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Prostate Cancer

Prostate Cancer – DiaPat® PCa-PROteom Test

A positive PSA test (>4 ng/ml) often results in a prostate biopsy. Inflammations, bleeding or tumour spreading are frequent negative side effects of this procedure. The PCa-PROteom test enables identification of patients not harbouring prostate cancer with high probability that therefore should not undergo prostate biopsy. Analysing the urine proteome, PCa-PROteom test is a non-invasive, riskless and highly reliable diagnostic method. PSA is of limited value in the discrimination of benign and malignant prostate conditions and results in 70% false positive test results. The PCa-PROteom test detects those patients having a positive test result, i.e. tumour is indicated when in fact no cancer is present and consequently can help to reduce the number of biopsy interventions and the related risks.


Advantages of the DiaPat® PCa-PROteom Test

  • Painless (non-invasive urine sample)
  • Riskless sampling
  • Reliable (improved accuracy compared to PSA)


Risk factors:

  • Advanced age (>50)
  • Family history of cancer
  • Unbalanced diet or excess weight 
  • Smoking
  • Frequent exposure to cancer-causing chemicals (e.g. solvents, oil, petrol)

Since the advent of prostate specific antigen (PSA) screening, a significant number of men have had a PSA performed and this led to a considerable increase in the number of diagnosed cases. The inaccuracy of PSA screenings leads to estimated 800,000 unnecessary prostate biopsies per year in the United States.
In clinical trials, the DiaPat® PCa-PROteom Test test showed high accuracy in detection of prostate cancer with sensitivity of 86-90% and specificity of 59-69% in patients with PSA between 2 and 20 ng/ml, hence a negative predictive value of 91-93%. This represents a major advancement over serum PSA and determination of free PSA, with a positive predictive value of 25-30%. The non-invasive DiaPat® PCa-PROteom Test is a highly valuable complement of prostate cancer diagnostics for patients with suspicious PSA and/or digital-rectal examination.


DiaPat® PCa-PROteom Test

Urine sample
Accurate tumour detection in 9 out of 10 cases1

PSA - Test Biopsy
Bloodsample      Tissue samples are collected using 6- 12 hollow needles

≈ 70% of positive test results are false positive ((tumour is indicated when in fact no cancer is present)2

In ≈ 30% of patients with cancer needles miss the tumour (false negative biopsy)3

1 Dan Theodorescu et al., 2008, PROTEOMICS Clinical Applications
2 Schroeder et al., 2009, NEJM
3 Anastasiadis et al., 2006, Eur. Urol.

Compared to invasive diagnostic methods the advantages of the DiaPat® PCa-PROteom Test are obvious:

The PCa-PROteom test does not affect everyday life, because it does not require any pre-treatment or aftercare (e.g. taking antibiotics) as invasive biopsy methods. The collection of a simple urine sample represents a convenient and time-efficient method for both patients and physicians. In case of a negative PCa-PROteom test result, its high negative predictive value of >90% allows watchful waiting and the PCa-PROteom test can be repeated at any time for control purposes. A positive test result provides a clearer indication for a biopsy than PSA testing alone.


Schiffer E, Bick C, Grizelj B, Pietzker S, Schöfer W
Urinary proteome analysis for prostate cancer diagnosis: Cost-effective application in routine clinical practice in Germany
Int J Urol. 2012 Feb;19(2):118-25. doi: 10.1111/j.1442-2042.2011.02901.x. Epub 2011 Nov 22.

Siwy J, Vlahou A, Zimmerli LU, Zürbig P, Schiffer E
Clinical proteomics: Current techniques and potential applications in the elderly
Maturitas. 2011 Mar;68(3):233-44

Schiffer E
Urinary proteomics: ready for prime time in urological cancer diagnostics?
Personalized Medicine 2011, Jan;8 (1): 81-94

Schiffer E.
The 2nd annual oncology biomarkers conference.
Biomark Med. 2009 Apr;3(2):203-9.

Schiffer E, Mischak H, Zimmerli LU
Proteomics in gerontology - current applications and future aspects
Gerontology. 2009;55(2):123-37.

Theodorescu D, Schiffer E, Bauer HW, Douwes F, Eichhorn F, Polley R, Schmidt T, Schöfer W, Zurbig P, Good DM, Coon JJ, Mischak H
Discovery and validation of urinary biomarkers for prostate cancer
PROTEOMICS - Clinical Applications 2008, 2(4): 556-570

Schiffer E
Biomarkers for prostate cancer
World Journal of Urology 2007, 25(6): 557-562

Wittke S, Schiffer E, Bauer HW
Kapillarelektrophorese gekoppelte Massenspektrometrie zur Proteomanalyse: Eine innovative diagnostische Methode bei Prostata- und Blasenkrebs
Der Urologe 2007, 46(7): 733-739

Mischak H
Hochauflösende Proteomanalyse aus Urin in der nicht invasiven Diagnostik von Tumoren und chronischen Erkrankungen
prevention and anti aging 2006, 2(4): 426-435

Theodorescu D, Wittke S, Ross MM, Walden M, Conaway M, Just I, Mischak H, Frierson HF
Discovery and validation of new protein biomarkers for urothelial cancer: a prospective analysis
Lancet Oncol. 2006, 7(3): 230-240

Theodorescu D, Fliser D, Wittke S, Mischak H, Krebs R, Walden M, Ross M, Eltze E, Bettendorf O, Wulfing C, Semjonow A
Pilot study of capillary electrophoresis coupled to mass spectrometry as a tool to define potential prostate cancer biomarkers in urine
Electrophoresis. 2005, 26(14): 2797-2808

Kolch W, Mischak H, Pitt AR
The molecular make-up of a tumour: proteomics in cancer research
Clin Sci (Lond). 2005, 108(5): 369-383



The worldwide incidence of prostate cancer (PCa) ranks third among cancers in men. The occurrence of prostate cancer strongly depends on age. Prostate cancer develops most frequently in men over the age of 50. The mean age of onset is 72 years. Worldwide, several hundred thousand men die each year from prostate cancer. It is essential to detect prostate cancer at early stages, before cancer will spread to other organs, forming secondary tumours. At early stages, it is possible to cure prostate cancer in 80-90% of cases with only minimal or short-term treatment side effects. Following figures stress the importance of early diagnosis::


  Incidence Prevalence Mortality
Germany 44,383 162,895 12,158
North America 257,943 1,114,247 36,447
Europe (exept D) 180,844 580,475 70,908


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