Overview of Current Data on Compassionate Use of 225Ac-PSMA-617 RLT in Different Patient Cohorts: Effects of Treatment on PSA, Complete Remission in PET, and Median OS Are Summarized (34)
| Cohort | Pretoria I | Pretoria II | Heidelberg | New Delhi | TUM | LMU | Pretoria III |
|---|---|---|---|---|---|---|---|
| Chemo-naïve mHSPC/mCRPC | Early mCRPC | Intermediate mCRPC (7/40 after LuPSMA) | Early to intermediate | Late mCRPC (all after LuPSMA) | Early to intermediate mCRPC | mCRPC directly after ADT | |
| n | 17 | 73 | 40 | 28 | 26 | 18 (4 excluded because of incomplete follow-up) | 53 |
| 225Ac-PSMA-617 | 225Ac-PSMA-617 | 225Ac-PSMA-617 | 225Ac-PSMA-617 | 225Ac-PSMA-617 | 225Ac-PSMA-I&T | 225Ac-PSMA-617 | |
| Prior mCRPC lines | (no CTx, no second ADT, 3× LuPSMA) | 1–2 | Median, 3 (range, 1–7) | (15 prior LuPSMA, 13 no LuPSMA) | Median, 6 (range, 3–8) (all after LuPSMA) | Median, 3 (range, 2–4) 11/14 after LuPSMA | 1 (ADT) |
| Any PSA ↓ | 94% (16/17) | 83% (60/73) | 93% (37/40) | 79% (22/28) | 88% (23/26) | 79% (11/14) | 96% (51/53) |
| Max. ≥50% PSA ↓ | 88% (15/17) | 70% (51/73) | 75% (30/40) | 39% (11/28) | 65% (17/26) | 50% (7/14) | 91% (48/53) |
| Max. ≥90% PSA ↓ | 82% (14/17) | 58%* (42/73) | 40%* (16/40) | 14% (4/28)* | 12% (3/26) | 7% (1/14)* | NA |
| CR on PET | 65% (11/17) | 29% (21/73) | NA | 2/22 (9%) | 0% | NA | 56% (30/54) |
| Median cPFS | NA | 15.2 mo (est.) | 7 mo | 12 mo | 4.1 mo | NA | 22 mo†; 4 mo‡ |
| Median OS | NA | 18 mo (est.) | >12 mo | 17 mo | 7.7 mo | NA | NA†; 9 mo‡ |
| Publication | (32) | (33) | (31) | (35) | (34) | (28) | (61) |
↵* Extracted from waterfall plot.
↵† Patients with PSA decline ≥ 50%.
↵‡ Patients with PSA decline < 50%.
TUM = Technische Universität München; LMU = Ludwig-Maximilians-Universität München; mHSPC = metastatic hormone-sensitive prostate cancer; ADT = androgen deprivation therapy; CTx = chemotherapy; max = maximum; NA = not available; CR = complete remission; est. = estimated.