Biopsy outcomes
cancer, HGPC
CANCER
The EPI arm received a single EPI test prior to the biopsy decision and the SOC arm received standard of care that could include other testing. At the end of the utility study, the EPI arm had found 30% more HGPC than the control arm. The low-risk patients that could defer a biopsy were not identified with the SOC parameters, as evaluated by the blinded EPI scores in the SOC arm (equal biopsy rate among high- and low-risk EPI in the blinded control arm). There was initially a high deferral rate of the biopsy in the SOC arm (60.7%), but it was equally distributed across EPI high- and low-risk patients and led to missing more HGPC in the SOC arm compared to the EPI arm. The additional biopsies performed over the next 2.5 years found additional cancer in both arms, but the EPI arm still found 21.8% more HGPC (≥GG2) than in the SOC arm (106 vs 87 HGPC). The biopsy deferral rate decreased in the SOC arm from 60.3% to 41%, and the deferral was again equally distributed across the high and low EPI scores (blinded to the urologist), indicating that EPI provides a unique value and SOC could not stratify the low- vs high-risk patients. In contrast, the biopsy deferral in the EPI arm 2.5 years later was still significantly higher in the low-risk EPI group vs high-risk group (55.4% vs 21%) (Supplemental Table 