ECLIPSE
Curium's PSMA radioligand met its progression endpoint; survival data and an FDA filing are pending.
Overview
ECLIPSE, trial NCT05204927 sponsored by Curium and reported in 2025, tested 177Lu-PSMA-I&T given as six cycles of 7.4 GBq against a switch of androgen receptor pathway inhibitor in PSMA-positive, taxane-naive metastatic castration-resistant prostate cancer after one such inhibitor. It enrolled 439 men and met its primary radiographic progression-free survival endpoint according to the sponsor, with medians pending publication, overall survival maturing, study completion projected for 2029 and an FDA submission plan under discussion. Nuclide links it to prostate cancer and to the 177Lu-PSMA-I&T drug record; its result is consistent with PSMAfore for the pre-chemotherapy setting and contrasts with SPLASH, which used the same ligand but showed an unfavourable interim survival signal. Whether the survival data will support approval of a second lutetium PSMA agent is the open question.
- Numbers are not recorded here for this endpoint. 177Lu-PSMA-I&T: Met per sponsor; medians pending publication; ARPI switch.
- 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 mCRPC after ARPI, taxane-naive: 177Lu-PSMA-I&T (7.4 GBq × 6) vs ARPI switch. 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.
439 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | 177Lu-PSMA-I&T | - | Met per sponsor; medians pending publication | - | - | link |
| ARPI switch | - | - |
Similar pages
not linked directly; found by shared links- TrialSPLASH
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Shares Metastatic castration-resistant prostate cancer, Prostate cancer, Lutetium-177.
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Shares Metastatic castration-resistant prostate cancer, Prostate cancer, Lutetium-177.