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Spots Global Cancer Trial Database for Prostate Cancer Antigen 3 (PCA-3) Gene Project

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Trial Identification

Brief Title: Prostate Cancer Antigen 3 (PCA-3) Gene Project

Official Title: PCA-3 Gene Project

Study ID: NCT01177436

Interventions

Taking of urines

Study Description

Brief Summary: Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA. Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene. The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

Detailed Description: Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA. The main drawback is the poor PSA specificity. Prostate cancer diagnosis is only histologic diagnosis (mainly by prostate biopsies). However, prostate needle biopsies have a poor rentability and are negative in 60 to 80%. Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene. This gene encodes for RNAm noncoding. So, RNA expression must be assayed by RT-PCR. The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department. PCA-3 assay will be made from urine specimens collected by vesical catheterism just before surgery. Moreover, the investigators will analyse expression of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2). The main objective is to improve the prostate cancer diagnosis specificity. Gene expression will be assayed by RT-PCR. Prostatic cells in urine specimens will be confirmed by assay of PSA gene expression. Normalization of data will be performed using 3 housekeeping genes expression (ß-actin, K-a-1 tubulin and Glyceraldehyde-3-phosphate). The originality of this clinical study compared to previous reports, consists to two elements. Firstly, all patients included in our study will be operated for a prostate cancer or a BPH. So, the risk to ignore a prostate cancer will be low unlike prostate biopsies made for a prostate cancer screening. Secondly, PCA-3 assay will be coupled with others prostatic specific markers.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Assistance Publique - Hôpitaux de Marseille, Marseille, , France

Contact Details

Name: Cyrille BASTIDE

Affiliation: Assistance Publique - Hôpitaux de Marseille

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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