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

NCT04063800 | Completed

• 1 other identifier: PREBOP (29BRC18.0108)
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 2

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).

Conditions

Prostatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Prediction of biochemical failure

  Comparison of AUCs between each predictive model

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

Secondary Outcomes (1)

• Prediction of survival without biochemical failure

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU de Brest

Brest, Brittany Region, 29609, France

Location

Centre Hospitalier de Cornouaille

Quimper, Brittany Region, 29000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: June 26, 2018
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning one year and ending following the publication
• 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.

Locations

FR (2)