177Lu-PSMA-617 is a targeted radioligand therapy (lutetium-177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer. It is marketed as Pluvicto and delivers beta-emitting radiation to PSMA-expressing tumor cells. The therapy is approved in major markets including the United States.
Phase 3 PSMAddition showed that adding 177Lu-PSMA-617 to ADT plus an ARPI improved radiographic progression-free survival in PSMA-positive mHSPC. Health-related quality of life and pain were largely maintained.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
Pluvicto (lutetium-177 vipivotide tetraxetan) received MHRA authorization for earlier use in metastatic castration-resistant prostate cancer, while pooled trial data demonstrates improved progression-free survival without increased toxicity.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07223034 |
A Study of 177Lu-PSMA-617 in People With Gliomas |
RECRUITING | PHASE1 |
| NCT07145177 |
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer |
RECRUITING | PHASE1 |
| NCT07025512 |
177Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) With Bone Marrow Involvement and Cytopenia |
WITHDRAWN | PHASE2 |
| NCT06964958 |
177LuPSMA in Renal Cell Carcinoma |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06943495 |
Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2) |
RECRUITING | PHASE1 |
| NCT06783348 |
Radiopharmaceutical Treatment of Advanced Kidney Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT06461689 |
Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer |
COMPLETED | |
| NCT06329830 |
177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer |
WITHDRAWN | PHASE1/PHASE2 |
| NCT06303713 |
LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT05766371 |
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer |
RECRUITING | PHASE2 |
