ClinicalTrials.gg
CompletedNCT03421015CHRU-WCMCUpdated May 22, 2026

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

An observational study in Prostatic Neoplasms, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
84
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms

Keywords

  • localized prostate cancer
  • prostatectomy
  • biomarkers
  • metastatic recurrence
  • genomic
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 84 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 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
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients managed by radical prostatectomy for prostate cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • positive imaging

Exclusion criteria

Exclusion Criteria:

  • therapy
  • Follow up \< 6 years
  • Prognostic Grade Groups (PGG) I-II
  • Biochemical recurrence with negative imaging
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

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

Groups and cohorts

  • case group

    patients with biochemical recurrence and positive imaging (case group)

  • Control Group

    patients without biochemical recurrence (control group)

06

What researchers measure

Primary outcomes

  1. The genetic alteration frequencies of TMPRSS2-ERG gene fusion

    Time frame: Baseline

Secondary outcomes

  1. Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),

    Time frame: Baseline

  2. Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),

    Time frame: Baseline

  3. Frequency of point mutations modifying protein function (SPOP)

    Time frame: Baseline

07

Study locations

1 site
  • Hôpital Claude Huriez, CHRU
    Lille, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Jul 2020, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 5, 2018
StartActual
May 1, 2017
Primary completionActual
Jul 31, 2020
CompletionActual
Jul 31, 2020
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03421015
Collaborators
Weill Medical College of Cornell University, New York Presbyterian Hospital
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
May 1, 2017
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020
Last update
May 22, 2026

Study contacts

Arnauld Villers, MD,PhD
principal investigator · University Hospital, Lille

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 May 2026. You cannot join it, but the record below documents what was studied.

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