Prediction of Lymph Node Invasion for Prostate Adenocarcinoma (PRED-NCHIR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of the Prostate

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Ulrike Ulrike Schick; Phone Number: +33298223398; Email: ulrike.schick@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHRU Brest
    • Contact: Ulrike Schick, MD, PhD; Phone Number: +33298223398; Email: ulrike.schick@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

The population consists of patients operated on for an adenocarcinoma of the prostate by radical prostatectomy with extensive lymph node dissection and for whom pre-operative MRI is available and analyzable.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Absence of invaded lymph node after extensive lymph node dissection
Presence of invaded lymph node after extensive lymph node dissection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Lymph node
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 29BRC20.0290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three month and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No