TABLE 1.
Patient and Treatment Characteristics
| Characteristic | Control arm | PSMA PET/CT arm |
|---|---|---|
| All patients* | ||
| Median age (y) | 73.6 | 70.7 |
| Race | ||
| White | 17 (58.6%) | 16 (64.0%) |
| African American | 2 (6.9%) | 2 (8.0%) |
| Other | 10 (34.5%) | 7 (28.0%) |
| NCCN risk group | ||
| Unfavorable intermediate risk | 14 (48.3%) | 11 (44.0%) |
| High risk | 15 (51.7%) | 14 (56.0%) |
| Median initial PSA (ng/mL) | 8.4 (IQR, 4.9–20.5) | 10.7 (IQR, 6.4–12.9) |
| Gleason score | ||
| ≤7 | 18 (62.1%) | 13 (52.0%) |
| 8 | 5 (17.2%) | 4 (16.0%) |
| 9–10 | 6 (20.7%) | 8 (32.0%) |
| T stage by conventional imaging | ||
| T1–2 | 25 (86.2%) | 20 (80.0%) |
| T3–4 | 4 (13.8%) | 5 (20.0%) |
| N stage by conventional imaging | ||
| N0/Nx | 27 (93.1%) | 23 (92.0%) |
| N1 | 2 (6.9%) | 2 (8.0%) |
| Conventional imaging performed | ||
| CT | 1 (3.4%) | 1 (4.0%) |
| MRI | 8 (27.6%) | 7 (28.0%) |
| CT and MRI | 3 (10.3%) | 2 (8.0%) |
| Bone scan and CT | 1 (3.4%) | 1 (4.0%) |
| Bone scan and MRI | 0 (0%) | 3 (12.0%) |
| Bone scan, CT, and MRI | 11 (37.9%) | 10 (40.0%) |
| 18F-fluciclovine PET and MRI | 4 (13.8%) | 0 (0%) |
| 18F-fluciclovine PET, MRI, bone scan, and CT | 1 (3.4%) | 0 (0%) |
| 18F-fluciclovine PET, bone scan, and CT | 0 (0%) | 1 (4.0%) |
| Patients included in primary endpoint analysis† | ||
| Concurrent ADT | 21 (75.0%) | 18 (75%) |
| Pelvic lymph node irradiation | 7 (25.0%) | 8 (33.3%) |
| PSMA PET/CT miTNM stage | — | |
| miT2bN0M0 | 10 (41.7%) | |
| miT2cN0M0 | 4 (16.7%) | |
| miT3aN0M0 | 4 (16.7%) | |
| miT3bN0M0 | 2 (8.3%) | |
| miT3aN1M0 | 3 (12.5%) | |
| miT3bN1M1b | 1 (4.2%) |
*
All patients in the study (n = 29 patients in the control arm and 25 patients in the PSMA PET/CT arm).
†
Patients included in primary endpoint analysis (n = 28 patients in the control arm and 24 patients in the PSMA PET/CT arm).
NCCN = National Comprehensive Cancer Network; PSA = prostate-specific antigen; IQR = interquartile range; ADT = androgen deprivation therapy.
Data are number and percentage unless otherwise indicated.