Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Adenocarcinoma of the Prostate

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Absence of invaded lymph node after extensive lymph node dissection<br>Absence of invaded lymph node after extensive lymph node dissection | |
| Presence of invaded lymph node after extensive lymph node dissection<br>Presence of invaded lymph node after extensive lymph node dissection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicted risk of lymph-node involvement vs Briganti 2017 | Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017 | immediately after the intervention/procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC | Comparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC | immediately after the intervention/procedure/surgery | 
| Biochemical recurrence free survival | Prediction of Biochemical recurrence free survival | immediately after the intervention/procedure/surgery | 
| Extra-prostatic disease | Prediction of Extra-prostatic disease | immediately after the intervention/procedure/surgery | 
| Seminal vesicle invasion | Prediction of Seminal vesicle invasion | immediately after the intervention/procedure/surgery | 
| Automatic segmentation of the index lesion | Comparison between a manual segmentation of the index lesion and an automatic segmentation | immediately after the intervention/procedure/surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Lymph node