# PSMAfore

Source: https://nuclide.cc/trials/psmafore/  
Nuclide record `psmafore` (Trial). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

PSMAfore moved Pluvicto before chemotherapy in prostate cancer.

## Summary

PSMAfore, trial NCT04689828 sponsored by Novartis and published in the Lancet in 2024, moved Pluvicto, or 177Lu-PSMA-617, before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer after one androgen receptor pathway inhibitor. It randomised 468 taxane-naive men to the radioligand or a switch of androgen receptor pathway inhibitor, met its primary radiographic progression-free survival endpoint with a large effect, and overall survival was confounded by crossover of most control patients, with crossover-adjusted analyses favouring the radioligand; approval in the pre-chemotherapy setting followed in 2025. Whether earlier use improves survival, not just progression, is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT04689828
- Phase: 3
- Setting: PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 vs ARPI switch
- Sponsor: Novartis
- Enrolled: 469
- Result: rPFS HR 0.41.
- Outcomes: Radiographic progression-free survival: 177Lu-PSMA-617 12 months vs ARPI switch 5.6 months, HR 0.41; Overall survival (crossover-adjusted): 177Lu-PSMA-617 vs ARPI switch, HR 0.59
- Replication: Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter.

## Sources

- ClinicalTrials.gov NCT04689828: https://clinicaltrials.gov/study/NCT04689828

## Connected records

- isotopes: [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Metastatic castration-resistant prostate cancer](https://nuclide.cc/indications/prostate-mcrpc/), [Prostate cancer](https://nuclide.cc/indications/prostate/)
- drugs: [Lutetium-177 vipivotide tetraxetan](https://nuclide.cc/drugs/pluvicto/)
- people: [A. Oliver Sartor](https://nuclide.cc/people/oliver-sartor/), [Michael J. Morris](https://nuclide.cc/people/michael-morris/)
- terms: [Crossover in trials](https://nuclide.cc/terms/crossover/), [Estimands and intercurrent events (ICH E9(R1))](https://nuclide.cc/terms/estimand/), [mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)](https://nuclide.cc/terms/mcrpc-mhspc/), [Myelosuppression after radioligand therapy](https://nuclide.cc/terms/myelosuppression-after-rlt/), [Salivary gland toxicity (xerostomia) from PSMA radioligand therapy](https://nuclide.cc/terms/salivary-gland-toxicity/)
- roadmaps: [PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha](https://nuclide.cc/roadmaps/psma-theranostics-roadmap/), [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://nuclide.cc/roadmaps/radiopharma-roadmap/)
- key papers: [PSMAfore: 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor in taxane-naive mCRPC](https://nuclide.cc/key-papers/paper-psmafore-lancet-2024/), [VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer](https://nuclide.cc/key-papers/paper-vision-nejm-2021/)
- fronts: [Radioligand therapy](https://nuclide.cc/fronts/f-radioligand-therapy/)
- pairings: [Docetaxel (taxane chemotherapy) then 177Lu-PSMA-617](https://nuclide.cc/pairings/docetaxel-then-lu177-psma/)
- trials: [ENZA-p](https://nuclide.cc/trials/enza-p/)

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