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​​​giving men a better chance of beating prostate cancer 

Biomarkers - Engrailed-2 (EN2) urine test for the diagnosis of prostate cancer

Work on the EN2 urine test to diagnose prostate cancer continues at the University of Surrey, Section of Oncology with a well established collaboration with Randox Ltd, Belfast.

We have ethical approval to commence a large clinical study (called PROCURE) which, if successful, we hope will allow us to move EN2 into the clinic for routine clinical use. However, at the moment, EN2 is a research concept and not a test that can be ordered or purchased. We hope to complete the clinical trial in winter 2018.  Details of the clinical trial can be found below and on the University website. The study is led by Mr Simon Bott, Consultant Urologist at Frimley Park Hospital, Camberley, Surrey.

The study is aimed at recruiting patients from the Surrey area. If you are not from this area, any enquiries to participate in the study should go through your general practitioner. Please do not contact the research team or Mr Bott directly.


Only men with a PSA between 4 and 20 ng/ml who do NOT have a prior history of prostate cancer will be eligible. Please note, neither University of Surrey or Randox Ltd are able to perform the EN2 test outside this clinical trial.

PROCURE study

Utility of urinary engrailed-2 for the diagnosis of clinically significant prostate cancer

Investigators: Mr Simon Bott, Consultant Urologist, Frimley Park HospitalProf Hardev Pandha, University of Surrey


Objective
The purpose of this project is to assess the clinical utility of the urinary biomarker engrailed-2 (EN2) in diagnosing clinically significant prostate cancer.  This study is anticipated to complete Winter 2018. The study will include patients from the Royal Surrey, Basingstoke, Frimley Park and Wexham  hospitals.

500 men with PSA between 4 and 20 ng/ml will be included having been referred by the GP. A blood and urine sample will be taken in the clinic and stored.

These men will then proceed though the normal patient pathway and have clinical examination, magnetic resonance scan of the pelvis and prostate biopsies as appropriate.  At the end of the study, the stored urine will be tested for the presence of EN2 protein. The researchers will ask:

Did the presence of EN2 correlate with the diagnosis of prostate cancer (as determined by the prostate biopsies)
In the prostate cancer patients, did the amount of EN2 correlate with the amount of disease present (in other words did larger (clinically significant) cancers make a lot of EN2, and smaller  (insignificant) cancers little EN2?)

The results of the study should be available in the autumn of 2016. We will keep everyone informed as the study proceeds through the Prostate Project Charity website.

Copyright ©​  The Prostate Project. All Rights Reserved. Tel 07724465883 info@prostate-project.org.uk  Charity No. 1078523

A simple 'dipstick' urine test  for prostate cancer.

Further reading and news reports

Urinary engrailed-2 (EN2) levels predict tumour volume in men undergoing radical prostatectomy for prostate cancer.
Pandha H, Sorensen KD, Orntoft TF, Langley S, Hoyer S, Borre M, Morgan R. BJU Int. 2012 Sep;110(6 Pt B):E287-92

Engrailed-2 (EN2): A Tumor Specific Urinary Biomarker for the Early Diagnosis of Prostate Cancer. 
Morgan R, Boxall A, Bhatt A, Bailey M, Hindley R, Langley S, Whitaker HC, Neal DE, Ismail M, Whitaker H, Annels N, Michael A, Pandha H. Clin Cancer Res. 2011 Mar 1;17(5):1090-8

BBC NEWS 1st MARCH 2011

SKY NEWS 1st MARCH 2011

WOMEN'S HOUR BBC RADIO 4 13th JUNE 2011



Publications


Annels NE, Simpson GR, Denyer M, McGrath SE, Falgari G, Killick E, Eeles R, Stebbing J, Pchejetski D, Cutress R, Murray N, Michael A, Pandha H. Spontaneous antibodies against Engrailed-2 (EN2) protein in patients with prostate cancer. Clin Exp Immunol. 2014 Mar 24

Pandha H, Sorensen KD, Orntoft TF, Langley S, Hoyer S, Borre M, Morgan R. Urinary engrailed-2 (EN2) levels predict tumour volume in men undergoing radical prostatectomy for prostate cancer. BJU Int. 2012 May 15.

McGrath SE, Michael A, Pandha H, Morgan R. Engrailed homeobox transcription factors as potential markers and targets in cancer. FEBS Lett. 2013 Feb 7.

Killick E, Morgan R, Launchbury F, Bancroft E, Page E, Castro E, Kote-Jarai Z, Aprikian A, Blanco I, Clowes V, Domchek S, Douglas F, Eccles D, Evans DG, Harris M, Kirk J, Lam J, Lindeman G, Mitchell G, Pachter N, Selkirk C, Tucker K, Zgajnar J, Eeles R, Pandha H. Role of Engrailed-2 (EN2) as a prostate cancer detection biomarker in genetically high risk men. Sci Rep. 2013;3:2059

Killick E, Morgan R, Launchbury F, Bancroft E, Page E, Castro E, Kote-Jarai Z, Aprikian A, Blanco I, Clowes V, Domchek S, Douglas F, Eccles D, Evans DG, Harris M, Kirk J, Lam J, Lindeman G, Mitchell G, Pachter N, Selkirk C, Tucker K, Zgajnar J, Eeles R, Pandha H. Role of Engrailed-2 (EN2) as a prostate cancer detection biomarker in genetically high risk men. Sci Rep. 2013;3:2059

McGrath SE, Michael A, Morgan R, Pandha H. EN2: a novel prostate cancer biomarker. Biomark Med. 2013 Dec;7(6):893-901

Morgan R, Boxall A, Bhatt A, Bailey M, Hindley R, Langley S, et al. Engrailed-2 (EN2): A Tumor Specific Urinary Biomarker for the Early Diagnosis of Prostate Cancer. Clin Cancer Res. 2011 Mar 1;17(5):1090-8


PSA is an important and useful test for prostate cancer. However, its use is limited by the fact that PSA levels also increase in non-cancerous conditions of the prostate. We have developed a more reliable way of detecting prostate and bladder cancers, by testing a small urine sample. We focused on the EN2 protein produced by these types of cancers, and which is secreted into urine. Importantly, the amount of EN2 in urine can also provide information about how large a tumour is. 


We have published our work in the journals Clinical Cancer Research and British Journal of urology, and we have received wide spread publicity in the media.  Clinical trials in both Europe and the United States have found that the EN2 biomarker test is twice as effective as the 30-year-old PSA blood test currently used to detect prostate cancer. Work is on going to improve the accuracy of the test and address its potential in diagnosis and surveillance.  It is hoped that a test could be made available in GP surgeries around the world. Hardev Pandha, Professor of Medical Oncology: " This new test could lead to faster detection that could save hundreds of lives, and also offers the potential for huge cost savings. "Unlike in previous tests that require invasive procedures to produce a trigger, our studies show that the EN2 test immediately shows up and that levels of the protein correlate strongly with how far the disease has spread. This may then help a doctor assess whether the disease may be safely and actively monitored, or whether it has spread more widely and requires treatment."