# ArteraAI Prostate

Source: https://onco.cc/drugs/artera-ai-prostate/  
OnCo record `artera-ai-prostate` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first AI tool cleared by the FDA to predict both prognosis and treatment benefit from a routine biopsy slide, in prostate cancer.

## Summary

ArteraAI Prostate is a multimodal artificial intelligence test that combines a deep-learning image encoder applied to routine H&E biopsy slides with clinical variables to predict the risk of distant metastasis and the benefit of short-term androgen deprivation therapy added to radiotherapy in localised prostate cancer. It was validated retrospectively on NRG/RTOG randomised trial cohorts, received FDA de novo authorisation in August 2025 as the first AI tool cleared to predict both prognosis and treatment benefit from a slide, and is listed in NCCN guidelines. Its practical use is helping men with intermediate-risk disease decide whether hormone therapy is worth its side effects. Prospective validation is the open question. For a newcomer: software that reads a biopsy slide to say how aggressive the cancer is and whether hormone therapy will help.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Modality: AI digital pathology prognostic/predictive test
- Mechanism: Deep-learning image encoder plus clinical data fusion.
- Approvals: US 2025: Localised prostate cancer risk stratification and ADT benefit prediction

## Sources

- Artera: ArteraAI tests: https://artera.ai/

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-risk/), [Localised prostate cancer, intermediate risk](https://onco.cc/cancers/prostate-intermediate-risk/), [Localised prostate cancer, very low and low risk](https://onco.cc/cancers/prostate-low-risk/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Active surveillance](https://onco.cc/technologies/active-surveillance/), [Digital pathology & AI](https://onco.cc/technologies/digital-pathology-ai/), [Pathology & radiology foundation models](https://onco.cc/technologies/pathology-foundation-model/)
- companies: [Artera](https://onco.cc/companies/artera/), [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- drugs: [Decipher Prostate](https://onco.cc/drugs/decipher-prostate/)
- pairings: [AI pathology → androgen deprivation duration](https://onco.cc/pairings/ai-pathology-to-adt/)
- people: [Amar U. Kishan](https://onco.cc/people/amar-kishan/), [Daniel E. Spratt](https://onco.cc/people/daniel-spratt/)
- bottlenecks: [AI that is built but not validated or deployed](https://onco.cc/bottlenecks/b-ai-validation/)
- roadmaps: [AI in oncology roadmap: pattern readers → foundation models → agents in the workflow](https://onco.cc/roadmaps/ai-oncology-roadmap/), [AI in the oncology clinic: from narrow cleared tools to multimodal decision support](https://onco.cc/roadmaps/ai-oncology-clinic/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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JSON: https://onco.cc/api/v1/entities/artera-ai-prostate.json