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Completed

NCT Number: NCT03421015

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

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.

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Key information

Conditions

Prostatic Neoplasms Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Claude Huriez, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • New York Presbyterian Hospital
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Acronym: CHRU-WCMC

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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