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PCA-3 Gene Project

18 Years
Open (Enrolling)
Prostate Cancer, Benign Prostatic Hypertrophy

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Trial Information

PCA-3 Gene Project

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Marseille


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2009

Completion Date:

October 2011

Related Keywords:

  • Prostate Cancer
  • Benign Prostatic Hypertrophy
  • prostate cancer
  • benign prostatic hypertrophy
  • Prostatic Hyperplasia
  • Hypertrophy
  • Prostatic Neoplasms