Objective
(1) Clinical study. Prostatic cancer is the second cause of death due to cancer in men. Progression of the early stage is relatively slow, providing a reasonable time wherein the disease can be cured. However, in spite of the availability of three updated tools, i.e. PSA (prostatic specific antigen) level measurements, digital rectal examination (DRE) and transrectal ultrasonography (TRUS), prostatic cancer is still diagnosed too late.
(2) Certified PSA Reference Material. PSA is one of the most promising tumor markers. Its merits (sensitivity, specificity and cost-effectiveness in diagnosing early stage prostate cancer) are now firmly established. PSA test kit producers and their European customers should have the possibility to validate their test systems with an EU-PSA standard.
(1) Clinical study. Establish reliable clinical and analytical criteria for early diagnosis and prevention of the disease (analytical behaviour of the various available PSA measurement methodologies, and reliable and realistic screening cut-off limit for this marker).
(2) Certified PSA Reference Material. Produce a certified PSA reference material, for standardisation of commercial PSA test systems, allowing harmonisation of methods and results within the EU, in compliance with the Community Directive on In Vitro Diagnostics.
(1) Clinical study. So far 450 volunteers have been studied according to the work programme. Initial results lead to preliminary observations: based on a cut-off level of >3.0 ng/ml PSA, cancer detection rates are around 3%, with a reduction of necessary biopsies of 55%. Assay methods do not always correlate, especially in the critical area of 3.0-4.0 ng/ml. The usefulness of age referenced PSA values is not obvious. Information from free/total PSA ratios are not straightforward.
(2) Certified PSA Reference Material. A new, modified procedure has been developed and applied for the purification of PSA from seminal fluid. It has allowed to obtain a more complete set of PSA isoforms, with a better overall yield (20-35 %), with a purity of > 98 %. The PSA obtained has been thoroughly characterised, and 5000 ampoules of lyophilised material have been prepared. Stability studies and value assignment measurements are under way.
(1) A clinical study. On 700 individuals, compare at least 6 different PSA screening methodologies, establish a reliable "cut-off" value, and confirm results using TRUS guided biopsies where appropriate.
(2) Certified PSA Reference Material. Prepare PSA from human seminal plasma. After thorough characterisation and assessment of its purity, homogeneity and stability, certify the material for its PSA protein content by combined aminoacid analysis and photometry.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine oncology prostate cancer
- natural sciences biological sciences biochemistry biomolecules proteins
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Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
77230 Dammartin-en-Goele
France
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