NCT03421015
Unknown
Not Applicable
Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
University Hospital, Lille1 site in 1 country84 target enrollmentMay 1, 2017
ConditionsProstatic Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostatic Neoplasms
- Sponsor
- University Hospital, Lille
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- The genetic alteration frequencies of TMPRSS2-ERG gene fusion
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients managed by radical prostatectomy for prostate cancer between 2000 and
- •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
Outcomes
Primary Outcomes
The genetic alteration frequencies of TMPRSS2-ERG gene fusion
Time Frame: Baseline
Secondary Outcomes
- Frequency of point mutations modifying protein function (SPOP)(Baseline)
- Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),(Baseline)
- Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),(Baseline)
Study Sites (1)
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