[177Lu]-PSMA-617-PSMA-617 in oligometastatic hormone sensitive prostate cancer (BULLSEYE): an open-label, randomised, phase 2 study - PubMed
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- The BULLSEYE study was a phase 2, open-label, randomized trial evaluating [177Lu]Lu-PSMA-617 in patients with oligometastatic hormone-sensitive prostate cancer (HSPC).
- A total of 58 eligible patients were randomized to receive either two to four cycles of 7.4 GBq 177Lu-PSMA-617 (intervention group) or standard of care with deferred androgen deprivation therapy (control group).
- At a median follow-up of 27 months, only 7% of patients in the intervention group experienced disease progression within the first 30 weeks, compared to 93% in the control group, with a highly significant difference (p<0.0001).
- The median progression-free survival was 25 months in the intervention group versus 5 months in the control group, with a hazard ratio of 0.07 (95% CI 0.03-0.17).
- Treatment-related adverse events in the 177Lu-PSMA-617 group were mostly low-grade, including dry mouth, fatigue, and nausea; no treatment-related serious adverse events or deaths were reported.
- The study concluded that 177Lu-PSMA-617 showed promising efficacy in delaying disease progression with a manageable safety profile in oligometastatic HSPC.