Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution
- Conditions
- Prostatic Neoplasms
- Registration Number
- NCT03421015
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The genetic alteration frequencies of TMPRSS2-ERG gene fusion Baseline
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hôpital Claude Huriez, CHRU
🇫🇷Lille, France