Prostate Cancer Antigen 3 (PCA-3) Gene Project | NCT01177436

Studies
Prostate Cancer Antigen 3 (PCA-3) Gene Project

NCT01177436

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 29, 2014Estimated

Enrollment

31Actual

Phase

Not Applicable

Conditions

Prostate Cancer
Benign Prostatic Hypertrophy

Interventions

Taking of urines

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00567-50

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Aug 6, 2010

First Posted Date

Aug 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2014

Last Update Posted Date

Aug 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated for prostatic pathology	Experimental	Patients treated for prostatic pathology (benign or malign)in the hospital department.	Biological: Taking of urines

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taking of urines	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign).		18 months

Secondary Outcomes

Measure	Description	Time Frame
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.		18 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cyrille BASTIDE	Assistance Publique - Hôpitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique - Hôpitaux de Marseille		Marseille			France

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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Browse Branches

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