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

Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03421015

Acronym

CHRU-WCMC

Enrollment

Registered

2018-02-05

Start date

2017-05-01

Completion date

2020-07-31

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

localized prostate cancer, prostatectomy, biomarkers, metastatic recurrence, genomic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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
Frequency of point mutations modifying protein function (SPOP)	Baseline

Countries

France

Contacts

PRINCIPAL_INVESTIGATORArnauld Villers, MD,PhD

University Hospital, Lille

Outcome results