Publications & Clinical Data

Incorporation of IsoPSA Into Clinical Practice in the Management of Elevated Prostate-Specific Antigen Based on Current Guidelines

Reviews in Urology - September 2024

ABSTRACT: 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.

Using IsoPSA With Prostate Imaging Reporting and Data System Score May Help Refine Biopsy Decision Making in Patients With Elevated PSA

Journal of Urology - March 2023

ABSTRACT: 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.

Poster Presentation: The natural progression of patients with an IsoPSA value and its predictive ability of clinically significant prostate cancer on biopsy

2023 ASCO Genitourinary Cancers Symposium - February 2023

ABSTRACT: In 18-month follow-up, 1.1% of patients with normal IsoPSA developed csPCa compared to 28.5% of patients with high IsoPSA. In the cohort of patients with high IsoPSA and initially negative biopsy, 3.2% eventually developed csPCa, however, having a significantly higher IsoPSA than those who remained negative. The odds of having csPCa were 7 times higher with IsoPSA>10.

IsoPSA Performance Characteristics are Unaffected by 5-Alpha Reductase Inhibitors or Alpha-Blockers: Results From the IsoPSA Validation Study

Journal of Urology - February 2023

ABSTRACT: 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.

Clinical validation of IsoPSA, a single parameter, structure-focused assay for improved detection of prostate cancer: A prospective, multicenter study

Urologic Oncology: Seminars and Original Investigations - September 2022

ABSTRACT: 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.

Elevated IsoPSA Selects for Clinically Significant Prostate Cancer Without a Preference for Any Particular Adverse Histopathologic or Radiographic Feature

Journal of Urology - June 6, 2022

ABSTRACT: 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.

IsoPSA® Reduces Provider Recommendations for Biopsy and Magnetic Resonance Imaging in Men with Total Prostate Specific Antigen ≥4 ng/ml: A Real-World Observational Clinical Utility Study

Urology Practice - March 1, 2022

ABSTRACT: 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.

Decision Analysis Model Comparing Cost of IsoPSA® vs Repeat Biopsy for Detection of Clinically Significant Prostate Cancer in Men with Previous Negative Findings on Biopsy

Urology Practice - January 1, 2021

ABSTRACT: The use of IsoPSA to select patients for repeat biopsy reduced the number of biopsies needed by 34% and generated significant cost savings.

Clinical Validation of IsoPSA®, a Single Parameter, Structure Based Assay for Improved Detection of High Grade Prostate Cancer

Journal of Urology - June 1, 2019

ABSTRACT: 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 Single-parameter, Structure-based IsoPSA® Assay Demonstrates Improved Diagnostic Accuracy for Detection of Any Prostate Cancer and High-grade Prostate Cancer Compared to a Concentration-based Assay of Total Prostate-specific Antigen: A Preliminary Report

European Urology - April 7, 2017

ABSTRACT: 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.