Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

Adenocarcinoma of the Prostate Clinical Trial

— PRED-NCHIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909957
• Other study ID #: 29BRC20.0290
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Brest
• Contact: Ulrike Ulrike Schick
• Phone: +33298223398
• Email: ulrike.schick[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Biochemical recurrence free survival	Prediction of Biochemical recurrence free survival	immediately after the intervention/procedure/surgery
Secondary	Extra-prostatic disease	Prediction of Extra-prostatic disease	immediately after the intervention/procedure/surgery
Secondary	Seminal vesicle invasion	Prediction of Seminal vesicle invasion	immediately after the intervention/procedure/surgery
Secondary	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