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TheraP

[177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer: a randomised, open-label, phase 2 trial

Phase 2N = 200NCT03392428

Population
Men with metastatic castration-resistant prostate cancer for whom cabazitaxel was considered the next appropriate standard treatment; 291 were screened and 200 were eligible on PET and randomised
Design
Multicentre, unblinded, randomised (1:1) phase 2 trial at 11 centres in Australia of [177Lu]Lu-PSMA-617 (6.0-8.5 GBq every 6 weeks for up to six cycles) versus cabazitaxel (20 mg/m2 every 3 weeks for up to ten cycles). Eligibility required PSMA-positive disease on 68Ga-PSMA-11 PET and no discordant FDG-positive, PSMA-negative disease. The primary endpoint was PSA response (a fall of at least 50% from baseline).
Primary endpoint
PSA response rate
Arms
  • [177Lu]Lu-PSMA-617 (experimental, n = 99): [177Lu]Lu-PSMA-617 6.0-8.5 GBq intravenously every 6 weeks for up to six cycles
  • Cabazitaxel (control, n = 101): Cabazitaxel 20 mg/m2 intravenously every 3 weeks for up to ten cycles
People
Hofman MS
Δ PSA response rate+29 points
Show the numbers
Results reported for TheraP
EndpointAnalysis[177Lu]Lu-PSMA-617CabazitaxelEffect
PSA response ratePSA reduction of at least 50% from baselineprimaryHofman 202166%37%P<0.000165 vs 37 PSA responses; difference 29% (95% CI 16 to 42). By treatment received: 66% vs 44%, difference 23% (95% CI 9 to 37), p=0.0016.
Results reported for TheraP
EndpointAnalysis[177Lu]Lu-PSMA-617CabazitaxelEffect
PSA response ratePSA reduction of at least 50% from baselineprimaryHofman 202166%37%P<0.000165 vs 37 PSA responses; difference 29% (95% CI 16 to 42). By treatment received: 66% vs 44%, difference 23% (95% CI 9 to 37), p=0.0016.
Primary publication: Hofman MS, Emmett L, Sandhu S, Iravani A, Joshua AM, Goh JC, et al. [(177)Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021;397(10276):797-804. PubMedDOI

Appears in

Sources

  1. Hofman MS, Emmett L, Sandhu S, Iravani A, Joshua AM, Goh JC, et al. [(177)Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet. 2021;397(10276):797-804.

    PubMedDOI