Table 1.
Baseline patient characteristics in selected randomized phase 2 and 3 studies of 177Lu-PSMA-617 in progressive PSMA-positive mCRPC.
| TheraP [23] | VISION [24] | PSMAfore [27] | ||||
|---|---|---|---|---|---|---|
| Study type | Phase 2 | Phase 3 | Phase 3 | |||
| PSMA PET eligibility criteria | 68Ga-PSMA-11, SUVmax ≥ 20 at ≥1 disease site and >10 at all other metastatic disease sites | 68Ga-PSMA-11 uptake greater than liver parenchyma at ≥1 disease site and no PSMA-negative metastatic lesions | 68Ga-PSMA-11 uptake greater than liver parenchyma at ≥1 disease site and no PSMA-negative metastatic lesions | |||
| FDG PET eligibility criteria | No sites with discordant FDG-positive/PSMA-negative lesions | N/A | N/A | |||
| Study arms | LuPSMA | Cabazitaxel | LuPSMA | SOC | LuPSMA | ARPI change |
| Patients, n | 99 | 101 | 551 | 280 | 234 | 234 |
| Median age, years | 72.1 | 71.8 | 70.0 | 71.5 | 71 | 72 |
| ECOG PS 0 or 1, % | 96 | 96 | 92.6 | 92.1 | 99.1 | 97.9 |
| Median PSA level, μg/L | 93.5 | 110 | 77.5 | 74.6 | 18.4 | 14.9 |
| Median ALP level, IU/L | 111 | 130 | 105.0 | 94.5 | 100.0 | 103.5 |
| Disease sites, % | ||||||
| Bone | 90.9 | 89.1 | 91.5 | 91.4 | 87.6 | 86.8 |
| Liver | 7.11 1 | 12.91 1 | 11.4 | 13.6 | 5.6 | 3.0 |
| Lymph node | 52.5 | 46.5 | 49.7 | 50.4 | 32.5 | 31.6 |
| Previous treatments, % | ||||||
| ARPI | 92 | 90 | 100 | 100 | 100 | 100 |
| Cabazitaxel | 0 | 0 | 37.9 | 38.2 | 0 | 0 |
| Docetaxel | 100 | 100 | 96.9 | 97.5 | 0 | 0 |
1 Includes all visceral disease sites (lung, liver, and other), not just liver. 68Ga, gallium-68; 177Lu, lutetium-177; ALP, alkaline phosphatase; ARPI, androgen receptor pathway inhibitor; ECOG, Eastern Cooperative Oncology Group; FDG, fluorodeoxyglucose; LuPSMA, 177Lu-PSMA-617; mCRPC; metastatic castration-resistant prostate cancer; N/A, not applicable; PET, positron emission tomography; PS, performance status; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; SOC, standard of care; SUVmax, maximum standard uptake value.