FDA Approves a New AI Program to Evaluate Prostate Cancer Risk

All researchers must secretly hope that they will unlock a game-changing discovery. Such moments are true scientific triumphs. Though such scientists tend to be serious people, it’s not too much of a stretch to imagine them jumping for joy when their breakthrough proves to save lives.

In early July 2025, the FDA (Food and Drug Administration) granted a breakthrough device designation to an AI tool created by AI development company Artera. The new product, called ArteraAI Prostate, has been hailed as assisting “in risk-based decisions for localized prostate cancer by analyzing biopsy images to predict metastasis and mortality risks.”^[i] 

According to the company’s website, the tool was trained on data sets from tens of thousands of digital PCa tissue slides (pathology); the images were combined with patients’ clinical factors such as blood tests, Gleason grades, clinical stage, etc. Such integrated information is called multimodal artificial intelligence (MMAI). With cancer, speed in diagnosing and planning treatment is always important because the disease doesn’t stand still. MMAI operates with the speed of lightning, allowing clinicians to quickly and efficiently evaluate an individual patient’s 10-year probability of prostate cancer (PCa) spread, and the risk of dying from his cancer. This empowers risk-based treatment decisions.

ArteraAI didn’t just pop in out of the blue. For several years it has been clinically tested in a series of stepping stones to gain FDA approval. For example, last year we posted a blog describing a previous clinical study which validated that Artera’s MMAI could outperform the National Comprehensive Cancer Network’s risk group criteria.

A dramatic example of how ArteraAI Prostate can be put to practical use is determining if a patient with high-risk PCa that has not yet begun to spread may benefit from going on androgen deprivation therapy (ADT) plus a drug called Zytiga to keep the disease from spreading for longer periods of time. In order to find out how well ArteraAI Prostate could perform, its developers applied it to data from a very important published trial called STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy). This trial involved 12,000 PCa patients on various ADT combinations for their non-localized high-risk PCa. By statistical analysis, the developers found that their tool was highly accurate for predicting the risk of metastasis-free survival, distant spread, and PCa-specific mortality. In doing so, it illuminated the accuracy of ArteraAI Prostate to match each patient with the combination therapy that would be most effective, including those most likely to benefit from the addition of Zytiga to standard ADT.^[ii] 

As several of our previous blogs have pointed out the advantages of AI tools for busy radiologists who interpret prostate MRI scans, ArteraAI Prostate is a tool that holds advantages for pathologists—that is, specialists who analyze prostate biopsy slides. These professionals spend long hours peering through microscopes at cells, with countless cancer patients’ lives depending on their diagnostic skills. It’s no wonder that the FDA recognized the value of ArteraAI Prostate to support the efficiency and accuracy of pathology labs. FDA approval now enables the commercial availability of this program, a huge benefit to PCa doctors and patients, allowing tailored treatment plans with greater likelihood of success.  

In many ways, being able to post this blog allows Dr. Sperling and our experienced staff members to figuratively “jump for joy.” It’s always a source of happiness to be able to share good news with our readers—and this is one of the best.

NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.

References

[i] Saylor B and Clarke H. “FDA grants breakthrough device designation for ArteraAI Prostate tool.” Urology Times, July 10, 2025. https://www.urologytimes.com/view/fda-grants-breakthrough-device-designation-for-arteraai-prostate-tool
[ii] Parker CTA, Mendes L, Liu VYT, Grist E et al. External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol. Lancet Digit Health. 2025 Jul;7(7):100885.