R&D Areas | Oncology | Prostate Cancer

The worldwide incidence of prostate cancer ranks third among cancers in men. Since the advent of prostate specific antigen (PSA) screening, a significant number of men have had a PSA performed and this led to a significant increase in the number of diagnosed cases. However, PSA is of limited value in the discrimination of benign and malignant prostate conditions and these results in up to 800,000 unnecessary prostate biopsies per year in the United States.

Mosaiques applies urinary profiling using capillary electrophoresis online coupled to mass spectrometry (CE-MS) to the non-invasive diagnosis of prostate cancer. In a pilot study a panel of polypeptides that successfully discriminated initially voided urine from 26 patients with prostate cancer and 21 benign prostate hyperplasia (BPH) samples with sensitivity and specificity >90 % has been defined. Initially voided urine was hypothesized to contain sufficient prostatic secretions to allow diagnosis of prostate cancer. In a follow-up study the this concept was extended to the CE-MS based analysis of 552 urine samples. A dual pattern approach was developed assessing the existence of prostatic secretions with a first panel, the so called informative panel. This panel was developed by the comparison of 116 male 9 initial urine samples with 320 male midstream samples and was used to control the sufficiency of prostate secretion in a given urine sample. Subsequently, the informative samples were assessed for PC with a PC specific panel. This panel was established in the above mentioned set of 116 initial urine samples including samples of patients suffering from PC, BPH, or acute and chronic prostatitis. The dual panel approach, the informative panel in combination with the PC specific panel, was validated with an independent set of 96 urine samples. Eighty-one were found to be informative and were subsequently assessed for PC. This combined approach revealed correct classification of 88 % of the malign and 59 % of the benign samples. This work underlines the importance of standardizing urine sampling for biomarker discovery. Thus, the question whether to massage, the duration of the massage before collecting initial void or to collect a standard void, directly influences the ability to detect a given marker (panel) of prostate malignancy.