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Completed

NCT Number: NCT01177436

Prostate Cancer Antigen 3 (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.

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Marseille

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 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.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

PCA-3 Gene Project

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 9, 2010
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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