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Trial registered on ANZCTR


Registration number
ACTRN12623000713695
Ethics application status
Approved
Date submitted
25/05/2023
Date registered
5/07/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Artificial intelligence Steering Testosterone deprivation Treatments in prostate cancer External-beam radiotherapy (ASTuTE)
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
Secondary ID [1] 309745 0
None
Universal Trial Number (UTN)
Trial acronym
ASTuTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 330141 0
Condition category
Condition code
Cancer 327021 327021 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ArteraAI Prostate test will be conducted on an archival prostate tumour sample for each participant. There is no mandatory time frame within which the sample must be collected relative to study entry. For each tumour sample, an archival haematoxylin and eosin stained slide will be selected for testing. The slide will be digitally scanned and then uploaded to the ArteraAI server for testing.

The ArteraAI Prostate test has been developed using multi-modal AI (MMAI) and was trained and validated on 5 phase III randomised controlled trials. It uses clinical variables of combined Gleason score, Primary Gleason Score, Secondary Gleason Score, clinical T-stage, baseline PSA, and age. The AI utilizes two separate machine learning pipelines, one for pathological image analysis and the other for joint clinical and image data analysis. The MMAI score for distant metastases (DM) and Prostate Cancer Specific Mortality (PCSM) are performed in two independent learning systems with different MMAI scores outputted.

The ArteraAI test will be run automatically. The test report generated will be reviewed by a certified pathologist and approved prior to being released to the study site.

Participants will receive radiotherapy as per standard of care irrespective of timing of ArteraAI testing. If ADT is recommended by the treating investigator prior to the test being completed, it is recommended that treatment with ADT does not commence until the result is received in case of a change in recommendation. However, if it is deemed clinically necessary, the ADT may begin prior to this. Commencement of ADT prior to receiving a test result will be recorded in the Case Report Form.

Following 5 years after the ArteraAI Prostate test has been completed, a sub-set of 100 participants will be randomly selected for follow-up. Disease control at 5 years will be assessed in this random subset of participants by reviewing Prostate Specific Antigen (PSA) results that have been collected as part of standard of care. Participants are not required to undergo any additional procedures for this.
Intervention code [1] 326186 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334886 0
Characterize changes in shared treatment recommendations after ArteraAI testing regarding the use of short-course ADT in patients diagnosed with intermediate risk prostate cancer being treated with curative intent radiotherapy made by comparing pre-test and post-test treatment recommendations. Pre and Post Test recommendations will be collected in source documents that will be completed by the treating investigator.
Timepoint [1] 334886 0
Cumulative ArteraAI report data and documentation of recommendations will be reviewed at the conclusion of the study.
Secondary outcome [1] 422340 0
Comparison of pre and post-test costs including but not limited to testing and treatment related costs. Cost data will be sourced from an audit of clinic financial records.
Timepoint [1] 422340 0
To be calculated retrospectively following the end of study.
Secondary outcome [2] 422341 0
Biochemical disease control at 5 years defined by the Phoenix definition of nadir + 2ng/mL (blood Prostate Specific Antigen (PSA) measurement)
Timepoint [2] 422341 0
Following completion of 5 year follow-up for subset of 100 participants

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a trial of implementation that aims to collect real world data on the use of a MMAI driven biomarker digital histopathology test, ArteraAI for the use in intermediate risk prostate cancer.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
8/12/2023
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/06/2030
Actual
Sample size
Target
800
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 313932 0
Commercial sector/Industry
Name [1] 313932 0
GenesisCare
Country [1] 313932 0
Australia
Funding source category [2] 313934 0
Commercial sector/Industry
Name [2] 313934 0
ArteraAI
Country [2] 313934 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
GenesisCare
Building 7C & D,
Level 1, The Mill,
41-43 Bourke Road
Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 315801 0
None
Name [1] 315801 0
Address [1] 315801 0
Country [1] 315801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313077 0
St Vincent's Hospital Sydney HREC
Ethics committee address [1] 313077 0
Ethics committee country [1] 313077 0
Australia
Date submitted for ethics approval [1] 313077 0
31/07/2023
Approval date [1] 313077 0
08/11/2023
Ethics approval number [1] 313077 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126914 0
A/Prof Jarad Martin
Address 126914 0
GenesisCare
Lake Macquarie Private Hospital
36 Pacific Highway GATESHEAD NSW 2290
Country 126914 0
Australia
Phone 126914 0
+61249184500
Fax 126914 0
Email 126914 0
jarad.martin@genesiscare.com
Contact person for public queries
Name 126915 0
Rebecca Nathan
Address 126915 0
GenesisCare Building 7C & D, Level 1, The Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 126915 0
Australia
Phone 126915 0
+61429777325
Fax 126915 0
Email 126915 0
rebecca.nathan@genesiscare.com
Contact person for scientific queries
Name 126916 0
Rebecca Nathan
Address 126916 0
GenesisCare Building 7C & D, Level 1, The Mill, 41-43 Bourke Road Alexandria NSW 2015
Country 126916 0
Australia
Phone 126916 0
+61 429777325
Fax 126916 0
Email 126916 0
rebecca.nathan@genesiscare.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants are not providing consent to share IPD


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.