Table. Baseline Patient Characteristics.
| Characteristic | Participants, No. (%)a | |
|---|---|---|
| Combined therapy (n = 43) | Hormone therapy only (n = 44) | |
| Age, median (IQR) [range], y | 67 (63-72) [49-84] | 67 (63-72) [51-81] |
| Race and ethnicity | ||
| Black | 4 (9) | 3 (7) |
| Hispanic | 4 (9) | 2 (5) |
| White | 33 (77) | 39 (89) |
| Otherb | 2 (5) | 0 |
| Enrollment site | ||
| MDACC | ||
| TMC campus | 32 (74) | 34 (77) |
| HAL campus | 10 (23) | 7 (16) |
| Network | 1 (2) | 3 (7) |
| Prior local treatment for prostate | ||
| None | 12 (28) | 12 (27) |
| Surgery | 26 (60) | 21 (48) |
| Radiation | 5 (12) | 8 (18) |
| Cryotherapy | 0 | 3 (7) |
| Castration sensitivity status | ||
| Sensitive | 39 (91) | 41 (93) |
| Resistant | 4 (9) | 3 (7) |
| Disease stage at enrollmentc | ||
| N1, M0 | 3 (7) | 3 (7) |
| N (any), M1a | 11 (26) | 11 (25) |
| N (any), M1b | 28 (65) | 29 (66) |
| N (any), M1c | 1 (2) | 1 (2) |
| Duration of hormone use before randomization, mo | ||
| 2-3 | 16 (37) | 18 (41) |
| 4-12 | 25 (58) | 22 (50) |
| >12 | 2 (5) | 4 (9) |
| Prior lines of systemic therapy, No. | ||
| 0 | 31 (72) | 31 (70) |
| 1 | 10 (23) | 12 (27) |
| 2 | 2 (5) | 1 (2) |
| PSA level at enrollment, ng/mL | ||
| ≤0.2 | 23 (53) | 27 (61) |
| >0.2 to <2.0 | 15 (35) | 14 (32) |
| ≥2.0 | 5 (12) | 3 (7) |
| Metastatic lesions, No. | ||
| 1 | 12 (28) | 21 (48) |
| 2 | 18 (42) | 13 (30) |
| 3 | 8 (19) | 4 (9) |
| 4-5 | 5 (12) | 6 (14) |
| Baseline imaging modality | ||
| CT CAP and bone scan | 33 (77) | 33 (75) |
| Fluciclovine F 18 PET/CT | 10 (23) | 11 (25) |
| Second-generation androgen receptor agent use | ||
| None | 24 (56) | 27 (61) |
| Abiraterone | 15 (35) | 13 (30) |
| Apalutamide | 3 (7) | 3 (7) |
| Enzalutamide | 1 (2) | 1 (2) |
Abbreviations: CT CAP, computed tomography of the chest, abdomen, and pelvis; HAL, all Houston-area locations; MDACC, The University of Texas MD Anderson Cancer Center; PET, positron emission tomography; PSA, prostate-specific antigen; TMC, Texas Medical Center.
SI conversion: To convert PSA level to micrograms per liter, multiply by 1.0.
a
Percentages may not add to 100% because of rounding.
b
Other includes Middle Eastern and not otherwise specified.
c
According to American Joint Committee on Cancer criteria.