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The risk of developing csPCa was smaller in patients with initial low vs high IsoPSA Indices over the ensuing 30 months, which supports using IsoPSA to safely avoid follow-up testing.
Many ancillary tests are available today for patients with an elevated PSA level. Among them, IsoPSA is a promising novel blood-based assay that more accurately detects prostate cancer and high-grade prostate cancer than standard PSA testing. By improving the negative predictive value of PSA testing, IsoPSA can reduce the need for MRI and prostate biopsy for patients with elevated PSA levels. Streamlining the use of IsoPSA may spare patients unnecessary costs and procedures while better identifying patients for prostate biopsy with or without a prostate MRI.
The combination of PI-RADS with IsoPSA [Index] may help refine the biopsy decision-making process. In our cohort, a negative or equivocal MRI with a low IsoPSA may provide a low enough predicted probability to omit biopsy in such patients.
The performance of IsoPSA for detecting any prostate cancer and clinically actionable prostate cancer is unaffected by commonly used medications (5-ARI and α-blockers) for symptoms of benign prostatic hyperplasia.
IsoPSA is a novel structure-focused test that interrogates the prostate specific antigen isoform composition in blood. Routine use of IsoPSA could result in a substantial reduction of unnecessary biopsies and improve the risk-benefit ratio for prostate cancer early detection.
Single center, retrospective review of patients who had undergone IsoPSA testing, prostate biopsy and RP at our institution from 2019-2021. Elevated IsoPSA is a diagnostic tool that can detect clinically significant prostate [cancer] at the time of biopsy. In doing so, it does not select for any particular adverse prostate MRI or pathologic feature at RP.
In a real-world clinical setting, providers from diverse training backgrounds and practice settings readily adopted IsoPSA with substantial reductions in the rate of recommended prostate biopsies in patients with elevated PSA values (≥4 ng/ml). There was a high concordance between recommendation for or against prostate biopsy and the IsoPSA result.
The use of IsoPSA to select patients for repeat biopsy reduced the number of biopsies needed by 34% and generated significant cost savings.
Validation of the structure based IsoPSA assay demonstrated statistical concordance with previously reported results and verified its superior performance vs concentration based prostate specific antigen and the free-to-total prostate specific antigen ratio. The assay improvement in detecting high grade prostate cancer using multiparametric magnetic resonance imaging-ultrasound guided biopsy may help define a new diagnostic paradigm.
The structure-based IsoPSA assay outperformed concentration-based PSA measurement, and provided a net benefit against other protocols. Once validated, clinical use of IsoPSA could significantly reduce unnecessary biopsies while identifying patients needing treatment.