Prostate Cancer Antigen 3 (PCA-3) Gene Project

NCT01177436 | Completed

• 2 other identifiers: 2009-112009-A00567-50
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Benign Prostatic Hypertrophy

Keywords

prostate cancer; benign prostatic hypertrophy

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (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.

  18 months

Study Arms (1)

Patients treated for prostatic pathology

EXPERIMENTAL

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

Biological: Taking of urines

Interventions

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.

Patients treated for prostatic pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients operated for a prostate cancer or a benign prostatic hypertrophy
• Patients not in state of emergency

You may not qualify if:

• Patients with an urinary infection proved bacteriologically
• Patients with a vesical malign disease
• Patients in state of emergency

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cyrille BASTIDE

  Assistance Publique - Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: August 9, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

FR (1)