Evidence-Based Prediction of Late Genitourinary Adverse Events with PROSTOX

PROSTOX tests are clinically validated genetic tests that identify patients at increased risk for late genitourinary (GU) adverse events after external beam radiation therapy by analyzing inherited microRNA-associated genetic variants (mirSNPs). These variants affect pathways involved in DNA damage repair, inflammation, and cellular stress responses that are key biological drivers of individual radiation tolerance.

PROSTOX Risk Stratification 2026 update (horizontal)

PROSTOX Risk Stratification 2026 update (vertical)

Based on internal data from patients in clinical trials and real-world clinical settings.

Testing of a population of patients with localized prostate cancer shows that 96% of patients can safely receive external beam radiation therapy without being at high risk for developing late GU AEs.

Proven Guidance

Supported by a growing body of peer-reviewed clinical evidence, PROSTOX tests provide an objective risk profile that independently predicts outcome over traditional clinical factors and supports personalized treatment choices.

PROSTOX Ultra

Predicts late GU AEs risk from SBRT in patients with localized prostate cancer.

PROSTOX Standard

Predicts late GU AEs risk from CFRT/MHFRT in patients with localized prostate cancer.

Clinical Evidence Highlights

96% of patients are low-average risk on at least one of the two PROSTOX assays and can therefore safely receive EBRT without being at high risk of developing late GU AEs.¹

In a pooled analysis of multiple trials, patients identified as HIGH RISK by PROSTOX Ultra have an ~81% probability of developing late GU AEs with SBRT, compared with 15% among those in the LOW-AVERAGE RISK group (pooled AUC: 0.754).¹

In an independent validation, patients identified as HIGH RISK by PROSTOX Standard have a 61% probability of developing late GU AEs with CFRT/MHFRT, compared with 10% among those in the LOW-AVERAGE RISK group (pooled AUC is 0.779).

High-risk patients have a significantly higher likelihood of developing late radiation AEs compared with low-average risk patients (Odds Ratio of ~36.2 for PROSTOX Ultra and Odds Ratio of ~13.2 for PROSTOX Standard).¹

Late GU AEs risk is predicted independently of clinical or dosimetric variables.^1,2

Test results have been shown to guide both physician and patient treatment decisions.¹

Evidence

Explore the research and learn how PROSTOX can impact your and your patients’ treatment selection.

2026 | Multi-Cohort Validation

Biomarkers for late genitourinary adverse events after radiotherapy for prostate cancer

Validation and clinical utility

Germline biomarkers predict late genitourinary AEs from prostate cancer radiotherapy in a fractionation-specific manner, suggesting that personalizing radiotherapy fractionation choice will optimize survivorship.

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2025 | Economic Evaluation

Economic evaluation of a novel microRNA-based assay to determine risk of late genitourinary radiation toxicity in patients with prostate cancer

Health economic analysis

PROSTOX Ultra shows significant health system cost savings and quality-of-life gains for prostate cancer patients undergoing radiation therapy.

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2025 | Clinical Validation

Validation and derivation of miRNA-based germline signatures predicting radiation toxicity in prostate cancer

Phase III, randomized clinical study

PROSTOX can accurately predict late Grade ≥ 2 GU toxicity after SBRT, regardless of treatment modality.

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2023 | POST-OP Clinical Validation

Application of a genetic signature of late GU toxicity in SCIMITAR, a Post-op SBRT trial

Phase II, dual-center, single-arm clinical study

PROSTOX identifies a higher risk for late grade ≥ 2 GU AEs following post-prostatectomy SBRT.

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2022 | Development Study

Germline variants disrupting microRNAs predict long-term genitourinary toxicity after prostate cancer radiation

Development Study

Germline mirSNP-based predictive models effectively forecast late-grade ≥ 2 GU AEs following CFRT or SBRT.

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PROSTOX

Overview

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References:

Kishan A, McGreevy K, Telesca D, et al. Biomarkers for late genitourinary adverse events after radiotherapy for prostate cancer. Presented at ASTRO 2026 (submitted).
Kishan AU, McGreevy K, Valle L, et.al. Validation and derivation of microRNA-based germline signatures predicting radiation toxicity in prostate cancer. Clin Cancer Res. 2025 Jun 13;31(12):2530-2538. doi: 0.1158/1078-0432.CCR-24-3951.10.36469/001c.146844.