Artificial intelligence Steering Testosterone deprivation Treatments in prostate cancer External-beam radiotherapy (ASTuTE)
- Conditions
- Cancer - ProstateProstate Cancer
- Registration Number
- ACTRN12623000713695
- Lead Sponsor
- GenesisCare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 800
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:
oFavourable 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
oUnfavourable intermediate risk
•2 or 3 IRFs
•Grade Group 3 (Gleason Score 7 )
•Greater than or equal to 50% biopsy cores positive
oIRFs:
•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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. [ Cumulative ArteraAI report data and documentation of recommendations will be reviewed at the conclusion of the study.]
- Secondary Outcome Measures
Name Time Method 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. [ To be calculated retrospectively following the end of study.];Biochemical disease control at 5 years defined by the Phoenix definition of nadir + 2ng/mL (blood Prostate Specific Antigen (PSA) measurement)[ Following completion of 5 year follow-up for subset of 100 participants]