A Panel of TMPRSS2:ERG Fusion Transcript Markers for Urine-Based Prostate Cancer Detection with High Specificity and Sensitivity

作者：Nguyen Phuong Nam; Violette Philippe; Chan Sam; Tanguay Simon; Kassouf Wassim; Aprikian Armen; Chen Junjian Z^*

来源：European Urology, 2011, 59(3): 407-414.

DOI：10.1016/j.eururo.2010.11.026

• TMPRSS2:ERG fusion
• Prostate cancer
• Urine test
• ERG
• Cancer diagnosis

Background: The TMPRSS2:ERG fusion is both prevalent and unique to prostate cancer (PCa) and has great potential for noninvasive diagnosis of PCa in bodily fluids.
Objectives: To evaluate the specificity and sensitivity of the TMPRSS2: ERG fusion in urine from diverse clinical contexts and to explore potential clinical applications.
Design, setting, and participants: A total of 101 subjects were enrolled in 2008 from urologic oncology clinics to form three study groups: 44 PCa free, 46 confirmed PCa, and 11 negative prostate biopsies. The PCa-free group included females, healthy young men, and post-radical prostatectomy (RP) patients. The confirmed PCa group was composed of patients under active surveillance, scheduled for treatment, or with metastatic disease.
Measurements: Urine was collected after attentive digital rectal exam (DRE) and coded to blind group allocation for laboratory test. RNA from urine sediments was analyzed using a panel of four TMPRSS2: ERG fusion markers with quantitative polymerase chain reaction (qPCR).
Results and limitations: Our fusion markers demonstrated very high technical specificity and sensitivity for detecting a single fusion-positive cancer cell (VCaP) in the presence of at least 3000 cells in urine sediments. In clinical analysis, there were no fusion-positive samples in the PCa-free group (0 of 44 samples), while there were 16 of 46 (34.8%) fusion-positive samples in the confirmed PCa group. The fusion incidence varied significantly among the three PCa subgroups. The clinical sensitivity increased to 45.4% in cancer patients prior to treatments. The fusion markers were detected in 2 of 11 (18.2%) biopsy-negative patients, suggesting potentially false negative biopsies. This study is not prospective and is limited in sample sizes.
Conclusions: Our novel panel of TMPRSS2: ERG fusion markers provided a very specific and sensitive tool for urine-based detection of PCa. Theses markers can potentially be used to diagnose patients with PCa who have negative biopsies.

• 出版日期2011-3