlike VISION, taxane-naive and comparator is ARPI switch.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.