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Prostate Cancer Antigen 3 (PCA-3) Gene Project

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ClinicalTrials.gov Identifier: NCT01177436
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Prostate Cancer Benign Prostatic Hypertrophy Biological: Taking 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PCA-3 Gene Project
Study Start Date : September 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign). [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01177436


Locations
France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Cyrille BASTIDE Assistance Publique - Hôpitaux de Marseille
More Information

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01177436     History of Changes
Other Study ID Numbers: 2009-11
2009-A00567-50
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:
prostate cancer
benign prostatic hypertrophy

Additional relevant MeSH terms:
Prostatic Neoplasms
Hypertrophy
Prostatic Hyperplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathological Conditions, Anatomical