Genetic Analysis of Prostate Cancer to Identify Predictiv... | NCT03421015

Studies
Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution

NCT03421015

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

May 22, 2026Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Prostatic Neoplasms

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

ID	Type	Description	Link
2017-A01870-53	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

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

May 1, 2017Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Jan 29, 2018

First Submission Date that Met QC Criteria

Jan 29, 2018

First Posted Date

Feb 5, 2018Actual

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

May 21, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
Weill Medical College of Cornell University	OTHER
New York Presbyterian Hospital	OTHER

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

Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.

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

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case group		patients with biochemical recurrence and positive imaging (case group)
Control Group		patients without biochemical recurrence (control group)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The genetic alteration frequencies of TMPRSS2-ERG gene fusion		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),		Baseline
Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016.
Follow up > 6 years
Negative pre surgical extension assessment
Prognostic Grade Groups (OGG) III-IV-V
Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
Metastasis positive imaging

Exclusion Criteria:

Neoadjuvant therapy
Follow up < 6 years
Prognostic Grade Groups (PGG) I-II
Biochemical recurrence with metastasis negative imaging

Accepts Healthy Volunteers

Sex

All

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 managed by radical prostatectomy for prostate cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnauld Villers, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Claude Huriez, CHRU		Lille			France

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D012008	Recurrence

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