Table 1.
Baseline characteristics of patients in the intention-to-treat population
| 300 mg dose group (n=49) | 400 mg dose group (n=49) | ||
|---|---|---|---|
| Age at trial entry | 67·3 (61·2–72·1) | 67·6 (63·2–72·7) | |
| Years from initial diagnosis | 3·5 (2·4–6·4) | 5·2 (3·6–7·3) | |
| Years from diagnosis of castration-resistant prostate cancer | 2·4 (1·2–3·7) | 3·0 (1·8–4·0) | |
| Metastatic disease at diagnosis | |||
| Yes | 24 (49%) | 25 (51%) | |
| No | 24 (49%) | 21 (43%) | |
| Not available | 1 (2%) | 3 (6%) | |
| Gleason score at diagnosis | |||
| ≤7 | 4 (8%) | 15 (31%) | |
| ≥8 | 42 (86%) | 29 (59%) | |
| Not available | 3 (6%) | 5 (10%) | |
| Previous treatment for prostate cancer | |||
| Prostatectomy | 7 (14%) | 6 (12%) | |
| Radical radiotherapy | 22 (45%) | 21 (43%) | |
| Bisphosphonates | 2 (4%) | 2 (4%) | |
| Radium-223 | 6 (12%) | 8 (16%) | |
| Docetaxel | 49 (100%) | 49 (100%) | |
| Cabazitaxel | 15 (31%) | 22 (45%) | |
| Abiraterone acetate | 24 (49%) | 22 (45%) | |
| Enzalutamide | 27 (55%) | 29 (59%) | |
| Abiraterone acetate or enzalutamide or both | 43 (88%) | 45 (92%) | |
| Evidence of progression at trial entry | |||
| PSA only | 15 (31%) | 12 (24%) | |
| Radiographic progression (with or without PSA progression) | 34 (69%) | 37 (76%) | |
| Site of metastatic disease at trial entry* | |||
| Lung | 4 (8%) | 4 (8%) | |
| Lymph nodes | 34 (69%) | 32 (65%) | |
| Liver | 11 (22%) | 12 (24%) | |
| Bone | 41 (84%) | 41 (84%) | |
| PSA at trial entry, ng/mL | 151·5 (49·0–446·0) | 158·0 (45·5–472·0) | |
| CTC count per 7·5 mL blood at trial entry | |||
| <5 | 17 (35%) | 17 (35%) | |
| ≥5 | 31 (63%) | 32 (65%) | |
| Not available† | 1 (2%) | 0 | |
| RECIST 1·1 soft tissue disease | |||
| Bone lesions only | 5 (10%) | 5 (10%) | |
| Non-measurable disease (with or without bone lesions) | 5 (10%) | 8 (16%) | |
| Measurable disease (with or without bone lesions) | 39 (80%) | 36 (73%) | |
| DNA damage response gene aberration subgroup‡ | |||
| BRCA1/2 | 15 (31%) | 17 (35%) | |
| ATM | 10 (20%) | 11 (22%) | |
| CDK12 | 15 (31%) | 6 (12%) | |
| PALB2 | 3 (6%) | 4 (8%) | |
| Other | 10 (20%) | 11 (22%) | |
Data are median (IQR) or n (%). Percentages might not add up to 100% due to rounding. PSA=prostate-specific antigen. CTC=circulating tumour cell. RECIST=Response Evaluation Criteria in Solid Tumors.
More than one site could be reported.
Assessment of CTC count at screening not possible due to CTC kit shortage; the patient was allowed to be randomly assigned as he had RECIST 1·1 measurable disease; for randomisation CTC count was assumed to be <5 cells per 7·5 mL blood but the patient was unevaluable for CTC response.
Non-mutually exclusive subgroups: one patient in the 300 mg cohort had BRCA1/2, CDK12, and other mutations, and two patients in the 300 mg cohort had PALB2 and other mutations (in MSH2 and NBN, respectively).