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CompletedNCT04063800PREBOPUpdated Sep 12, 2019

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

An observational study in Prostatic Adenocarcinoma, sponsored by University Hospital, Brest. Completed at 2 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
195
Ages
18 Years and older
Sex
Male
01

Study 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).

02

Conditions studied

  • Prostatic Adenocarcinoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 195 is above the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
195 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prediction of biochemical failure

    Comparison of AUCs between each predictive model

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

Secondary outcomes

  1. Prediction of survival without biochemical failure

    Survival analysis: comparison of Kaplan-Meier curves

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

07

Study locations

2 sites
  • CHRU de Brest
    Brest, Bretagne 29609, France
  • Centre Hospitalier de Cornouaille
    Quimper, Bretagne 29000, France
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04063800
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Jun 26, 2018
Primary completion
Aug 28, 2018
Completion
Aug 28, 2018
Last update
Sep 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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