VISION trial — Lu-177 PSMA therapy for prostate cancer
Who was studied
831 men with PSMA-positive metastatic castration-resistant prostate cancer who had already received hormone therapy (ARPI) and chemotherapy.
What they did
Randomly assigned 2:1 to Lu-177 PSMA therapy + standard care, or standard care alone. Standard care was investigator-chosen (typically hormone therapy, abiraterone, enzalutamide).
What they found
Citation: Sartor O et al. NEJM 2021;385:1091.
NETTER-1 trial — Lu-177 DOTATATE therapy for NETs
Who was studied
229 patients with advanced somatostatin-receptor-positive midgut neuroendocrine tumors that progressed despite first-line octreotide therapy.
What they did
Randomized to Lu-177 DOTATATE therapy + 30 mg octreotide LAR, or high-dose 60 mg octreotide LAR alone.
What they found
Citation: Strosberg J et al. NEJM 2017;376:125.
NETTER-2 trial — Lu-177 DOTATATE therapy as first-line
Phase 3 trial published 2024. Studied Lu-177 DOTATATE therapy + octreotide vs high-dose octreotide alone in newly diagnosed Grade 2 and Grade 3 GEP-NETs.
Lu-177 DOTATATE therapy-treated patients had a median PFS of 22.8 months vs 8.5 months on control — a more than 3× improvement. This trial is shifting Lu-177 DOTATATE therapy earlier in NET treatment.
PSMAfore trial — Lu-177 PSMA therapy earlier in prostate cancer
Phase 3 trial published 2024. Studied Lu-177 PSMA therapy in men with mCRPC who had progressed on ARPI but had NOT received chemotherapy. Lu-177 PSMA therapy was compared to a switch to a different ARPI.
Lu-177 PSMA therapy produced significantly longer rPFS (median 12 months vs 5.6 months) — leading FDA in 2025 to expand the Lu-177 PSMA therapy label to include this earlier population.
What about real-world data?
Outside of trials, registries and observational studies of Lu-177 DOTATATE therapy and Lu-177 PSMA therapy have largely confirmed trial results. Some patterns emerging:
- Earlier intervention (before extensive chemotherapy exposure) tends to produce longer benefit
- Strong receptor expression on scan correlates with better response
- Patient performance status matters: those who start with ECOG 0–1 do better than those starting with ECOG 2