# VISION

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

## TL;DR

VISION was the trial that established radioligand therapy in prostate cancer.

## Summary

VISION, trial NCT03511664 sponsored by Novartis and published in the New England Journal of Medicine in 2021, was the trial that established radioligand therapy in prostate cancer. It randomised 831 men with PSMA-positive metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane to 177Lu-PSMA-617 plus standard care or standard care alone, selected by PSMA PET, and met both primary endpoints of overall and radiographic progression-free survival. Whether radioligand therapy should now be given before chemotherapy or even at diagnosis, as PSMAfore and PSMAddition test, is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT03511664
- Phase: 3
- Setting: PSMA+ metastatic castration-resistant prostate cancer after ARPI and taxane: 177Lu-PSMA-617 + SOC vs SOC
- Sponsor: Novartis
- Enrolled: 861
- Result: OS HR 0.62.
- Outcomes: Overall survival: 177Lu-PSMA-617 + standard care 15.3 months vs Standard care 11.3 months, HR 0.62; Radiographic progression-free survival: 177Lu-PSMA-617 + standard care 8.7 months vs Standard care 3.4 months, HR 0.4
- Replication: Consistent with TheraP (phase 2, 177Lu-PSMA-617 vs cabazitaxel: higher PSA response, similar OS) and with PSMAfore in an earlier line.

## Notes

- In England NICE TA930 does not recommend lutetium-177 vipivotide tetraxetan, within its marketing authorisation, for PSMA-positive hormone-relapsed metastatic prostate cancer after taxane-based chemotherapy and an anti-androgen, or when taxanes are medically unsuitable. The committee noted that treatments at this stage include best supportive care and retreatment with taxanes such as cabazitaxel, that some men are eligible for radium-223 dichloride, and that no evidence was submitted comparing lutetium-177 vipivotide tetraxetan with radium-223 so that comparison could not be considered. It accepted that the radioligand increases both time to progression and overall survival against best supportive care. This is the widest gap between marketing authorisation and NHS funding in prostate cancer.

## Sources

- ClinicalTrials.gov NCT03511664: https://clinicaltrials.gov/study/NCT03511664
- NICE TA930: lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments, not recommended: https://www.nice.org.uk/guidance/ta930

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PSMA PET](https://onco.cc/technologies/psma-pet/), [Radioligand therapy (beta emitters)](https://onco.cc/technologies/radioligand-therapy/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- drugs: [Locametz (kit for Ga-68 gozetotide)](https://onco.cc/drugs/locametz/), [Lutetium-177 vipivotide tetraxetan](https://onco.cc/drugs/pluvicto/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- terms: [Crossover in trials](https://onco.cc/terms/crossover/), [Estimands and intercurrent events (ICH E9(R1))](https://onco.cc/terms/estimand/), [mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)](https://onco.cc/terms/mcrpc-mhspc/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [Radiographic progression-free survival (rPFS)](https://onco.cc/terms/radiographic-progression-free-survival/), [What follows what in castration-resistant prostate cancer](https://onco.cc/terms/prostate-crpc-sequencing/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)
- trials: [ALSYMPCA](https://onco.cc/trials/alsympca/), [CARD](https://onco.cc/trials/card/), [PEACE-3 (EORTC 1333)](https://onco.cc/trials/peace-3/), [PSMAfore](https://onco.cc/trials/psmafore/), [TheraP (ANZUP 1603)](https://onco.cc/trials/therap/)
- people: [A. Oliver Sartor](https://onco.cc/people/oliver-sartor/), [Ken Herrmann](https://onco.cc/people/ken-herrmann/), [Michael J. Morris](https://onco.cc/people/michael-morris/)
- key papers: [VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer](https://onco.cc/key-papers/paper-vision-nejm-2021/)
- roadmaps: [Radiopharmaceutical roadmap: iodine → lutetium → actinium](https://onco.cc/roadmaps/radiopharma-roadmap/)
- ideas: [Total-body PET for personalised radioligand dosing](https://onco.cc/ideas/idea-total-body-pet-dosimetry/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- institutions: [West German Cancer Center (WTZ), University Hospital Essen](https://onco.cc/institutions/essen-wtz/)

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JSON: https://onco.cc/api/v1/entities/vision.json