Prediction of the Risk of Biochemical Relapse After Radic... | NCT04063800

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

NCT04063800

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

195Actual

Phase

Not provided

Conditions

Prostatic Adenocarcinoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2018Actual

Primary Completion Date

Aug 28, 2018Actual

Completion Date

Aug 28, 2018Actual

First Submitted Date

Aug 19, 2019

First Submission Date that Met QC Criteria

Aug 20, 2019

First Posted Date

Aug 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2019

Last Update Posted Date

Sep 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

195Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male patients

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest	Brittany Region	29609	France
Centre Hospitalier de Cornouaille

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

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.

URL

Not provided