Direct AI Registry

Artera is conducting a study to evaluate how the ArteraAI Prostate Test influences treatment decision-making among patients with localized prostate cancer, and create a prospective registry to track cancer outcomes of patients who receive the test.

The study is comprised of two parts:

Patient & physician surveys assessing the impact of the test on treatment selection / recommendation

Patient & physician surveys assessing the impact of the test on treatment selection / recommendation
Long term health outcome collection at 2- and 5-years:
- Distant Metastasis (DM)
- Prostate Cancer-Specific Mortality (PCSM)
- Overall Survival (OS)
- Adverse Pathology (AP) at Radical Prostatectomy (RP)
- Treatments Received

What is the purpose of the study?

This research will help Artera understand how the test impacts cancer care and monitor its performance so that it can be improved for patients in the future.

Who is eligible to participate?

Any patient who is receiving a commercial ArteraAI Prostate Test and their ordering physician are eligible to participate if their clinic is an enrolling site. Patients may not be eligible for this study if patients do not have localized prostate cancer, or if patients have already begun or received treatment for their localized prostate cancer.

What will happen if I enroll in the study?

If you are a patient:
If your provider asks you to participate in the DIRECT-AI Registry, you will need to consent to completing a short 5-10 minute survey and/or allowing Artera to collect your long term health outcomes from your doctor. Your only responsibility will be to complete the survey, which will ask about your experience with the ArteraAI Prostate Test.

This study is non-interventional, and does not require any additional procedures or tests. There will be no difference in the care you receive than if you decide not to participate.

If you are a physician:
If your clinic participates in the DIRECT-AI Registry, you will have the opportunity to enroll all patients for whom you order an ArteraAI Prostate Test in the study. As part of the study, you will complete a brief, 5-minute survey before and after receiving the test report, assessing your recommended treatment plan for each enrolled patient. This data will help evaluate the impact of the ArteraAI Prostate Test on shared decision-making between you and your patients.

Your primary responsibility in the study is completing these surveys. At 2- and 5-year follow-ups, Artera will contact your clinic’s research staff to collect long-term health outcomes for each patient.

What is the study duration?

For participating patients, the study will last 5 years. Artera will collect personal health information at 4 different timepoints:

Upon enrollment (e.g., consent, demographics, etc)
Within 14 days of receiving the ArteraAI Prostate Test (patient survey)
Long term health outcomes at 2-year follow-up
Long term health outcomes at 5-year follow-up

My clinic is interested in participating - what are the next steps?

Please fill out the form below or contact direct-ai@artera.ai if you have questions or are interested in participating.

Aspot - Center

Direct AI Registry

The study is comprised of two parts:

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