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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04063800

Acronym

PREBOP

Enrollment

195

Registered

2019-08-21

Start date

2018-06-26

Completion date

2018-08-28

Last updated

2019-09-12

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

Conditions

Prostatic Adenocarcinoma

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Prediction of biochemical failure	From the date of surgery until data collection (up to 100 months)	Comparison of AUCs between each predictive model

Secondary

Measure	Time frame	Description
Prediction of survival without biochemical failure	From the date of surgery until data collection (up to 100 months)	Survival analysis: comparison of Kaplan-Meier curves

Countries

France

Outcome results