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Prostate Cancer Antigen 3 (PCA-3) Gene Project

Primary Purpose

Prostate Cancer, Benign Prostatic Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taking of urines
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, benign prostatic hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients treated for prostatic pathology

Arm Description

Patients treated for prostatic pathology (benign or malign)in the hospital department.

Outcomes

Primary Outcome Measures

To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign).

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.

Full Information

First Posted
October 14, 2009
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01177436
Brief Title
Prostate Cancer Antigen 3 (PCA-3) Gene Project
Official Title
PCA-3 Gene Project
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Benign Prostatic Hypertrophy
Keywords
prostate cancer, benign prostatic hypertrophy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated for prostatic pathology
Arm Type
Experimental
Arm Description
Patients treated for prostatic pathology (benign or malign)in the hospital department.
Intervention Type
Biological
Intervention Name(s)
Taking of urines
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrille BASTIDE
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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Prostate Cancer Antigen 3 (PCA-3) Gene Project

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