Publications & Clinical Data
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.