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Clinical Trials/ACTRN12623000713695
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

GenesisCare0 sites800 target enrollmentJuly 5, 2023

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.

Registry
who.int
Start Date
July 5, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

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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