Introduction: Our goal was to assess the impact of providing prostate cancer risk estimates to patients and urologists among biopsy-naïve men with mild PSA elevations.
Methods: This prospective intervention study was conducted in urology departments in Kaiser Permanente Northern California among biopsy-naïve men with mild PSA elevations (<10 ng/mL) between March 2021 and March 2023. The intervention was providing prostate cancer risk estimates for intermediate-/high-grade cancer (Grade Groups 2-5) and any cancer to patients and urologists using our previously validated risk calculator. Biopsy outcomes were compared to a historical comparison group biopsied between January 2016 and December 2019.
Results: Over 24 months, the risk calculator was used to estimate risk for 1962 men, of whom 1455 (74%) accepted the biopsy. The men who accepted the biopsy had higher predicted intermediate-/high-grade cancer risks (median 24%, interquartile range [IQR] 17%-31%, vs 20%, IQR 14%-29%; < .0001) and higher predicted risks for any cancer (median 48%, IQR 40%-56%, vs 45%, IQR 37%-53%, respectively; < .0001) than those who declined the biopsy. Compared to the historical group, use of the risk calculator resulted in a biopsy population enriched with intermediate-/high-grade cancer: 29% vs 25%; similar rates of low-grade cancer: 24% vs 24%; and fewer negative biopsies: 47% vs 51%, respectively; overall = .013.
Conclusions: In biopsy-naïve men with mild PSA elevations, use of this risk calculator resulted in a biopsy population that had more intermediate-/high-grade cancer and fewer negative biopsies compared to a historical group.
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