Study to evaluate impact of ArteraAI on clinical decision-making for prostate cancer

Artera has announced the launch of the DIRECT-AI registry, which will assess the influence of the ArteraAI Prostate Test on treatment decisions for patients with localized prostate cancer.^1,2

The study will be conducted in 2 phases.

The ArteraAI Prostate test is a multimodal artificial intelligence (MMAI) biomarker test that “leverages a unique algorithm that assesses digital images from a patient’s biopsy and their clinical data.” The test has been validated using data from several phase 3 trials to predict therapy benefit and prognosticate long-term outcomes, making it the first of its kind for patients with localized prostate cancer.

"Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer,” said Tim Showalter, MD, MPH, chief medical officer at Artera, in a news release from the company.¹ “Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available.”

The study will be conducted in 2 phases. Phase 1 will assess the impact of results from the ArteraAI test on clinical decision-making. During this phase, the investigators will collect survey feedback from participating clinicians and patients on the impact of the test on treatment recommendations and selection.

Phase 2 of the study will focus on monitoring long-term outcomes at 2- and 5-year timepoints. Specifically, key outcome measures during this phase will include distant metastasis, prostate cancer-specific mortality (PCSM), overall survival (OS), adverse pathology at radical prostatectomy, and treatments received.

Patients are not eligible for enrollment if they have already begun receiving treatment for their localized prostate cancer.

Data collected from the registry are intended to guide future improvements to the test.

Data on ArteraAI

According to Artera, the ArteraAI test can identify 34% of patients who may benefit from short-term hormone therapy.³ In patients who were AI biomarker negative, the ArteraAI test had an HR of 0.92 (95% CI, 0.59 to 1.43; P = .71; n = 1046) in identifying patients who may not need short-term hormone therapy. In patients who were AI biomarker positive, the test demonstrated an HR of 0.34 (95% CI, 0.19 to 0.63; P < .001; n = 673) in identifying who may benefit from short-term hormone therapy.

The test also demonstrated superiority vs the National Comprehensive Cancer Network risk stratification models in prognosticating for distant metastasis, biochemical failure, PCSM, and OS. According to data published in Nature, the ArteraAI test demonstrated a 9.2% to 14.6% relative improvement over standard tools at a median follow-up of 11.4 years.⁴

Additional data on the ArteraAI test were also recently presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.⁵ Using data from the STAMPEDE trial (NCT00268476), the study found that the MMAI algorithm could accurately identify which patients with high-risk non-metastatic prostate cancer were most likely to benefit from the addition of abiraterone acetate (Zytiga) plus prednisone to standard of care androgen deprivation therapy. Data showed that continuous MMAI scores were statistically significantly associated with poorer PCSM, (HR, 1.65; 95% CI, 1.43 to 1.90; P < .001), metastasis-free survival (HR, 1.42; 95% CI, 1.29 to 1.56; P < .001), and distant metastasis (HR, 1.54; 95% CI, 1.36 to 1.74; P < .001) in these patients.

REFERENCES

1. Artera launches registry trial to measure real-world impact and outcomes of its prostate test. News release. Artera. Published online and accessed June 17, 2025. https://www.businesswire.com/news/home/20250617020135/en/Artera-Launches-Registry-Trial-to-Measure-Real-World-Impact-and-Outcomes-of-its-Prostate-Test

2. Direct AI Registry. Artera. Accessed June 17, 2025. https://info.artera.ai/directai

3. ArteraAI Prostate Test. Artera. Accessed June 17, 2025. https://artera.ai/arteraai-prostate-cancer-test

4. Esteva A, Feng J, van der Wal D, et al. Prostate cancer therapy personalization via multi-modal deep learning on randomized phase III clinical trials. NPJ Digit Med. 2022;5(1):71. doi:10.1038/s41746-022-00613-w

5. Parker C, Liu V, Mendes L, et al. Multimodal artificial intelligence (MMAI) model to identify benefit from 2nd-generation androgen receptor pathway inhibitors (ARPI) in high-risk non-metastatic prostate cancer patients from STAMPEDE. J Clin Oncol. 2025;43(suppl 16). doi:10.1200/JCO.2025.43.16_suppl.5001