Table 1.
FDA prostate cancer licensing trials 2006–2020.
| Trial name | NCT number (PMID ID of licensing study) | Drug | Prostate cancer disease subtype | No. participants | Race reported in licensing study | Race reported in the Trial report | No. Countries | Lead recruiting Country (% representation) | White/Caucasian | White Hawaiian/Pacific Islander | Black/African American | Asian | American Indian/Alaskan Native | Other/multiple | Unknown/missing | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CS21 | NCT00295750 (19035858) | Degarelix | Advanced | 610 | No | Yes | 12 | Unknown | 511 (83.8%) | Nil | 38 (6.2%) | 2 (0.3%) | 59 (9.7%) | Nil | Nil | |
| TROPIC | NCT00417079 (20888992) | Cabazitaxel | Metastatic castration-resistant | 755 | Yes | N/A | 26 | USA (26.8%) | 631 (83.6%) | Nil | 40 (5.3%) | 58 (7.6%) | Nil | 26 (3.5%) | Nil | |
| 20050103 | NCT00321620 (21353695) | Denosumab | Castration-resistant | 1901 | Limited breakdown | Yes | 39 | Unknown | 1639 (86.2%) | 2 (0.1%) | 73 (3.9%) | 48 (2.5%) | Nil | 139 (7.3%) | Nil | |
| COU-AA-301 | NCT00638690 (21612468) | Abiraterone | Metastatic castration resistant after chemotherapy | 1195 | No | Yes | 13 | USA (41.6%) | 1111 (93.0%) | Nil | 43 (3.6%) | 20 (1.6%) | 3 (0.3%) | 16 (1.3%) | 2 (0.2%) | |
| COU-AA-302 | NCT00887198 (23228172) | Abiraterone | Metastatic castration resistant no previous chemotherapy | 1088 | No | Yes | 11 | USA (43.4%) | 1030 (94.6%) | 2 (0.2%) | 28 (2.6%) | 13 (1.2%) | Nil | 12 (1.1%) | 3 (0.3%) | |
| AFFIRM | NCT00974311 (22894553) | Enzalutamide | Metastatic castration resistant after chemotherapy | 1199 | No | Yes | 15 | USA (24.0%) | 1111 (92.6%) | 1 (0.1%) | 47 (3.9%) | 13 (1.1%) | 2 (0.2%) | Nil | 25 (2.1%) | |
| ALSYMPCA | NCT00699751 (23863050) | Radium-223 | Metastatic castration-resistant (with bone metastasis) | 809 | Limited breakdown | No | 19 | UK (30.9%) | 759 (93.9%) | Nil | Nil | Nil | Nil | Nil | 50 (6.1%) | |
| PREVAIL | NCT01212991 (24881730) | Enzalutamide | Metastatic castration resistant—no previous chemotherapy | 1717 | Yes | N/A | 22 | USA (14.3%) | 1324 (77.1%) | 2 (0.1%) | 34 (2.0%) | 167 (9.7%) | 1 (0.1%) | Nil | 189 (11.0%) | |
| PROSELICA | NCT01308580 (28809610) | Cabazitaxel | Metastatic castration-resistant after chemotherapy | 1200 | Yes | N/A | 22 | France (10.6%) | 1054 (87.8%) | Nil | 25 (2.1%) | 81 (6.8%) | Nil | 40 (3.3%) | Nil | |
| LATITUDE | NCT01715285 (28578607) | Abiraterone | Metastatic castrate sensitive | 1199 | No | No | 34 | Russia and Romania (15.3% each) | Nil | Nil | Nil | Nil | Nil | Nil | 1199 (100%) | |
| SPARTAN | NCT01946204 (29420164) | Apalutamide | Non-metastatic castration-resistant | 1207 | Limited breakdown | Yes | 26 | USA (27.9%) | 800 (66.3%) | Nil | 68 (5.6%) | 140 (11.6%) | 4 (0.3%) | 1 (0.1%) | 194 (16.1%) | |
| PROSPER | NCT02003924 (29949494) | Enzalutamide | Non-Metastatic castration resistant | 1401 | No | Yes | 32 | USA (7.5%) | 991 (70.7%) | 5 (0.4%) | 31 (2.2%) | 230 (16.4%) | Nil | 28 (2%) | 116 (8.3%) | |
| ARAMIS | NCT02200614 (30763142) | Darolutamide | Non-metastatic castration resistant | 1509 | No | Yes | 36 | Unknown | 1194 (79.1%) | Nil | 52 (3.5%) | 193 (12.8%) | Nil | 15 (1%) | 55 (3.6%) | |
| TITAN | NCT02489318 (31150574) | Apalutamide | Metastatic castration sensitive | 1052 | Yes | N/A | 23 | Unknown | 719 (68.3%) | Nil | 19 (1.8%) | 229 (21.8%) | 19 (1.8%) | 47 (4.5%) | 19 (1.8%) | |
| ARCHES | NCT02677896 (31329516) | Enzalutamide | Metastatic castration sensitive | 1150 | Yes | N/A | 24 | Russia (12%) | 926 (80.5%) | Nil | 16 (1.4%) | 155 (13.5%) | Nil | 5 (0.4%) | 48 (4.2%) | |
| TRITON-2 | NCT02952534 (32086346) | Rucaparib | BRCA mutant associated metastatic castration-resistant | 76 | Limited breakdown | No | 12 | Unknown | 58a | Nil | 6a | Nil | Nil | Nil | 26a | |
| PROfound | NCT02987543 (32343890) | Olaparib | Homologous recombination repair gene-mutated metastatic castration-resistant | 387 | No | Yes | 20 | Unknown | 248 (64.1%) | Nil | 8 (2.1%) | 105 (27.1%) | Nil | 3 (0.8%) | 23 (5.9%) | |
| Total | N/A | N/A | N/A | 18,455b | N/A | N/A | N/A | N/A | 14,106 (76.3%) | 12 (0.1%) | 528 (2.9%) | 1454 (7.9%) | 88 (0.5%) | 332 (1.8%) | 1949 (10.5%) | |
aRace reported as non-mutually exclusive; therefore, percentages have been excluded (would exceed 100%).
bRace subtotals exceed grand total due to TRITON-2 being reported non-mutually exclusive, percentages have been adjusted correspondingly (for total = 18,469).