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PRED-NCHIR: Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT04909957
Collaborator
(none)
400
Enrollment
1
Location
22.9
Anticipated Duration (Months)
17.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Nov 30, 2022
    Anticipated Study Completion Date :
    Nov 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Absence of invaded lymph node after extensive lymph node dissection

    Absence of invaded lymph node after extensive lymph node dissection
    Presence of invaded lymph node after extensive lymph node dissection

    Presence of invaded lymph node after extensive lymph node dissection

    Outcome Measures

    Primary Outcome Measures

    1. Predicted risk of lymph-node involvement vs Briganti 2017 [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 Outcome Measures

    1. Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC [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 2012, Briganti 2018, Briganti 2019 and MSKCC

    2. Biochemical recurrence free survival [immediately after the intervention/procedure/surgery]

      Prediction of Biochemical recurrence free survival

    3. Extra-prostatic disease [immediately after the intervention/procedure/surgery]

      Prediction of Extra-prostatic disease

    4. Seminal vesicle invasion [immediately after the intervention/procedure/surgery]

      Prediction of Seminal vesicle invasion

    5. Automatic segmentation of the index lesion [immediately after the intervention/procedure/surgery]

      Comparison between a manual segmentation of the index lesion and an automatic segmentation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Brest Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04909957
    Other Study ID Numbers:
    • 29BRC20.0290
    First Posted:
    Jun 2, 2021
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    MRI
    Lymph node
    Additional relevant MeSH terms:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jan 19, 2022