Prostate Cancer Antigen 3 (PCA-3) Gene Project
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer Benign Prostatic Hypertrophy |
Biological: Taking of urines |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PCA-3 Gene Project |
- To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To analyse expression of several other prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2)in the aim to improve the prostate cancer diagnosis specificity. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patients treated for prostatic pathology
Patients treated for prostatic pathology (benign or malign)in the hospital department.
|
Biological: 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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients operated for a prostate cancer or a benign prostatic hypertrophy
- Patients not in state of emergency
Exclusion Criteria:
- Patients with an urinary infection proved bacteriologically
- Patients with a vesical malign disease
- Patients in state of emergency
Contacts and Locations| Contact: Cyrille BASTIDE | cyrille.bastide@ap-hm.fr |
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Cyrille BASTIDE cyrille.bastide@ap-hm.fr | |
| Principal Investigator: Cyrille BASTIDE | |
| Principal Investigator: | Cyrille BASTIDE | Assistance Publique - Hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille, Direction de la Recherche |
| ClinicalTrials.gov Identifier: | NCT01177436 History of Changes |
| Other Study ID Numbers: | 2009-11, 2009-A00567-50 |
| Study First Received: | October 14, 2009 |
| Last Updated: | August 6, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
prostate cancer benign prostatic hypertrophy |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hypertrophy Prostatic Neoplasms Prostatic Diseases Genital Diseases, Male |
Pathological Conditions, Anatomical Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013