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

Prostatic Neoplasms Clinical Trial

— CHRU-WCMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03421015
• Other study ID #: 2017_12
• Secondary ID: 2017-A01870-53
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: November 2019
• Source: University Hospital, Lille
• Contact: Arnauld Villers, MD,PhD
• Phone: 3 20 44 42 35
• Email: arnauld.villers[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHRU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	New York Presbyterian Hospital, Weill Medical College of Cornell University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The genetic alteration frequencies of TMPRSS2-ERG gene fusion		Baseline
Secondary	Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),		Baseline
Secondary	Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),		Baseline
Secondary	Frequency of point mutations modifying protein function (SPOP)		Baseline