Comparison of 223Ra and 177Lu-PSMA-617 Phase III Trial Designs
| 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.