Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

NCT04909957 | Unknown

• 1 other identifier: 29BRC20.0290
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate

Keywords

MRI; Lymph node

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC

  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

• Seminal vesicle invasion

  immediately after the intervention/procedure/surgery

• Automatic segmentation of the index lesion

  immediately after the intervention/procedure/surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Unanalyzable pre-operative MRI

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU Brest

Brest, 29200, France

RECRUITING

Central Study Contacts

Ulrike Ulrike Schick

CONTACT

+33298223398; ulrike.schick@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: June 2, 2021
• Study Start: January 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three month and ending five years following the publication
• 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.

Locations

FR (1)