Table 5.

Summary of efficacy of 177Lu-PSMA RLT in large-scale clinical studies

References	Year	Study design	Radioligand	Patient characteristics	TEAE	Response	Survival
Rahbar et al (20)	2017	Retrospective, 12 centers, Germany	177Lu- PSMA-617 2–8 GBq/cycle Total 248 cycles	PSMA-avid mCRPC, 145 patients (median age 73 years) Prior Tx: AA 64%, ENZ 52%, CTx 54%, 223Ra 17% Mets: bone 87%, LN 77%, liver 20%, lung 14%	Grade 1/2 Xerostomia 8%, Nausea 6% Grade 3/4 Anemia 10%, Thrombocytopenia 4% Leukopenia 3%	PSA decline ≥50%, 45% PSA response Good: ≥3 cycles Bad: visceral mets, elevated ALP	NA
Heck et al. (31)	2019	Retrospective, single-center, Germany	177Lu- PSMA-I&T 7.4 GBq/cycle Every 6–8 weeks Total 319 cycles	PSMA-avid mCRPC, 100 patients Prior Tx ≥3 regimens 57% Mets: bone 96%, LN 87%, viscera 35%	Grade 1/2 Xerostomia 24% Fatigue 20% Loss of appetite 10% Diarrhea 7% Grade 3/4 Anemia 9% Thrombocytopenia 4% Neutropenia 6%	PSA decline ≥30%, 47% ≥50%, 38% ≥90%, 11%	Median PFS 4.1 months Median OS 12.9 months Prognostic factors Good: PSA decline≥50% Bad: visceral mets, rising LDH

Abbreviations: PSMA, prostate-specific membrane antigen; RLT, radioligand therapy; TEAE, treatment-emergent adverse events; mCRPC, metastatic castration-resistant prostate cancer; Tx, therapy; AA, abiraterone acetate; ENZ, enzalutamide; CTx, chemotherapy; mets, metastases; LN, lymph node; ALP, alkaline phosphatase; NA, not available; PFS, progression-free survival; OS, overall survival.