After a biopsy diagnosis of prostate cancer, supported by an MRI and Ga 68PET/CT, if the disease is localized to the prostate, the initial decision is whether to treat the cancer with surgery or radiation therapy or defer to active surveillance. Treatment is usually the decision if the presentation is “high-risk” for recurrence (essentially Gleason Score >4+3, Gleason Grade 3 or higher with PSA greater than 10 ng/mL). Management of the intermediate-risk category is less clear cut since this grouping is very heterogeneous as to risk of progression, and even in the lowest risk groups (Gleason Score 3+3=6 and GG 1&2) there are some that carry a worrisome risk for progression. It is for these lower risk groups with localized disease that the Artera AI Prostate Test can provide a more accurate risk stratification to assist in management decisions. Two examples: whether to undergo active surveillance; or whether to accompany prostatectomy or radiation with hormone suppression (ADT).
The decision in all of these instances is best made with the accurate risk stratification available with Artera AI’s “Prostate Test.”
What is the Artera AI “Prostate Test?
It is explained on the web at “Artera AI Prostate Test” https://artera.ai/
The Prostate Test is an AI-powered tool that optimizes and personalizes treatment guidance. The risk assessment provided by this test is a prediction as to the likelihood of developing metastases in 10 years or dying from cancer in 10 years in relation to the chosen treatment. The test is an artificial intelligence-based assay combining a man’s clinical data and digital biopsy images. It produces an individualized biomarker — positive or negative — that becomes the basis of prediction of therapy benefit and long-term outcome. It is especially designed for men with the highly heterogeneous intermediate-risk cancer. For example, for men with intermediate- or high-risk disease who are biomarker positive, a period of ADT is recommended. For those men who are biomarker-negative ADT provides minimal benefit and is not recommended.
The “Prostate Test” is included in the National Comprehensive Cancer Network guidelines and provides a more accurate risk prediction than in the NCCN’s three risk stratification groups. The test is FDA approved and is covered by Medicare Part B. Medicare Advantage plans may require prior authorization. If not covered by insurance an applicant pays no more than $285. How to order the test is described in the Artera AI web site.
How Was the Test Developed?
The test emerged from the research by Donald Spratt et al (Eur Urol. 2024) who analyzed the results from 6 randomized clinical trials involving 1088 men with advanced stage PC, i.e., Gleason Score 8-10, PSA>20 ng/mL, with follow-up of 10.4 years. They combined information from histopathology slides and clinical data to “evaluate time to distant metastasis, prostate cancer-specific mortality and death with distant metastasis” and established an individual “biomarker” to distinguished which men were likely to benefit from various treatments. Their intention was that this data would “offer patients more personalized information for shared decision-making on treatment”. After further validation, this work led to the now commercially available Artera AI “Prostate Test.”
For What Treatment Decisions Can Artera AI’s Prostate Test Provide Management Guidance? (Discussed in detail on the Artera AI Web Site)
The test can both predict therapy benefit and prognosticate long-term outcomes of treatment for localized cancer. It addresses distant metastasis, likelihood of biochemical failure, prostate cancer-specific survival and overall survival.
Examples:
1) What is the benefit of adding 6-months or longer of ADT following radiation therapy?
2) What is the 10-year risk of metastasis following radical prostatectomy? What is the likelihood that adding ADT will be of benefit.
3) If considering active surveillance, considering the particular disease characteristics in question, what is the likelihood of adverse pathology if a prostatectomy were performed instead of AS. That is to say, is AS an appropriate choice?
4) For men with higher-risk for recurrence the test estimates the benefit of adding Zytiga/Prednisone to long-term ADT combined with radiotherapy.
BOTTOM LINE:
The Artera AI Prostate Test is an example of the combination of solid research combined with artificial intelligence to provide patients and physicians with a validated tool for guidance for treatment decisions.