Table 1.
Patient demographics.
| Cohort 1 | Arm A | Exp A | Arm B | Exp B | Arm C | Exp C | All | |
|---|---|---|---|---|---|---|---|---|
| CDS | CDS | CDS | R-SDS | R-SDS | A-SDS | A-SDS | Patients | |
| n (%) | (n = 3) | (n = 10) | (n = 4) | (n = 10) | (n = 3) | (n = 10) | (n = 4) | (N = 44) |
| Median age (range), y | 70.0 (44–70) | 67.5 (41–82) | 67.5 (58–82) | 74.0 (62–78) | 68.0 (68–69) | 67.5 (49–85) | 71.5 (66–72) | 69.0 (41–85) |
| Age ≥ 65 y | 2 (66.7) | 7 (70.0) | 3 (75.0) | 9 (90.0) | 3 (100.0) | 7 (70.0) | 4 (100.0) | 35 (79.5) |
| White race | 2 (66.7) | 9 (90.0) | 1 (25.0) | 8 (80.0) | 1 (33.3) | 7 (70.0) | 3 (75.0) | 31 (70.5) |
| Baseline ECOG | ||||||||
| 0 | 2 (66.7) | 5 (50.0) | 4 (100.0) | 6 (60.0) | 2 (66.7) | 5 (50.0) | 2 (50.0) | 26 (59.1) |
| 1 | 1 (33.3) | 5 (50.0) | 0 | 4 (40.0) | 1 (33.3) | 5 (50.0) | 2 (50.0) | 18 (40.9) |
| Baseline PSA, median (range), μg/L | 21.7 (19–3,051) | 77.7 (4–608) | 154.8 (3–2,027) | 45.1 (6–186) | 55.2 (43–161) | 21.2 (7–365) | 280.7 (40–1,029) | 51.6 (3–3,051) |
| Baseline ALP, median (range), U/L | 75.0 (43–104) | 116.0 (42–284) | 134.5 (56–448) | 98.5 (51–506) | 167.0 (130–488) | 220.0 (36–1,064) | 119.5 (80–313) | 125.0 (36–1,064) |
| Stage at initial diagnosis | ||||||||
| I | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25.0) | 1 (2.3) |
| II | 1 (33.3) | 1 (10.0) | 1 (25.0) | 3 (30.0) | 0 | 1 (10.0) | 0 | 7 (15.9) |
| III | 1 (33.3) | 0 | 0 | 2 (20.0) | 0 | 4 (40.0) | 0 | 7 (15.9) |
| IV | 1 (33.3) | 5 (50.0) | 2 (50.0) | 4 (40.0) | 0 | 2 (20.0) | 2 (50.0) | 16 (36.4) |
| Unknown | 0 | 4 (40.0) | 1 (25.0) | 1 (10.0) | 3 (100.0) | 3 (30.0) | 1 (25.0) | 13 (29.5) |
| Number of bone lesions | ||||||||
| 1–3 | 3 (100.0) | 0 | 1 (25.0) | 4 (40.0) | 0 | 0 | 0 | 8 (18.2) |
| 4–6 | 0 | 2 (20.0) | 0 | 1 (10.0) | 0 | 1 (10.0) | 0 | 4 (9.1) |
| 7–9 | 0 | 1 (10.0) | 0 | 2 (20.0) | 0 | 3 (30.0) | 2 (50.0) | 8 (18.2) |
| ≥ 10 | 0 | 7 (70.0) | 3 (75.0) | 3 (30.0) | 3 (100.0) | 6 (60.0) | 2 (50.0) | 24 (54.5) |
| Prior surgery, n (%) | 1 (33.3) | 6 (60.0) | 4 (100.0) | 8 (80.0) | 3 (100.0) | 9 (90.0) | 3 (75.0) | 34 (77.3) |
| Prior use of taxane, n (%) | 1 (33.3) | 5 (50.0) | 2 (50.0) | 1 (10.0) | 0 | 2 (20.0) | 3 (75.0) | 14 (31.8) |
| Prior radiotherapy, n (%) | 3 (100.0) | 8 (80.0) | 2 (50.0) | 8 (80.0) | 3 (100.0) | 9 (90.0) | 4 (100.0) | 37 (84.1) |
| Max line of therapy, n (%) | ||||||||
| 1 | 3 (100.0) | 5 (50.0) | 1 (25.0) | 2 (20.0) | 3 (100.0) | 2 (20.0) | 1 (25.0) | 17 (38.6) |
| 2 | 0 | 2 (20.0) | 0 | 4 (40.0) | 0 | 2 (20.0) | 2 (50.0) | 10 (22.7) |
| 3+ | 0 | 3 (30.0) | 3 (75.0) | 3 (30.0) | 0 | 4 (40.0) | 0 | 13 (29.5) |
| Missing | 0 | 0 | 0 | 1 (10.0) | 0 | 2 (20.0) | 1 (25.0) | 4 (9.1) |
| Metastatic sites, n (%) | ||||||||
| Adrenal | 1 (33.3) | 1 (10.0) | 0 | 0 | 0 | 4 (40.0) | 0 | 6 (13.6) |
| Bone | 3 (100.0) | 10 (100.0) | 4 (100.0) | 10 (100.0) | 3 (100.0) | 10 (100.0) | 4 (100.0) | 44 (100.0) |
| Liver | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (10.0) | 1 (25.0) | 3 (6.8) |
| Lung | 2 (66.7) | 5 (50.0) | 1 (25.0) | 0 | 0 | 2 (20.0) | 0 | 10 (22.7) |
| Lymph | 3 (100.0) | 7 (70.0) | 3 (75.0) | 10 (100.0) | 2 (66.7) | 7 (70.0) | 4 (100.0) | 36 (81.8) |
| Mediastinum | 0 | 1 (10.0) | 1 (25.0) | 0 | 0 | 0 | 0 | 2 (4.5) |
| Othera | 0 | 5 (50.0) | 1 (25.0) | 6 (60.0) | 1 (33.3) | 3 (30.0) | 1 (25.0) | 17 (38.6) |
Abbreviations: A-SDS, atezolizumab run-in staggered dosing schedule; CDS, concurrent dosing schedule; ECOG, Eastern Cooperative Oncology Group; R-SDS, radium-223 run-in staggered dosing schedule; y, years.
aSoft tissue, retroperitoneal, pleura, soft tissue, peritoneum, bladder, pelvis, chest, prostate, kidney, right ureter, retroperitoneal soft tissue, right periureteral mass, retrocrural node, peritoneum, right perirectal mass, rectum pre-sacral.