Development and commercialising of a diagnostic tool for early diagnosis of prostate cancer

Coordinator:    Dr. Alke Heitmann
Institution: QIAGEN Hamburg GmbH
Goal of this subproject is the development of a diagnostic tool which improves the early diagnosis of prostate cancer. Today for early diagnosis the tumour marker PSA (prostate specific antigen) and the conventional rectal examination are used predominantly. PSA is a protein which is formed in the prostate gland and is detectable in the blood. However, early diagnosis and thereby clinical management is limited by the low sensitivity and specificity of the existing diagnostic and prognostic tools. As an increased PSA value could have completely different, more harmless causes, e.g. a benign enlargement or an inflammation of the prostate gland. On the other hand decreased or PSA values in the normal range don’t exclude the presence of prostate cancer completely. If  the suspicion on prostate cancer consists a prostate tissue sample (biopsy) will be taken and these will be examined histopathologically for cancer cells. Depending on dimension and position of the tumour it is possible that the biopsy misses the tumour and only healthy tissue is taken. The cancer remains unidentified and could spread further unnoticed. In this cases the medical doctor has to decide if the patient or the PSA value should be monitored or if a rebiopsy is necessary. In this subproject a molecular-genetic based testsystem will be developed to show histologically invisible changes of the prostate tissue. This new testsystem builds an additional diagnostic tool to improve the basis for decision (monitoring/rebiopsy) of the doctor. Basis of this new diagnostic tool is a gene signature defined by the consortium. This gene signature consists of several genes (marker genes), which are differently expressed in tumour free-tissue of prostate cancer patients compared with prostate tissue from healthy patients. The parallel analysis of several marker genes suggests an increase of sensitivity and specificity as opposed to single markers. The prostate biopsy, which shows no tumour cells histopathological, will be analyzed by the new developed diagnostic test system so that histologically invisible changes in the prostate tissue will be detected. This additional procedure improves the detection of prostate cancer despite histopathological negative finding. The procedure for preparation of the biopsy and the validated simultaneous analysis of all relevant marker genes for prostate cancer offer ideal conditions for a reliable and early diagnosis of the prostate cancer.
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