Prostate Biopsies With Target Lesion on MRI | NCT04692207

Studies
Prostate Biopsies With Target Lesion on MRI

NCT04692207

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jan 5, 2021Actual

Enrollment

151Actual

Phase

Not provided

Conditions

Prostate Cancer

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

Dec 2020

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 1, 2017Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

Oct 30, 2020Actual

First Submitted Date

Dec 28, 2020

First Submission Date that Met QC Criteria

Dec 30, 2020

First Posted Date

Dec 31, 2020Actual

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

Dec 31, 2020

Last Update Posted Date

Jan 5, 2021Actual

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

Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).

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

151Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies	Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age > or = at 18 years old
Prostatic MRI performed at the Montpellier University Hospital
Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies

Exclusion criteria:

Pre-biopsy MRI performed outside of the Montpellier University Hospital
MRI with artefacts
Not performing 12 non-targeted prostate biopsies

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who had a prostate MRI between June 2017 and March 2020 for suspected cancer, followed by targeted and non-targeted prostate biopsies (12) at the Montpellier University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingrid Millet, PUPH	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided