Patient Demographics and Clinical Characteristics
| Known bone metastases at enrollment | ||
| Characteristic | Negative (n = 30) | Positive (n = 30) |
| Age (y) | ||
| Median | 65 | 64.5 |
| Range | 43–79 | 44–79 |
| Baseline PSA (ng/mL) | ||
| Median | 10.97 | 9.93 |
| Range | 0.01–190 | 0.1–593 |
| Gleason score | ||
| 4 | 1 (3%) | 0 |
| 6 | 4 (13%) | 3 (10%) |
| 7 | 7 (23%) | 10 (33%) |
| 8 | 8 (27%) | 5 (17%) |
| 9 | 9 (30%) | 11 (37%) |
| 10 | 0 | 1 (3%) |
| On treatment at NIH | ||
| Yes | 6 (20%) | 11 (37%) |
| No | 24 (80%) | 19 (63%) |
| Managed at NIH multidisciplinary clinic | ||
| Yes | 10 (33%) | 2 (7%) |
| No | 20 (66%) | 28 (93%) |
| Primary therapy | ||
| Radical prostatectomy | 14 (47%) | 13 (43%) |
| External-beam radiation | 8 (26%) | 7 (23%) |
| Brachytherapy | 2 (7%) | 0 |
| Castration status | ||
| Sensitive | 21 (70%) | 13 (43%) |
| Resistant | 9 (30%) | 17 (57%) |
| Therapy while on study | ||
| GnRH agonist/antagonist (leuprorelin/degarelix) | 28 | 26 |
| Antiandrogen (bicalutamide, nilutamide) | 14 | 13 |
| Ketoconazole | 1 | 4 |
| Enzalutamide | 0 | 1 |
| Abiraterone | 0 | 1 |
| Docetaxel, bevacizumab, lenalidomide, prednisone | 0 | 10 |
| Taxane | 0 | 2 |
| Bisphosphonate (zoledronic acid/dasatinib) | 3 | 6 |
| Sipuleucel-T | 0 | 3 |
| Vaccine study (TARP, Prostvac [Bavarian Nordic]) | 3 | 4 |
| TRC105 (TRACON Pharmaceuticals) | 1 | 1 |
| Radiation | 4 | 4 |
NIH = National Institutes of Health; GnRH = gonadotropin-releasing hormone; TARP, T-cell receptor γ alternate reading frame protein.
Total number of patients is 60. Data are number of patients, unless otherwise indicated.