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PSMAfore

PSMAfore moved Pluvicto before chemotherapy in prostate cancer.

rPFS HR 0.41; OS confounded by 84% crossover. Approved 2025 in pre-chemotherapy setting.

Setting
PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 vs ARPI switch
Phase
Phase 3
Sponsor
Novartis
Registry
Headline result
rPFS HR 0.41.
Reported
2023
Enrolled
468
Replication
Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter.

Outcomes

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In plain words
What these results mean for people, not percentages
468 people took part
Radiographic progression-free survivalprimarysurrogate endpoint
  • Median 12 vs 5.6 months with 177Lu-PSMA-617 compared with ARPI switch; about 6.4 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 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.29 to 0.56).
  • 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.
Overall survival (crossover-adjusted)survival endpoint
  • The treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • Unadjusted OS HR 0.98 with 84% crossover from control
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • Unadjusted OS HR 0.98 with 84% crossover from control.
Be careful
  • These results apply to the people the trial enrolled: PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 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.

468 participants enrolled.

Radiographic progression-free survivalprimary
HR 0.41 (0.29–0.56) · p <0.0001
177Lu-PSMA-617
12 mo
ARPI switch
5.6 mo
Source
Overall survival (crossover-adjusted)
HR 0.59

Unadjusted OS HR 0.98 with 84% crossover from control

Source
EndpointArmnValueHR (95% CI)pSource
Radiographic progression-free survivalprimary177Lu-PSMA-61723412 months0.41 (0.29–0.56)<0.0001link
ARPI switch2345.6 months
Overall survival (crossover-adjusted)177Lu-PSMA-617Unadjusted OS HR 0.98 with 84% crossover from control0.59link
ARPI switch
Replication
Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter.

Key papers

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Connected

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