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Biotech / Medical : DiagnoCure noninvasive prostate cancer PCA 3 test -- Ignore unavailable to you. Want to Upgrade?

To: gg cox who wrote (2)	1/25/2006 11:22:08 AM
From: gg cox	Read Replies (1) \| Respond to of 6

Nice chart.. Abstract - CLINICAL BACKGROUND. Prostate cancer is the most commonly diagnosed malignancy affecting the Western male population. This disease can be cured by radical surgery or radiotherapy if the tumor is localized within the prostate. However, if the cancer has spread locally or distantly, no curative treatment is available and these patients will suffer from a poor prognosis. Therefore, early diagnosis of the disease can increase the cure rate for prostate cancer. The value of the herefrom resulting screening programs is still under debate, and there is little doubt that despite the utility of PSA in screening for prostate cancer it has great limitations too. The threshold above which biopsies are indicated has decreased now to a serum PSA value of 3 ng/ml, resulting in a negative biopsy rate of 70-80%. This can readily be explained by the fact that PSA is not prostate cancer specific. A more specific diagnostic test to identify clinically significant prostate cancer is urgently needed. - PRELIMINARY CLINICAL RESULTS. One approach to improve diagnostic accuracy of prostate cancer and a reduction in the number of biopsies is to identify prostate cancer specific genes. We identified DD3/PCA3 as a prostate specific gene in 1999 and showed that it was strongly overexpressed in prostate cancer. Quantitative assessment of the level of overexpression revealed that the average level of overexpression was 66-fold, and even the presence of a minute amount of cancer cells in prostate biopsies (~5%) could be discriminated from non-malignant prostatic tissues. To test the clinical utility of DD3/PCA3 the expression levels were quantitatively determined in urinary sediments after thorough digital rectal examination (DRE). The reasoning for this is that the manipulation of the prostate would transport the cancer cells, invading the secretori acini, via the prostatic ductal system into the prostatic urethra. The first voided urine would then contain the cancer cells in a background of urothelial and prostate cells. To test this hypothesis a clinical pilot study was done, using urinary sediments after DRE of 86 consecutive patients that were coded and analyzed by the molecular DD3/PCA3 RT PCR assay. The results were confronted with the subsequent biopsy results. The initial trial revealed a specificity of 84% to detect prostate cancer with this molecular DD3/PCA3 urine analysis in urinary sediments compared to 20% for serum PSA. This finding was confirmed by an independent multi-center Canadian pilot in ~ 470 patients. - PLAN OF INVESTIGATION. Establish the clinical utility of DD3/PCA3 based molecular diagnosis of prostate cancer in a Dutch multi-center study. The sensitivity, specificity to detect PrCa will be determined. The prognostic value of the ratio DD3/PCA3/PSA will be investigated since DD3/PCA3 expression increases with grade and PSA expression decreases. The quantitative RT-PCR assays are established and validated in the central laboratory (NCMLS: experimental urology). The pre-analytical sample handling protocols are tested (RNA preservation) and validated in the pilot study. - EXPECTED RESULTS. The quantitative RT-PCR assay for DD3/PCA3 , bears great promise as molecular urine analytical tool. It has great potential in reducing the number of unnecessary biopsies and a decrease in morbidity associated with this intervention is expected. The study will furthermore show the potential of the test to detect clinically significant prostate cancer. Thus, this multi-center study using validated DD3/PCA3 assays can provide the first basis for the utility of molecular diagnostics in clinical urological practice. Period 01/2004 - 12/2008 URL kwfkankerbestrijding.nl Related organisations Financier: Dutch Cancer Society Secretariat: Department of Urology (KUN) Related persons Project leader: Prof.dr. J.A. Schalken Project leader: Prof.dr. J.A. Witjes Classification A70000 : public health and health care D21400 : genetics D23120 : oncology D23220 : internal medicine onderzoekinformatie.nl