Registry launches to assess real-world clinical utility of ArteraAI Prostate Test

A new prospective registry has begun enrolling patients with localized prostate cancer to evaluate how an artificial intelligence–based prostate cancer test affects treatment decisions and clinical outcomes in routine practice.¹

The DIRECT-AI registry will follow patients receiving the ArteraAI Prostate Test as part of standard care, with investigators assessing changes in treatment selection, clinician confidence, patient-clinician discussions, and longer-term outcomes. The first patient was enrolled at The Urology Place in San Antonio, Texas.

“As clinicians, we’re constantly evaluating whether new technologies truly change the way we care for patients or provide meaningful value beyond existing approaches,” said Naveen Kella, MD, founder and director of The Urology Place, in a news release from Artera.¹ “DIRECT-AI allows us to better understand how AI-powered insights are incorporated into routine clinical practice and how they support more informed conversations. We’re proud to contribute to generating this evidence, as it is an important step toward advancing more personalized prostate cancer care.”

Registry overview

DIRECT-AI is an observational, non-interventional registry. Patients receive the ArteraAI Prostate Test through routine clinical care, and participation does not require additional procedures. Participants will be followed for 1 year, with data collection occurring at 3 time points: at baseline (consent, demographics, etc), within 14 days of receiving the ArteraAI Prostate Test (physician survey), and at 1-year of follow-up to assess treatment received.²

According to the company, participating sites across the US will collect information about whether test results lead to changes in treatment selection and whether the results affect physician confidence and discussions with patients. The registry also may provide data for subsequent health economic and cost-effectiveness analyses by examining treatment patterns and health care resource utilization.

About the ArteraAI Prostate Test

The FDA granted de novo authorization to ArteraAI Prostate in August 2025 for non-metastatic prostate cancer.In June 2026, Artera announced clinical availability of the test to help inform treatment planning for patients with metastatic hormone-sensitive prostate cancer.³

The test works by analyzing digitized hematoxylin-eosin–stained prostate biopsy specimens together with clinical information to predict therapy benefit.

According to data from Artera, the ArteraAI test can identify the 34% of patients who may benefit from short-term hormone therapy.⁴ Among patients who were AI biomarker negative (n = 1046), there was no significant difference in the distant metastasis rate among patients who received radiation plus short-term ADT vs those who received radiation therapy alone (HR, 0.92; 95% CI, 0.59 to 1.43; P = .71), indicating that these patients may not benefit from the addition of hormone therapy. Conversely, among patients who were AI biomarker positive (n = 673), patients who received radiation plus short-term ADT demonstrated a significantly lower rate of distant metastasis (HR, 0.34; 95% CI, 0.19 to 0.63; P < .001), indicating that the test can identify patients who may benefit from short-term ADT.

The test can also be used to estimate long-term outcomes for biochemical failure, prostate cancer-specific survival, and overall survival.

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