ArteraAI Prostate Test Added to NCCN Guidelines for BCR After Prostatectomy

The National Comprehensive Cancer Network (NCCN) has added the ArteraAI Prostate Test (Post-RP), a multimodal artificial intelligence (MMAI) digital pathology–based tool, to its Clinical Practice Guidelines in Oncology for Prostate Cancer as an advanced prognostic tool for patients with biochemical recurrence (BCR) after radical prostatectomy (RP), according to a news release from the developer, Artera.¹ The test analyzes digitized images of surgical pathology specimens alongside clinical data to stratify patients by risk of disease progression and does not require additional tissue.

What do the NCCN guidelines say about the ArteraAI post-RP test?

Version 1.2027 of the guidelines lists the MMAI test in its table of advanced prognostic tools under the BCR post-RP setting, alongside the 22-gene genomic classifier, Decipher.² The panel's summary draws on a post hoc analysis of 533 patients from the phase 3 NRG/RTOG 0534 (NCT00567580) and 9601 (NCT00002874) trials who underwent secondary therapy after BCR following RP. In that analysis, patients with MMAI high-risk disease had a higher 10-year incidence of distant metastasis (DM) than those with MMAI low-risk disease (25% vs 8.8%). Adding hormone therapy to radiotherapy reduced the 10-year incidence of DM by an absolute 21% in the MMAI high-risk group vs 2.5% in the MMAI low-risk group.

Based on these findings, the panel stated that the benefit of adding androgen deprivation therapy (ADT) to radiotherapy for patients with recurrence after RP is likely to be smaller in those with MMAI low-risk disease than in those with MMAI high-risk disease. The guidelines also caution that, in the absence of prospective trials, these prognostic tools should be used carefully to influence treatment decisions, and the panel awaits future trials to confirm the initial results.

What data support the post-RP MMAI model?

The model was described by Todd M. Morgan, MD, of the University of Michigan Comprehensive Cancer Center, and colleagues in European Urology.³ Investigators trained the model to predict DM using histopathology image features and 5 clinical variables: pathologic grade group, pathologic T stage, prostate-specific antigen (PSA) level before salvage radiotherapy, age, and surgical margin status. The locked model was then validated in the same 533-patient cohort, all of whom received salvage radiotherapy with or without hormone therapy.

At a median follow-up of 9.3 years, the MMAI score was significantly associated with DM (subdistribution HR per standard deviation, 2.17; 95% CI, 1.65-2.85; P <.001) and remained independently prognostic after adjustment for clinical variables and treatment. The 10-year time-dependent area under the curve was 0.74 for the MMAI model vs 0.68 for a clinical nomogram. The investigators stated that external and prospective validation are ongoing.

The data were first presented at the 2024 American Urological Association Annual Meeting, and the test has since been externally validated in institutional cohorts from the University of California, San Francisco, and Mayo Clinic, according to Artera.

Why does risk stratification matter after radical prostatectomy?

An estimated 20% to 40% of patients who undergo RP eventually develop BCR, marked by a rising PSA level. For these patients, clinicians must decide whether to add hormone therapy to salvage radiotherapy, a choice that affects both treatment benefit and quality of life.

The NCCN guidelines recommend early salvage radiotherapy at a PSA level of 0.1 to 0.2 ng/mL for most patients who experience BCR after RP. However, the guidelines note that, unlike in localized disease, ADT in the post-RP setting has shown survival improvements in only a small subset of patients, which underscores the need for tools that identify who is most likely to benefit.

Where else does ArteraAI appear in the NCCN guidelines?

The ArteraAI Prostate Test was first included in the NCCN guidelines for localized prostate cancer in 2024, according to the developer. Version 1.2027 lists the MMAI test as an advanced prognostic tool for intermediate-risk and high- or very-high-risk disease, in addition to the new BCR post-RP setting. The guidelines note that the test received FDA authorization in July 2025.

References

1. ArteraAI Prostate Test (Post-RP) added to NCCN Guidelines. News release. Artera. November 11, 2026. Accessed November 11, 2026. https://tinyurl.com/4tf4x8vj
2. NCCN. Clinical Practice Guidelines in Oncology. Prostate cancer, version 1.2027. Accessed November 11, 2026. https://tinyurl.com/mths46pr
3. Morgan TM, Ren Y, Tang S, et al. Development and validation of a multimodal artificial intelligence–derived digital pathology–based biomarker predicting metastasis among patients with biochemical recurrence after radical prostatectomy in NRG/RTOG trials. Eur Urol. 2026;90(5):470-478. doi:10.1016/j.eururo.2025.12.007