A randomised controlled phase 3 trial of lutetium-177-PSMA-617 in taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore)
Abstract
Summary BACKGROUND [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolongs radiographic progression-free survival (rPFS) and overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitor (ARPI) and taxane therapy. PSMAfore is an ongoing phase 3 trial investigating the efficacy of 177Lu-PSMA-617 in patients with taxane-naive mCRPC. METHODS Taxane-naive patients with prostate-specific membrane antigen (PSMA)-positive mCRPC who had progressed once on prior ARPI were randomised 1:1 to open-label intravenous 177Lu-PSMA-617 7·4 GBq (200 mCi) ± 10% once every 6 weeks for six cycles or change of ARPI (to abiraterone or enzalutamide, administered orally on a continuous basis as per product labelling). Crossover from ARPI change to 177Lu-PSMA-617 was allowed after centrally confirmed radiographic progression. The primary endpoint was rPFS. Safety was a secondary endpoint. FINDINGS Overall, 468 patients were randomised to 177Lu-PSMA-617 (n=234) or ARPI change (n=234). Baseline characteristics were generally well balanced between groups. Median number of 177Lu-PSMA-617 cycles was 6 (interquartile range, 2). Of patients randomised to ARPI change, 134 patients (57%) crossed over to receive 177Lu-PSMA-617. In the primary analysis, the hazard ratio (HR) for radiographic progression or death for 177Lu-PSMA-617 vs ARPI change was 0·41 (95% confidence interval [CI], 0·29–0·56; p<0·0001; median rPFS, 9·30 months…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 617 participants or records.
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