Article Figures & Data
Figures
- FIGURE 1.
Overview of FDA process for new drug approval (19).
- FIGURE 2.
Trials assessing 177Lu-PSMA-617 therapy in various stages of PCa.
Tables
Type of review ALSYMPCA (43) VISION (57) Therapeutic agent 223Ra 177Lu-PSMA-617 Patient eligibility Progressive CRPC; 2 or more bone metastases based on bone scintigraphy with no visceral metastases; previous docetaxel or docetaxel-ineligible Progressive metastatic CRPC; PSMA-positive disease, based on PSMA-PET; 1 or more androgen receptor inhibitors; previous taxane chemotherapy (1 or 2 agents) Treatment arm 223Ra (50 kBq/kg), up to 6 doses every 4 wk 177Lu-PSMA-617 (7.4 GBq), up to 4 cycles every 6 wk Control arm Standard of care: for example, antiandrogens, excluding concurrent use of chemotherapy, EBRT, systemic radionuclides Standard of care: for example, antiandrogens, excluding concurrent use of chemotherapy, EBRT, systemic radionuclides, immunotherapy Primary endpoints Overall survival Overall survival; rPFS Secondary endpoints Total ALP (time to increase, total ALP response); time to PSA increase; time to first symptomatic skeletal event (first use of EBRT for skeletal symptoms or new symptomatic pathologic fracture, spinal cord compression or tumor-related orthopedic intervention) Objective response and disease control (RECIST); time to first symptomatic skeletal event (first use of EBRT for skeletal symptoms or new symptomatic pathologic fracture, spinal cord compression or tumor-related orthopedic intervention) FDA-approved indications CRPC with symptomatic bone metastases and no visceral metastases PSMA-positive metastatic CRPC, previous treatment with androgen receptor pathway inhibition and taxane-based chemotherapy ALP = alkaline phosphatase; EBRT = external-beam radiotherapy.
Trial name ClinicalTrials.gov number Phase Size (n) Regimen Geographic region High-risk localized or oligometastatic PCa Lutectomy NCT04430192 II 20 177Lu-PSMA-617 before prostatectomy Australia Bullseye NCT04443062 II 58 177Lu-PSMA-617 vs. standard of care The Netherlands PROQURE-1 NCT05162573 I 18 EBRT + 177Lu-PSMA-617 The Netherlands Metastatic CRPC UpFrontPSMA NCT04343885 II 140 Docetaxel ± 177Lu-PSMA-617 Australia ProstACT TARGET NCT05146973 II 50 EBRT + 177Lu-DOTA-TLX591 Australia PSMAddition NCT04720157 III 1,126 Standard of care ± 177Lu-PSMA-617 United States, Europe, Korea, Singapore, Taiwan NA NCT04206319 II 26 223Ra United States NA NCT05079698 I 6 177Lu-PSMA-617 + stereotactic radiotherapy United States First-line therapy for metastatic CRPC EnzaP NCT04419402 II 160 Enzalutamide ± 177Lu-PSMA-617 Australia PSMAfore NCT04689828 III 450 177Lu-PSMA-617 vs. change in ARSI North America, Europe Second-line therapy for metastatic CRPC LuPARP NCT03874884 I 52 177Lu-PSMA-617 + olaparib Australia PRINCE NCT03658447 I/II 37 177Lu-PSMA-617 + pembrolizumab Australia NA NCT03805594 I 43 177Lu-PSMA-617 + pembrolizumab United States NA NCT04946370 I/II 76 225Ac-J591 + pembrolizumab United States SPLASH NCT04647526 III 415 177Lu-PSMA-I&T vs. second-line ARSI North America, Europe NA NCT04506567 I/II 105 225Ac-J591 United States ARROW NCT03939689 II 120 Enzalutamide ± MIP 1095 131I North America NA NCT04644770 I 70 225Ac h11B6 United States SECuRE NCT04868604 I/II 44 64Cu-SAR-bisPSMA United States LuCAB NCT05340374 I/II 44 177Lu-PSMA-617 + cabazitaxel Australia NA NCT04071236 I/II 24 223Ra ± M3814 ± avelumab United States TATCIST NCT05219500 II 100 225Ac-PSMA-I&T United States NA NCT04886986 I/II 33 225Ac + 177Lu-PSMA-I&T United States ECLIPSE NCT05204927 III 400 177Lu-PSMA-I&T United States NA NCT04597411 I 30 225Ac-PSMA-617 Australia, South Africa PROSTACT NCT04876651 III 387 177Lu-J591 Australia EBRT = external beam radiotherapy; ARSI = androgen receptor signaling inhibitor; NA = not applicable.
