Top Line: Can Pluvicto delay the need for ADT in men with oligometastatic, hormone sensitive prostate cancer with rapid PSA progression?
The Study: BULLSEYE was a phase 2 Dutch trial that included 58 patients who had biochemical recurrence after primary surgery or radiation (not amenable to further surgery or radiation), a PSA >1, a PSA doubling time < 6 months, and oligometastatic disease on PSMA PET. They were randomized to undergo observation (no therapy) or receive Pluvicto. Neither arm received ADT. The latter group received 2 initial cycles every 6 weeks with 2 additional cycles if there was residual PSMA positive disease. At 30 weeks, only 7% of the treatment group had progressed versus 93% of controls. Median PFS was 25 months versus 5 months. The rate of complete biochemical response was 24%, and 83% of patients had at least a 50% drop in their PSA. Median time to next systemic therapy was 26 versus 6 months. Adverse events were mild with mostly grade 1 dry mouth (66%), fatigue (55%), and nausea (48%), with no grade 4 treatment-related events. HRQoL was maintained throughout. Importantly, 93% of control patients crossed over to receive Pluvicto upon progression, which limits survival comparisons. The inclusion criteria selected for high-PSMA-expressing, rapidly progressing disease, which may be the ideal population for this approach but limits generalizability.
TBL: In a carefully selected population of patients with oligometastatic HSPC not amenable to local therapy, Pluvicto delayed progression and time to starting ADT. | Prive, Lancet Oncol 2026
The Study: BULLSEYE was a phase 2 Dutch trial that included 58 patients who had biochemical recurrence after primary surgery or radiation (not amenable to further surgery or radiation), a PSA >1, a PSA doubling time < 6 months, and oligometastatic disease on PSMA PET. They were randomized to undergo observation (no therapy) or receive Pluvicto. Neither arm received ADT. The latter group received 2 initial cycles every 6 weeks with 2 additional cycles if there was residual PSMA positive disease. At 30 weeks, only 7% of the treatment group had progressed versus 93% of controls. Median PFS was 25 months versus 5 months. The rate of complete biochemical response was 24%, and 83% of patients had at least a 50% drop in their PSA. Median time to next systemic therapy was 26 versus 6 months. Adverse events were mild with mostly grade 1 dry mouth (66%), fatigue (55%), and nausea (48%), with no grade 4 treatment-related events. HRQoL was maintained throughout. Importantly, 93% of control patients crossed over to receive Pluvicto upon progression, which limits survival comparisons. The inclusion criteria selected for high-PSMA-expressing, rapidly progressing disease, which may be the ideal population for this approach but limits generalizability.
TBL: In a carefully selected population of patients with oligometastatic HSPC not amenable to local therapy, Pluvicto delayed progression and time to starting ADT. | Prive, Lancet Oncol 2026