The Absolute Effect / Oncology Evidence / Evidence Index
VISION
In PSMA-positive mCRPC previously treated with an ARPI and taxane chemotherapy, does 177Lu-PSMA-617 plus standard care improve radiographic PFS and OS?
Registry: NCT03511664 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III randomized; n=831.Primary-source evidence summaryStudy design, population and eligibility
Phase III randomized; n=831.
PSMA-positive mCRPC after ≥1 ARPI and 1–2 taxane regimens.
Treatment and comparator
Intervention: 177Lu-PSMA-617 7.4 GBq q6 weeks up to 6 cycles + standard care.
Comparator: Protocol-permitted standard care.
Endpoints
Imaging-based PFS and OS co-primary.
Key efficacy and clinical outcomes
Median imaging PFS 8.7 vs 3.4 mo (HR .40); OS 15.3 vs 11.3 mo (HR .62).
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. PSMA-positive mCRPC after ARPI and taxane
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Grade ≥3 AEs 52.7% vs 38%; fatigue, dry mouth, nausea, cytopenias and renal/marrow exposure.
Absolute effect and NNT/NNH
Post-ARPI/post-taxane population; selection by PSMA PET and control-arm restrictions matter.
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
Post-ARPI/post-taxane population; selection by PSMA PET and control-arm restrictions matter.
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.