Table 1.
Baseline demographics and characteristics
| BCR (N=35) | mCRPC (N=56) | Total (N=91) | |
| Mean (range) age, years | 67.4 (52–79) | 70.1 (54–88) | 69.1 (52–88) |
| Race, n (%) | |||
| White | 32 (91.4) | 47 (83.9) | 79 (86.8) |
| Black | 3 (8.6) | 8 (14.3) | 11 (12.1) |
| Asian | 0 (0.0) | 1 (1.8) | 1 (1.1) |
| ECOG PS, n (%) | |||
| 0 | 34 (97.1) | 35 (62.5) | 69 (75.8) |
| 1 | 1 (2.9) | 21 (37.5) | 22 (24.2) |
| Median (range) Gleason score | 7.0 (4–9) | 8.0 (6–10) | 7.0 (4–10) |
| Measurable disease | N=35 | N=54 | N=89 |
| Yes | 0 (0.0) | 24 (44.4) | 24 (27.0) |
| No | 35 (100) | 30 (55.6) | 65 (73.0) |
| Median (range) local PSA, ng/mL | 2.8 (0.5–20.6) | 16.2 (0.7–1500.0) | 6.7 (0.5–1500.0) |
| Prior surgery, n (%) | 31 (88.6) | 38 (67.9) | 69 (75.8) |
| Prior radiation therapy, n (%) | 27 (77.1) | 37 (66.1) | 64 (70.3) |
| Prior systemic therapy, n (%) | 19 (54.3) | 56 (100.0) | 75 (82.4) |
| Abiraterone | 1 (2.9)* | 41 (73.2) | 42 (46.2) |
| Enzalutamide | 0 (0.0) | 33 (58.9) | 33 (36.3) |
| Apalutamide | 1 (2.9)* | 2 (3.6) | 3 (3.3) |
| Darolutamide | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Safety population. Measurable disease based on the RECIST criteria was not required for patients with mCRPC; however, for patients with bone-only metastatic disease, this must be evaluable using PCWG3 criteria.
*Two patients in the BCR cohorts (patient 057 in Cohort 1B-BCR and patient 091 in Cohort 5B-BCR) received anti-androgen hormone suppressing medication within 2–4 years prior to study entry.
BCR, biochemical recurrence; ECOG PS, Eastern Cooperative Oncology Group performance status; mCRPC, metastatic castration-resistant prostate cancer; PCWG3, Prostate Cancer Working Group 3; PSA, prostate-specific antigen; RECIST, the Response Evaluation Criteria in Solid Tumors.