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

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).

Study Overview

• Status: Completed
• Conditions: Prostatic Adenocarcinoma

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Brest, Bretagne, France, 29609
      • CHRU de Brest
    • Quimper, Bretagne, France, 29000
      • Centre Hospitalier de Cornouaille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

- Patients with high-risk prostate cancers who underwent pre-operative prostate MRI followed by radical prostatectomy +/- lymphadenectomy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: PREBOP (29BRC18.0108)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning one year and ending following the publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No