PSMAddition
Moved Pluvicto to the very first treatment of metastatic prostate cancer; FDA approved this use on 31 July 2026.
1,144 men (50% de novo, 68% high volume); rPFS HR 0.72 at primary analysis (ESMO 2025), 0.67 at update; OS trend HR 0.80 (immature); grade ≥3 AEs 50.7% vs 43.0%. FDA approval 31 July 2026 for 'metastatic androgen pathway modulation-naive or -sensitive' disease with an ARPI.
- The treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- Updated HR 0.67; OS HR 0.80, immature
- 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-positive metastatic hormone-sensitive prostate cancer: 177Lu-PSMA-617 + ADT + ARPI vs ADT + ARPI. 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.
- Updated HR 0.67; OS HR 0.80, immature.
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.
1,144 participants enrolled.
Updated HR 0.67; OS HR 0.80, immature
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | 177Lu-PSMA-617 + standard care (ARPI + ADT) | — | Updated HR 0.67; OS HR 0.80, immature | 0.72 (0.58–0.89) | 0.0016 | link |
| Standard care | — | — |
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