PSMAddition
PSMAddition moved the radioligand Pluvicto into the first treatment of metastatic hormone-sensitive prostate cancer, given alongside hormone therapy, and the FDA approved this use on 31 July 2026. It delayed progression on scans, but severe side effects were more common and whether it lengthens life is not yet known.
Overview
PSMAddition, trial NCT04720157 sponsored by Novartis and reported in 2025, moved Pluvicto, or 177Lu-PSMA-617, into the first-line treatment of metastatic prostate cancer, and the FDA approved this use on 31 July 2026. It randomised 1,144 men with PSMA-positive metastatic hormone-sensitive disease to the radioligand plus androgen deprivation and an androgen receptor pathway inhibitor or to standard care alone, and met its primary radiographic progression-free survival endpoint at ESMO 2025 with a stronger effect at update, while overall survival trended favourably but remained immature and severe adverse events were more common. Nuclide links it to radioligand therapy, the CRPC term and the idea of alpha-emitting PSMA therapy at first diagnosis. Whether early radioligand use improves survival or only delays progression is the open question.
- 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 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 to 0.89) | 0.0016 | link |
| Standard care | - | - |
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