ArteraAI Pathology Test Launches for Personalizing Prostate Cancer Therapy

The ArteraAI Prostate Test was launched to provide a digital pathology solution that assists urologists and oncologists in personalizing therapy intensity for patients with metastatic hormone-sensitive prostate cancer (HSPC), according to a news release from the developer, Tempus AI.¹

Developed to calculate individual risk estimates of prostate cancer-specific mortality, the AI-powered platform marks the first externally developed prostate digital pathology algorithm embedded for clinical use within the Tempus diagnostics ecosystem. The company introduced this algorithmic solution to address a significant clinical gap in the therapeutic landscape for approximately 25,000 patients who are newly diagnosed with metastatic prostate cancer in the US each year, optimizing management directly at the point of care.

Main Data

Data from a poster presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which included validation cohorts from the phase 3 CHAARTED trial (NCT00309985), showed that the multimodal AI (MMAI) score for ArteraAI was prognostic for overall survival (OS; HR, 1.5; 95% Cl,1.33-1.73; P <.001) on univariable analysis for those with metastatic HSPC. Additionally, the estimated 5-year OS rates for high-, intermediate-, and low-risk groups were 39%, 58%, and 83%, respectively (log rank P <.001).

“From the start of our Tempus collaboration, our goal has been to deliver Artera’s AI-powered insights to [patients] in a streamlined, convenient, and impactful way," Amanda Lowe, chief commercial officer at Artera, stated in the release.¹ "We’re excited that the newest product line extension of our ArteraAI Prostate Test, designed specifically for [patients with] metastatic [HSPC], will now be easily accessible throughout the Tempus ecosystem."

Trial Details

Patients in the validation cohort of the CHAARTED trial were disaggregated into prognostic subgroups based on tumor volume and disease synchronicity. The clinical subgroups were then evaluated using multivariable analysis, which included MMAI risk group and treatment.

Patient Characteristics

Those selected in the validation cohort in the CHAARTED trial protocol were previously treated with androgen deprivation therapy alone (50%) or with docetaxel (50%). Patients in the study had a median age of 63.0 years (IQR, 57.0-69.0), were predominantly White (85%), and had high-volume synchronous disease (64%). The median PSA level at enrollment was 11.7 ng/mL (IQR, 1.8-67.5).

Main End Points

The primary end point of the validation study was prognostic ability of ArteraAI for OS in Cox proportional models.

Additional data from an external validation analysis of the phase 3 CHHiP trial (ISRCTN97182923) presented at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU) showed that the MMAI test was predictive of recurrence and distant metastases compared with standard tools.³ Specifically, the MMAI improved model discrimination in predicting recurrence per risk group vs CPG (P <.001) and NCCN (P <.001). Moreover, it was more predictive of distant metastases vs CPG (P <.001) and NCCN (P <.001).

In this trial, patients were recruited from 2002 to 2011 and had all received intensity-modulated radiation therapy (IMRT). Additionally, 97% had consistent androgen deprivation for 4 to 6 months.

Furthermore, another presentation given at ASCO GU showed that ArteraAI was reflective of diverse biologic drivers in metastatic HSPC, which included MYC signaling, cell proliferation, and epithelial–mesenchymal transition.⁴

The FDA granted ArteraAI breakthrough therapy designation as an AI precision medicine tool to assist clinicians with risk-based decisions for patients with localized prostate cancer in July 2025.⁵ Additionally, Artera’s laboratory is fully certified under the Clinical Laboratory Improvement Amendments and accredited by the College of American Pathologists.

References

1. Tempus launches ArteraAI prostate test for metastatic patients, marking the first prostate digital pathology algorithm in the tempus ecosystem available for clinical use. News release. Tempus AI, Inc. May 21, 2026. Accessed May 21, 2026. https://tinyurl.com/57seusd5
2. Markowski MC, Ren Y, Crouchen D, et al. Prognostic validation of a digital pathology-based multimodal artificial intelligence (MMAI) Biomarker in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the CHARTED trial (ECOG-ACRIN E3805). J Clin Oncol. 2024;42(suppl 16):5077. doi:10.1200/JCO.2024.42.16_suppl.5077
3. Stewart S, Limb E, Tovey H, et al. External validation of a digital pathology-based multimodal artificial intelligence (MMAI)-derived prognostic biomarker in the randomised phase III CHHiP trial. J Clin Oncol. 2026;44(suppl 7):308. doi:10.1200/JCO.2026.44.7_suppl.308
4. Shetty AC, Song Y, Mendes AA, et al. Opening the black box: biologic pathways underlying multimodal digital-pathology artificial intelligence in metastatic prostate cancer. 2026;44(suppl 7):232. doi:10.1200/JCO.2026.44.7_suppl.232
5. U.S. FDA grants Artera breakthrough device designation for AI-powered software transforming prostate cancer care. News release. Artera. July 9, 2025. Accessed May 21, 2026. https://tinyurl.com/yc8pbc9x