Prostatype Genomics: Filling Unmet Needs in Prostate Cancer Management

How to cite: Andriole DB. Prostatype Genomics: Filling Unmet Needs in Prostate Cancer Management. Grand Rounds in Urology.  November 2025. Accessed Apr 2026. https://grandroundsinurology.com/prostatype-genomics-filling-unmet-needs-in-prostate-cancer-management/

Summary

Gerald L. Andriole, Jr., MD, Chief Medical Officer, Prostatype Genomics, St. Louis, Missouri, outlines ongoing unmet needs in prostate cancer management despite the availability of several genomic classifiers. He explains that existing assays lack level 1 evidence to guide treatment decisions between active surveillance and definitive therapy” and  “and that many demonstrate inconsistency when evaluating different tumor foci within the same prostate. Dr. Andriole reviews data showing that commonly used genomic tests often overclassify risk and have limited reliability when biopsy sampling error is considered.

He emphasizes that clinical criteria alone are inadequate to identify which patients can safely undergo active surveillance. Citing long-term data from the PROTECT trial, he notes that even after 10 and 15 years, patients managed with observation had higher rates of metastatic progression and prostate cancer mortality compared to those receiving radical treatment, underscoring the need for more precise molecular tools.

Dr. Andriole describes the development and validation of the Prostatype Genomic Classifier, a quantitative pathologic complete response (PCR) assay based on three stem cell gene expression profiles derived from biopsy specimens rather than prostatectomy tissue. He explains that this biopsy-based design reduces the impact of tumor heterogeneity. Validation studies across multiple cohorts demonstrate strong predictive accuracy for prostate cancer-specific mortality, metastasis, and adverse pathology. Results also show high concordance between Prostatype risk classification and radical prostatectomy outcomes, even when biopsy Gleason scores differ.

Dr. Andriole asserts that the Prostatype test offers meaningful improvements in prognostic precision, validating its use in guiding the selection of active surveillance and tailoring surveillance intensity, particularly in cases where clinical or imaging findings are discordant.