Urine test shows utility in prostate biopsy decision-making in Black men

Data presented at the 2024 American Urological Association Annual Meeting in San Antonio, Texas underscore the utility of the non-invasive urine-based ExoDx Prostate Cancer test for risk assessment of high-grade prostate cancer in African American men considering diagnostic prostate biopsy.¹

Findings also showed that the ExoDx test had an impact on the decision to biopsy in the treatment arm.

Data from the study were obtained from the Prostate Biopsy Decision Impact Trial (NCT03235687), a level 1 evidence clinical trial that enrolled 1094 patients considered for initial prostate biopsy. All patients underwent ExoDx testing for the study, but patients in the treatment arm received results from the ExoDx test as part of their biopsy decision process and those in the control arm proceeded with standard of care (SOC). The current study, conducted at 2.5-year follow-up, included 833 patients with follow-up data from the initial 1094 patients to assess outcomes based on their pre-biopsy ExoDx score.

Overall, 21.7% (89/411) and 23% (97/422) of men in the ExoDx and SOC arms, respectively, were African American.

Significantly more high-grade prostate cancer was detected in the ExoDx cohort over the 2.5-year follow-up period compared with the SOC cohort. Specifically, among all African American men, 41.6% (37/89) received a diagnosis of high-grade prostate cancer in the ExoDx arm, compared with 29.9% (29/97) in the SOC arm. The authors noted that more high-grade prostate cancer was detected in the treatment arm due to more subjects in the high-risk group receiving a biopsy compared with those in the SOC arm.

To that end, findings also showed that the ExoDx test had an impact on the decision to biopsy in the treatment arm.

The authors concluded, “This data emphasizes the importance of utilizing the EPI test for risk assessment of high-risk prostate cancer in [African American] men. Using this test before a biopsy decision enables clinicians to enhance clinical outcomes and effectively manage patients' health.”

Additional data on ExoDx

Initial data from the 2.5-year follow-up of the real-world study were published in Prostate Cancer and Prostatic Diseases in September 2023.²

Overall, findings showed that men who received low ExoDx scores (below 15.6) significantly deferred their time to first biopsy and remained at very low pathologic risk by 2.5-year follow-up.

Specifically, the rate of biopsy for those with low-risk scores in the ExoDx arm was 44.6% compared with 79.0% among those with high-risk scores in the ExoDx arm (P < .001). In the SOC arm, the biopsy rates were identical regardless of ExoDx score (59.6% vs 58.8%; P = .99).

Data also showed that among those in the treatment arm, the average time from initial ExoDx test to first biopsy was 216 days for those with low-risk ExoDx scores vs 69 days among those with high-risk ExoDx scores (P < .001). Similarly, the average time to first biopsy from initial ExoDx testing was longer among those with low-risk scores in the treatment arm vs those with low-risk scores in the SOC arm (216 vs 80 days; P < .001).

At 2.5-year follow-up, 7.9% of patients with low-risk ExoDx scores from both arms had high-grade prostate cancer, compared with 26.8% of patients with high-risk ExoDx scores from both arms (P < .001). Overall, the treatment arm found 21.8% more high-grade prostate cancer than the SOC arm.

The real-world follow-up study remains ongoing to assess 5-year outcomes.

References

1. Tutrone RF, Kumar S, Ray C, et al. Utilization of ExoDx Prostate Test for prostate cancer risk stratification in the African American population. Presented at 2024 American Urological Association Annual Meeting. May 3-6, 2024, San Antonio, Texas. Abstract MP41-07

2. Tutrone R, Lowentritt B, Neuman B, et al. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):596-601. doi:10.1038/s41391-023-00675-1