Cleveland Clinic study provides validation for the test, which combines AI and pathological data to predict outcomes in postoperative patients
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Prostate cancer
A new study supports the use of the ArteraAI prostate biomarker in men who have undergone radical prostatectomy. Researchers found the biomarker accurately predicted outcomes across diverse populations. The data was presented at the 2026 ASTRO annual meeting.
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In the large validation study, researchers found that the prognostic model scored higher risk populations such as Black and older men consistently with other patients. The findings support moving the model into clinical use, says study author Dr. Shalini Moningi, MD, a radiation oncologist at Cleveland Clinic Cancer Institute. “Our hope is that this study helps validate that this biomarker is legitimate and effective in all populations of patients.”
ArteraAI’s prostate test uses AI to analyze clinical and histopathological data to generate a unique biomarker predicting the aggressiveness of a patient’s cancer. The company’s intact prostate test has already been validated and is widely used in clinical settings. The new test expands its application to men who have undergone radical prostatectomy, using pathology slides from the patient’s own surgery combined with data from their clinical history.
Dr. Moningi wanted to study how the new test worked in Black men, who tend to have more aggressive disease and worse mortality from prostate cancer, as well as in older men, whose age can influence disease management and outcomes.
Prognostic models and biomarkers that are inconsistent across different ages and races exacerbate existing disparities in medicine, she notes. “It’s really important to make sure these tests are unbiased so that we can care for our patients based on their particular cancer.”
For the study, the researchers used data from the RTOG 0534 and 9601 clinical trials with a combined cohort of more than 1,800 men. They included pathology slides from men who had undergone radical prostatectomy to generate an Artera score, and compared those scores for Black and non-Black men, and men over and under age 70. They also compared the scores with the actual outcomes of the patients.
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They found that the test performed similarly across the different groups of patients, with no evidence of bias.
The biomarker could eventually be used in a clinical setting to help providers understand how aggressive a patient’s cancer is to inform treatment decisions. That could include offering or intensifying hormone therapy after surgery for a patient whose score predicts worse outcomes. But it could also mean knowing when hormone therapy could be safely avoided or intensity decreased, improving a patient’s quality of life.
“What bothers men the most is the systemic treatment side effects, so there’s a lot of emphasis on trying to figure out ways we can save them from that, or if we have to intensify it in order to help improve their outcomes,” Dr. Moningi says.
Next, more evidence is needed to support the use of the test in guiding patient management, and whether intensifying hormone therapy for patients with high scores leads to better outcomes and improved life expectancy.
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