None listed
Conditions
Brief summary
This study aims to assess how a new test (ArteraAI) that uses artificial intelligence 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 radiotherapy 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 artificial intelligence 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 ADT (testosterone blocking drugs). A subgroup of participants will also be followed up at five 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.
Interventions
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 validat
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.
Sponsors
GenesisCare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed