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

NCT03421015 | Unknown

• 2 other identifiers: 2017_122017-A01870-53
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The genetic alteration frequencies of TMPRSS2-ERG gene fusion

  Baseline

Secondary Outcomes (3)

• 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

Study Arms (2)

case group

patients with biochemical recurrence and positive imaging (case group)

Control Group

patients without biochemical recurrence (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients managed by radical prostatectomy for prostate cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Weill Medical College of Cornell University: collaborator
• New York Presbyterian Hospital: collaborator

Study Sites (1)

Hôpital Claude Huriez, CHRU

Lille, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Arnauld Villers, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnauld Villers, MD,PhD

CONTACT

3 20 44 42 35; arnauld.villers@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: May 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

FR (1)