PCA-3 Gene Project
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign).
Assistance Publique - Hôpitaux de Marseille
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)