Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHRU de Brest, Brest, Brittany Region, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18yo
Patients underwent radical prostatectomy
High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score > 7)

Exclusion criteria

No available pre-operative MRI
No analyzable pre-operative MRI
proof of lymph-node involvement (cN1/2 or pN1/2)
post-operative PSA > 0.04ng/mL

Treatment and study plan

Primary outcomes

Prediction of biochemical failure

Time frame: From the date of surgery until data collection (up to 100 months)

Comparison of AUCs between each predictive model

Secondary outcomes

Prediction of survival without biochemical failure

Time frame: From the date of surgery until data collection (up to 100 months)

Survival analysis: comparison of Kaplan-Meier curves

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PREBOP

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 21, 2019
Registry last updated: Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed