Prostatic NeoplasmsCHRU-WCMCNCT03421015
Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution
An observational study of Prostatic Neoplasms, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2017to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients managed by radical prostatectomy for prostate cancer
Who may be able to join
- 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
Who cannot join
- Neoadjuvant therapy
- Follow up < 6 years
- Prognostic Grade Groups (PGG) I-II
- Biochemical recurrence with metastasis negative imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
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.
- Conditions
- Prostatic Neoplasms
- Keywords
- localized prostate cancer, prostatectomy, biomarkers, metastatic recurrence, genomic
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | patients with biochemical recurrence and positive imaging (case group) | |
| Control Group | patients without biochemical recurrence (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The genetic alteration frequencies of TMPRSS2-ERG gene fusion
Measured: Baseline
Secondary outcomes (3)
Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),
Measured: Baseline
Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),
Measured: Baseline
Frequency of point mutations modifying protein function (SPOP)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 May 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, New York Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Arnauld Villers, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421015
- Sponsor's protocol ID
- 2017_12
- Other IDs
- 2017-A01870-53
- Acronym
- CHRU-WCMC
- Status last verified
- May 2026
- First submitted
- 29 Jan 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
- ClinicalTrials.gov ID
- NCT03421015
- Acronym / sponsor ID
- CHRU-WCMC / 2017_12
- Conditions
- Prostatic Neoplasms
- Keywords
- localized prostate cancer, prostatectomy, biomarkers, metastatic recurrence, genomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, New York Presbyterian Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –patients with biochemical recurrence and positive imaging (case group) |
| Control Group | – | –patients without biochemical recurrence (control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients managed by radical prostatectomy for prostate cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Neoadjuvant therapy
- Follow up < 6 years
- Prognostic Grade Groups (PGG) I-II
- Biochemical recurrence with metastasis negative imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The genetic alteration frequencies of TMPRSS2-ERG gene fusion
Time frame: Baseline
3 secondary outcomes
Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),
Time frame: Baseline
Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),
Time frame: Baseline
Frequency of point mutations modifying protein function (SPOP)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnauld Villers, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The genetic alteration frequencies of TMPRSS2-ERG gene fusion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.