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Prediction of Lymph Node Invasion for Prostate Adenocarcinoma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04909957
Acronym
PRED-NCHIR
Enrollment
400
Registered
2021-06-02
Start date
2021-01-01
Completion date
2022-11-30
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Prostate

Keywords

MRI, Lymph node

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Predicted risk of lymph-node involvement vs Briganti 2017immediately after the intervention/procedure/surgeryComparison between the predicted risk of lymph node involvement based on the new algorithm and the predicted risk with the Briganti 2017

Secondary

MeasureTime frameDescription
Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCCimmediately after the intervention/procedure/surgeryComparison 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
Biochemical recurrence free survivalimmediately after the intervention/procedure/surgeryPrediction of Biochemical recurrence free survival
Extra-prostatic diseaseimmediately after the intervention/procedure/surgeryPrediction of Extra-prostatic disease
Seminal vesicle invasionimmediately after the intervention/procedure/surgeryPrediction of Seminal vesicle invasion
Automatic segmentation of the index lesionimmediately after the intervention/procedure/surgeryComparison between a manual segmentation of the index lesion and an automatic segmentation

Countries

France

Contacts

Primary ContactUlrike Ulrike Schick
ulrike.schick@chu-brest.fr+33298223398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026