Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2009-09-30
2011-12-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients treated for prostatic pathology
Patients treated for prostatic pathology (benign or malign)in the hospital department.
Taking of urines
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.
Interventions
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Taking of urines
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.
Eligibility Criteria
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Inclusion Criteria
* Patients not in state of emergency
Exclusion Criteria
* Patients with a vesical malign disease
* Patients in state of emergency
18 Years
MALE
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Cyrille BASTIDE
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Marseille
Locations
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Assistance Publique - Hôpitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2009-A00567-50
Identifier Type: -
Identifier Source: secondary_id
2009-11
Identifier Type: -
Identifier Source: org_study_id
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