VISION
VISION was the trial that established radioligand therapy in prostate cancer.
Overview
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.
- Median 15.3 vs 11.3 months with 177Lu-PSMA-617 + standard care compared with Standard care; about 4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.52 to 0.74).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Median 8.7 vs 3.4 months with 177Lu-PSMA-617 + standard care compared with Standard care; about 5.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 60 percent lower chance of the event at any given time (hazard ratio 0.4, likely range 0.29 to 0.57).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: PSMA+ metastatic castration-resistant prostate cancer after ARPI and taxane: 177Lu-PSMA-617 + SOC vs SOC. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PSMA); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
861 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | 177Lu-PSMA-617 + standard care | 551 | 15.3 months | 0.62 (0.52 to 0.74) | <0.001 | link |
| Standard care | 280 | 11.3 months | ||||
| Radiographic progression-free survivalprimary | 177Lu-PSMA-617 + standard care | - | 8.7 months | 0.4 (0.29 to 0.57) | <0.001 | link |
| Standard care | - | 3.4 months |
For men who still have a working hormone treatment option but whose cancer is progressing, offering the PSMA radioligand therapy sooner - before chemotherapy - delayed disease progression, though it did not clearly extend how long men lived once the very high rate of patients switching over is accounted for.
For men whose prostate cancer has grown after chemotherapy, a PSMA-targeted radioactive treatment worked at least as well as, and was gentler than, the chemotherapy drug it replaced - provided a PET scan first confirms the cancer takes up the PSMA tracer.
Men with metastatic castration-resistant prostate cancer that has progressed after hormonal therapy and chemotherapy, and whose tumours show PSMA on a PET scan, can now receive lutetium-PSMA, which extends life, controls pain and is usually better tolerated than further chemotherapy. It has established a new treatment class in which a scan decides who gets the matching radioactive drug, and it is now being tested earlier in the disease (PSMAfore, PSMAddition).
In a small early trial, most heavily pre-treated men with advanced prostate cancer responded to the PSMA-targeted radioactive drug, with manageable side effects, supporting the case for testing it in larger randomised trials.
Similar pages
not linked directly; found by shared links- TrialPSMAfore
Shares Estimands and intercurrent events (ICH E9(R1)), Crossover in trials, Salivary gland toxicity (xerostomia) from PSMA radioligand therapy, mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer).
- TrialTheraP (ANZUP 1603)
Shares Crossover in trials, Adding a checkpoint inhibitor to PSMA radioligand therapy, LuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer, TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer.
- PersonMichael Hofman
Shares LuPSMA trial: single-arm phase 2 study of 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer, TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer, PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha, PSMA.
- PersonShahneen Sandhu
Shares Adding a checkpoint inhibitor to PSMA radioligand therapy, TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer, PSMA, Lutetium-177 vipivotide tetraxetan.
- Agent177Lu-PSMA-I&T
Shares Salivary gland toxicity (xerostomia) from PSMA radioligand therapy, PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha, Metastatic castration-resistant prostate cancer, PSMA.
- PersonLouise Emmett
Shares TheraP: [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer, PSMA, Lutetium-177 vipivotide tetraxetan, PSMA PET.
- PairingPSMA PET → PSMA radioligand therapy
Shares VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer, PSMA, Lutetium-177 vipivotide tetraxetan, PSMA PET.
- AgentGallium-68 gozetotide (PSMA-11)
Shares PSMA-RADS (PSMA reporting and data system), Locametz (kit for Ga-68 gozetotide), PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha, PSMA.