Assistance Publique - Hôpitaux de Marseille
Marseille, France
NCT Number: NCT01177436
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.
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Notify Me18 year and older
Male
Interventional
Not applicable
Marseille, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Urine specimens collected by vesical catheterism just before surgery. The dosage of PCA-3 and the analyse of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2) will be realized on the samples of urines.
Time frame: 18 months
Time frame: 18 months
Assistance Publique Hopitaux De Marseille
Other
PCA-3 Gene Project
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