VISION
VISION was the trial that established radioligand therapy in prostate cancer.
OS 15.3 vs 11.3 months (HR 0.62); rPFS HR 0.40. Selection by PSMA PET.
Setting
PSMA+ metastatic castration-resistant prostate cancer after ARPI and taxane: 177Lu-PSMA-617 + SOC vs SOC
Phase
Phase 3
Sponsor
Novartis
Registry
Headline result
OS HR 0.62.
Reported
2021
Enrolled
831
Replication
Consistent with TheraP (phase 2, 177Lu-PSMA-617 vs cabazitaxel: higher PSA response, similar OS) and with PSMAfore in an earlier line.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- 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.
Radiographic progression-free survivalprimarysurrogate endpoint
- 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.
Be careful
- 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.
831 participants enrolled.
Overall survivalprimary
HR 0.62 (0.52–0.74) · p <0.001
177Lu-PSMA-617 + standard care
15.3 mo
Standard care
11.3 mo
Radiographic progression-free survivalprimary
HR 0.4 (0.29–0.57) · p <0.001
177Lu-PSMA-617 + standard care
8.7 mo
Standard care
3.4 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | 177Lu-PSMA-617 + standard care | 551 | 15.3 months | 0.62 (0.52–0.74) | <0.001 | link |
| Standard care | 280 | 11.3 months | ||||
| Radiographic progression-free survivalprimary | 177Lu-PSMA-617 + standard care | — | 8.7 months | 0.4 (0.29–0.57) | <0.001 | link |
| Standard care | — | 3.4 months |
Replication
Consistent with TheraP (phase 2, 177Lu-PSMA-617 vs cabazitaxel: higher PSA response, similar OS) and with PSMAfore in an earlier line.