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

GenesisCare0 个研究点目标入组 800 人开始时间: 2023年7月5日最近更新: 2024年4月8日

适应症

试验速览

暂无简介。

•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
•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.

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