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Clinical Trials/NCT04909957
NCT04909957
Unknown
Not Applicable

Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma

University Hospital, Brest1 site in 1 country400 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenocarcinoma of the Prostate
Sponsor
University Hospital, Brest
Enrollment
400
Locations
1
Primary Endpoint
Predicted risk of lymph-node involvement vs Briganti 2017
Last Updated
4 years ago

Overview

Brief Summary

Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
November 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
  • Available pre-operative +/- PET choline

Exclusion Criteria

  • Unanalyzable pre-operative MRI

Outcomes

Primary Outcomes

Predicted risk of lymph-node involvement vs Briganti 2017

Time Frame: immediately after the intervention/procedure/surgery

Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017

Secondary Outcomes

  • Seminal vesicle invasion(immediately after the intervention/procedure/surgery)
  • Automatic segmentation of the index lesion(immediately after the intervention/procedure/surgery)
  • Biochemical recurrence free survival(immediately after the intervention/procedure/surgery)
  • Extra-prostatic disease(immediately after the intervention/procedure/surgery)
  • Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC(immediately after the intervention/procedure/surgery)

Study Sites (1)

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