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RecruitingLast updated: 2 February 2026

ASTuTE: Evaluating a new AI test that analyses prostate cancer tumour samples to see whether it helps doctors make more informed treatment recommendationsShared Decision making Using Multimodal Artificial Intelligence (MMAI) with Digital Histopathology for Androgen Deprivation Therapy (ADT) use in men with intermediate risk prostate cancer managed with standard of care radiotherapy

Trial purpose

Medical clipboardDiagnostic

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

ASTuTE

Clinical summary

Summary

This study aims to assess how a new test (called ArteraAI) that uses artificial intelligence (AI) to analyse prostate tumour samples to predict patient outcomes and suitable treatment options impacts the treatment recommendations that doctors make for their patients with prostate cancer.

Who is it for?
You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with a localised intermediate risk prostate cancer (one or more tumours) and you are scheduled to undergo initial curative radiation therapy treatment for your cancer.

Study details
All participants who choose to enrol in this study will have a sample of their prostate cancer assessed using a new test, ArteraAI, that uses AI and a specialised computer algorithm to analyse the characteristics of their specific cancer. 

The ArteraAI test will use previously collected tumour samples so that participants will not need to provide further tissue for this study. Depending upon the results of the ArteraAI test, participants may have their cancer treatment plan changed to include or stop use of androgen deprivation therapy or ADT (testosterone blocking drugs). 

A subgroup of participants will also be followed up at 5 years after they have undergone the ArteraAI test to check their Prostate Specific Antigen (PSA) levels noted in their medical records. PSA is collected as part of normal care follow-up for prostate cancer, therefore participants won't need an additional blood test for this.

It is hoped this research will determine whether use of the ArteraAI test helps doctors to make more informed treatment recommendations for patients with prostate cancer. If the ArteraAI test is found to be useful and the costs associated are not prohibitive to publicly-funded medical care, use of the test may be expanded to a greater number of cancer treatment clinics to assist a greater number of patients with prostate cancer. 

Conditions

This trial is treating people with intermediate risk, localised prostate cancer who are planning to undergo radiation therapy

Eligibility

Inclusion

1. Adult males greater than 18years of age

2. Participants must have intermediate risk, localised adenocarcinoma of the prostate according to National Comprehensive Cancer Network (NCCN) risk stratification:
o Favourable intermediate risk:
• 1 intermediate risk factor (IRF)
• Grade Group 1 or 2 (Gleason Score less than 6 or Gleason Score 7 {3+4})
• Less than 50% biopsy cores positive
o Unfavourable intermediate risk
• 2 or 3 IRFs
• Grade Group 3 (Gleason Score 7 )
• Greater than or equal to 50% biopsy cores positive
o IRFs:
• Clinical stage cT2b-cT2c
• Grade Group 2 or 3 (Gleason Score 7 {3+4} or Gleason Score 7 {4+3})
• PSA 10-20ng/mL

3. Estimated life expectancy >10 years

4. Participants must be planned to undergo eligible for curative-intent radiotherapy for prostate cancer


5. Willing and able to provide written informed consent and must be willing to comply with all study procedures.

Exclusion

1. Participants with insufficient tissue and/or histopathology issues which may arise pertaining to the generation of an accurate ArteraAITM Prostate Test result. Only FFPE specimens can be used for testing, specimens fixed with alternative methods are not eligible.

2. Participants with histological or cytological evidence of neuroendocrine or small cell differentiation.

3. Participants without a histologically proven prostate adenocarcinoma that can be International Society of Urological Pathologists (ISUP) graded

4. Node positive or presence of distant metastases (cN1 or cM1)

5. Participants who have already commenced ADT.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

GenesisCare

Scientific Title

Shared Decision making Using Multimodal Artificial Intelligence (MMAI) with Digital Histopathology for Androgen Deprivation Therapy (ADT) use in men with intermediate risk prostate cancer managed with standard of care radiotherapy

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