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PSMAfore, trial NCT04689828 sponsored by Novartis and published in the Lancet in 2024, moved Pluvicto, or 177Lu-PSMA-617, before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer after one androgen receptor pathway inhibitor. It randomised 468 taxane-naive men to the radioligand or a switch of androgen receptor pathway inhibitor, met its primary radiographic progression-free survival endpoint with a large effect, and overall survival was confounded by crossover of most control patients, with crossover-adjusted analyses favouring the radioligand; approval in the pre-chemotherapy setting followed in 2025. Whether earlier use improves survival, not just progression, is the open question.
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.
469 enrolled.
Unadjusted OS HR 0.98 with 84% crossover from control
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | 177Lu-PSMA-617 | 234 | 12 months | 0.41 (0.29 to 0.56) | <0.0001 | link |
| ARPI switch | 234 | 5.6 months | ||||
| Overall survival (crossover-adjusted) | 177Lu-PSMA-617 | - | Unadjusted OS HR 0.98 with 84% crossover from control | 0.59 | - | link |
| ARPI switch | - | - |
This is the paper Europe PMC returns for registry id NCT04689828 with the most citations, so it is the natural first reading for anyone following the PSMAfore trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
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).
Shares Total-body PET for personalised radioligand dosing, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters), Novartis.
Shares A. Oliver Sartor, VISION, What follows what in castration-resistant prostate cancer, Metastatic castration-resistant prostate cancer.
Shares Total-body PET for personalised radioligand dosing, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters), Novartis.
Shares VISION, VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters).
Shares CARD, mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer), What follows what in castration-resistant prostate cancer, Metastatic castration-resistant prostate cancer.
Shares TheraP (ANZUP 1603), VISION: lutetium-177 PSMA-617 radioligand therapy extends survival in advanced prostate cancer, Radioligand therapy (beta emitters), Metastatic castration-resistant prostate cancer.
Shares VISION, Lutetium-177 vipivotide tetraxetan, Radioligand therapy (beta emitters), Novartis.
Shares Lutetium-177 vipivotide tetraxetan, Novartis, Metastatic castration-resistant prostate cancer, Prostate cancer.