PROLARIS® + AI PROSTATE CANCER PROGNOSTIC TEST

A new generation of integrated prostate prognostics

The Prolaris + AI Test, the FIRST and ONLY to unite clinical-pathological features, an independent molecular score, and independent AI-driven digital pathology. This combination helps guide IF a patient is safe for active surveillance (AS) and HOW intensive the AS protocol should be.1-6


PROLARIS® + AI PROSTATE CANCER PROGNOSTIC TEST

A new generation of integrated prostate prognostics

The Prolaris + AI Test, the FIRST and ONLY to unite clinical-pathological features, an independent molecular score, and independent AI-driven digital pathology. This combination helps guide IF a patient is safe for active surveillance (AS) and HOW intensive the AS protocol should be.1-6

Three integrated dimensions of risk. One actionable report.

For the reported AI metric, these core components predict likelihood higher Gleason score at next biopsy:6

Novel AI score used to predict a higher Gleason score

When considering active surveillance​

Select AS Safely​

An active surveillance threshold clinically validated in untreated patients, making it uniquely suited to guide safe active surveillance selection4,7-9

ACTIVE SURVEILLANCE

Regular monitoring and testing per guidelines recommendations

In the Prolaris Test validation study, NO patient below the AS threshold died of prostate cancer4

Plan Personalized AS Follow-up

A digital-pathology AI-based metric identifying the likelihood of a higher Gleason score at next biopsy to help personalize AS management.6

The AI metric will be included for any patient with a diagnostic Gleason score of 3+3 or 3+4, and a Prolaris score below the AS threshold.

Below average
Consider a less intensive AS approach:
  • Delay confirmatory biopsy
  • Less frequent biopsies
  • MRI-driven surveillance
  • Less frequent PSA testing
  • Less frequent DREs
Elevated
Consider a more intensive AS approach:
  • Early confirmatory biopsy
  • More frequent biopsies
  • Emphasis on MRI-targeted cores
  • Template or saturation biopsy
  • More frequent PSA testing
  • More frequent DREs

AI-powered digital pathology reveals image‑based features of aggressiveness not captured by routine clinical or pathological measures to independently predict the likelihood of higher Gleason score at next biopsy.6

After training in 998 untreated patients considered candidates for AS, the validation study (N=296) shows the AI metric was a significant independent predictor of upgrade (OR 1.60 per SD; p=0.0003).6

Without requiring additional tissue sample, the Prolaris + AI Test informs AS planning by providing a tool to help determine intensity.6

For patient report reference details, see the Test Description and References tab

Risk stratification comparison is provided on all patient reports

The multi-modal threshold was validated in two cohorts of patients receiving single-modal treatment (n=71811 and n=74112). Those above the threshold were at significantly greater risk of developing metastasis than patients below the threshold.

Risk of metastasis with single-modal therapy graph Risk of metastasis with single-modal therapy graph

The active surveillance threshold was validated in a cohort of conservatively managed patients (N=5854). Patients with scores above the threshold were at significantly different risk profiles compared to patients below the threshold. No prostate cancer-related deaths were observed in patients with scores at or below the threshold within 10 years of diagnosis in this cohort.

Individual patient results are shown relative to validated thresholds, supporting active surveillance and treatment selection decisions, and shown compared to other risk groups.

For patient report reference details, see the Test Description and References tab

When considering treatment​

A validated Multi-modal threshold, below which no benefit for treatment beyond surgery alone or radiation therapy alone was shown10,11

Single-Modal Therapy vs Multi-Modal Therapy graphic Single-Modal Therapy vs Multi-Modal Therapy graphic

When considering the addition of hormone therapy to radiation therapy, the estimated 10-year metastasis risk reduction when androgen deprivation therapy (ADT) is added to radiation therapy (RT) is reported12,13

The equation used to calculate Absolute Risk Reduction (ARR):

Graph describing calculation of Absolute Risk Reduction Graph describing calculation of Absolute Risk Reduction

Speak with our team about how the Prolaris + AI Test can support confident decisions

Request a consultation or receive more information about integrating the Prolaris + AI Test into your clinical workflow.

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Myriad Oncology™ provides clinical utility across the prostate cancer care continuum

This page includes AI generated images. Any similarity or resemblance to persons, living or dead, is purely coincidental.

References:

  1. Cuzick J, et al. Lancet Oncol. 2011;12(3):245-255.
  2. Cuzick J, et al. Br J Cancer. 2012;106(6):1095-1099.
  3. Cuzick J, et al. Br J Cancer. 2015;113(3):382-389.
  4. Lin DW, et al. Urol Oncol. 2018;36(6):310.e7-310.e13.
  5. Monda SM, et al. Poster session presented at: ASCO-GU; 2026 Feb; San Francisco, CA.
  6. Mabey B, et al. medRxiv. 2026; [Preprint] doi: https://doi.org/10.64898/2026.05.15.26353328.
  7. Kaul S, et al. Per Med. 2019 Nov;16(6):491-499.
  8. Lenz L, et al. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):427-434.
  9. Lenz, et al. Poster session presented at: ASCO-GU; 2024 Feb ; San Francisco, CA.
  10. Tward JD, et al. Clin Genitourin Cancer. 2021;19(4):296-304.e3.
  11. Tward JD, et al. Int J Radiat Oncol Biol Phys. 2022;113(1):66-76.
  12. Tward JD, et al. JCO Precis Oncol. 2024 May;8:e2300722.
  13. Kishan AU, et al. Lancet Oncol. 23:304- 316(2022)

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