Noninvasive Urine Test Predicts Grade Group Upgrading in Patients on Active Surveillance for Prostate Cancer: Prospective Multisite Validation and Comparison with MRI.
Abstract
We developed and externally validated a non-DRE urine test to inform whether biopsy is necessary in patients undergoing active surveillance (AS). Performance and clinical consequences of testing were directly compared with multiparametric magnetic resonance imaging (mpMRI).
Biomarker models (MyProstateScore 2.0-Active Surveillance [MPS2-AS]) were derived to predict upgrading to Grade Group (GG) ≥ 3 and GG ≥ 2 and externally validated across 11 practices. Urine was prospectively collected, and patients underwent ≥ 12-core systematic biopsy (SBx) plus targeted biopsy (TBx) of PI-RADS ≥ 3 lesions. Diagnostic performance and clinical consequences of urinary testing to determine the need for biopsy were compared with mpMRI.
The validation cohort included 330 patients with GG1 cancer scheduled for AS biopsy. Overall, 280 (85%) patients had prebiopsy mpMRI, of which 130 (46%) were PI-RADS 1 to 2, 42 (15%) were PI-RADS 3, and 108 (39%) were PI-RADS 4 to 5. On biopsy, 31 (9.4%) patients upgraded to GG ≥ 3 and 123 (37%) to GG ≥ 2. MPS2-AS provided higher AUC than mpMRI for upgrading to both GG ≥ 3 (0.82 vs 0.73) and GG ≥ 2 (0.74 vs 0.64). Clinically, prebiopsy MPS2-AS would have avoided 64% of unnecessary biopsies while failing to detect only 3.2% of GG ≥ 3 upgrades. By contrast, the use of PI-RADS ≥ 3 would have failed to detect 18% of GG ≥ 3 upgrades and avoided fewer unnecessary biopsies (50%). Performance of MPS2-AS was consistent across clinically pertinent subgroups (confirmatory and surveillance biopsy, Black and non-Black patients).
In a multisite AS population, urinary MPS2-AS provided highly accurate and actionable testing for GG ≥ 3 and GG ≥ 2 upgrading, meaningfully outperforming mpMRI on direct comparison. These findings suggest that noninvasive monitoring with MPS2-AS could reduce the need for scheduled biopsies and serial mpMRI.
EDRN PI Authors
Medline Author List
- Assani KD
- Bala V
- Barocas DA
- Britton CJ
- Cao J
- Chang SS
- Chevli K
- Chinnaiyan AM
- Cooperberg MR
- Gadzinski AJ
- Heaton S
- Joseph JV
- Kasraeian A
- Liss M
- Meyers JI
- Moore B
- Morgan TM
- Moses KA
- Oh Y
- Palapattu GS
- Patel P
- Penson DF
- Pierce J
- Rayford W
- Rings V
- Robinson HS
- Ross AE
- Salami SS
- Salari K
- Sanda MG
- Scarpato KR
- Sethi PS
- Siddiqui J
- Singhal U
- Tosoian JJ
- Wei JT
- Zhang Y
- Zheng Y