ACTRN12623000713695
Recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- GenesisCare
- Enrollment
- 800
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •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
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.
Outcomes
Primary Outcomes
Not specified
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