Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

• Conditions: Adenocarcinoma of the Prostate

• Registration Number: NCT04909957
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Seminal vesicle invasion	immediately after the intervention/procedure/surgery	Prediction of Seminal vesicle invasion
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
Biochemical recurrence free survival	immediately after the intervention/procedure/surgery	Prediction of Biochemical recurrence free survival
Extra-prostatic disease	immediately after the intervention/procedure/surgery	Prediction of Extra-prostatic disease
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

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France