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

Prostatic Adenocarcinoma Clinical Trial

— PREBOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063800
• Other study ID #: PREBOP (29BRC18.0108)
• Status: Completed
• Start date: June 26, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Adenocarcinoma

Locations

Country	Name	City	State
France	CHRU de Brest	Brest	Bretagne
France	Centre Hospitalier de Cornouaille	Quimper	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

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