Diagnosis of clinically significant prostate cancer
Research type
Research Study
Full title
The validity of urinary engrailed-2 for the diagnosis of clinically significant prostate cancer.
IRAS ID
170858
Contact name
Hardev Pandha
Contact email
Sponsor organisation
Royal Surrey County Hospital
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Prostate cancer PCa (PCa) is the most common male cancer and second most common cause of male cancer death. Currently most men are diagnosed with PCa as a result of a blood test called the PSA (Prostate Specific Antigen). Men, who present to their GPs with symptoms due to benign (non-cancerous) enlargement or simply requesting a PCa check, are offered a PSA test. However, the PSA test is not consistently accurate: the PSA level can be high and the man may not have PCa or likewise, to a lesser degree, the PSA can be normal and the man may harbour significant cancer.
There is therefore an urgent need to identify a test which is more accurate than PSA, a test that can identify men with significant PCa who need an MRI and prostate biopsy, but can also exclude men who don't have significant PCa, ensuring these men do not undergo unnecessary testing or anxiety.
We have completed a number of pilot studies and have shown that EN2 protein is expressed by cancer cells and actively secreted into the urine of men with PCa. We have shown urinary EN2 has high specificity and sensitivity as a diagnostic marker. A specific level of urinary EN2 was able to distinguish between PCa that was significant (needed immediate treatment) versus insignificant (could be monitored) on the basis of tumour volume.
The aim of this study is to evaluate urinary EN2 as a diagnostic biomarker in the setting of conventional urological practice. In addition, we will determine whether specific levels of EN2 in this setting correlate with radiological and pathological findings and aid in defining patients suitable for active surveillance versus those requiring immediate treatment.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/0218
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion