Prostate Cancer Antigen 3 (PCA-3) Gene Project

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01177436
First received: October 14, 2009
Last updated: August 6, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177436

Contacts
Contact: Cyrille BASTIDE cyrille.bastide@ap-hm.fr

Locations
France
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille, France
Contact: Cyrille BASTIDE       cyrille.bastide@ap-hm.fr   
Principal Investigator: Cyrille BASTIDE         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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 April 16, 2014