Prostate Cancer Antigen 3 (PCA-3) Gene Project
キーワード
概要
説明
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.
日付
| 最終確認済み: | 07/31/2014 |
| 最初に提出された: | 10/13/2009 |
| 提出された推定登録数: | 08/05/2010 |
| 最初の投稿: | 08/08/2010 |
| 最終更新が送信されました: | 08/27/2014 |
| 最終更新日: | 08/28/2014 |
| 実際の研究開始日: | 08/31/2009 |
| 一次完了予定日: | 11/30/2011 |
| 研究完了予定日: | 11/30/2011 |
状態または病気
介入/治療
Biological: Patients treated for prostatic pathology
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Patients treated for prostatic pathology Patients treated for prostatic pathology (benign or malign)in the hospital department. | Biological: Patients treated for prostatic pathology 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. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Male |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. To evaluate the specificity and the sensibility of PCA-3 marker in patients treated for prostatic pathology (benign or malign). [18 months]
二次的な結果の測定
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]
