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MiCheck\u00ae<\/span><\/sup> Prostate is an algorithm that combines the testing results of three serum immunoassays with the patient\u2019s clinical factors to calculate a MiCheck\u00ae<\/span><\/sup> Prostate Percentage Risk Score, providing an indication of the likelihood of the presence of clinically significant (i.e. <\/i>aggressive) prostate cancer. <\/span>The clinical factors that can be included in the algorithm are the patient\u2019s age, result from digital rectal examination (DRE) or a multiparametric MRI (mpMRI<\/b>)-derived prostate volume result.<\/span> <\/span><\/span><\/p>\n MiCheck\u00ae<\/span><\/sup> Prostate is for male subjects being considered by physicians for a prostate biopsy. It is intended to supplement and not replace the significance of other clinical factors or test results which collectively assist the clinical judgement and experience of the urologist in the decision about whether or not to proceed to prostate biopsy. Prostate biopsy is required for the diagnosis of cancer.<\/span><\/p>\n See Minomic Patent Estate<\/a><\/strong> and Peer Reviewed Publications<\/a><\/strong>.<\/p>\n [\/et_pb_text][et_pb_toggle title=”Read More” icon_color=”#75C044″ toggle_icon=”"||divi||400″ open_icon_color=”#75C044″ _builder_version=”4.21.0″ _module_preset=”default” title_text_color=”#93C178″ title_font=”|600|||||||” global_colors_info=”{}”]<\/p>\n PSA testing<\/b><\/span><\/b><\/span><\/p>\n PSA screening has significantly contributed to reducing prostate cancer mortality, with recent data demonstrating reductions in prostate cancer mortality of up to 35% following PSA screening [1]<\/span><\/sup>. However, an elevated PSA is not specific to prostate cancer, and it is frequently associated with benign conditions. <\/span><\/b><\/span><\/p>\n \u2022 Elevated PSA on its own is not a reliable indicator of prostate cancer, with only an estimated 18% of patients in the PSA 4-10ng\/ml range having a positive biopsy[2]<\/span><\/sup>.<\/span><\/p>\n \u2022 Elevated PSA can be caused by conditions other than prostate cancer, including prostatitis, enlargement of the prostate, bike riding and sexual activity, <\/span><\/p>\n \u2022 Elevated PSA cannot differentiate between patients without cancer, nor patients with non-clinically significant or clinically significant prostate cancer, and <\/span><\/p>\n \u2022 PSA results can vary according to the clinical analyser used, often leading to repeat testing.<\/span><\/b><\/span><\/p>\n mpMRI<\/b><\/span><\/p>\n MRI of the prostate is widely used in many countries, including Australia, following an elevated PSA. mpMRI enables visualisation of the prostate and grades the images using the Prostate Imaging Reporting and Data System (PI-RADS<\/b>) classifications developed by the International Prostate MRI Working Group. <\/span><\/b><\/span><\/p>\n The PI-RADS system categorises prostate lesions based on the likelihood of cancer according to a five-point scale, defined as the following:<\/span><\/span><\/p>\n PI-RADS 1<\/b>\u00a0\u2013 Clinically significant cancer is highly unlikely to be present.<\/span><\/p>\n PI-RADS 2<\/b>\u00a0\u2013 Clinically significant cancer is unlikely to be present.<\/span><\/p>\n PI-RADS 3<\/b>\u00a0\u2013 The presence of clinically significant cancer is equivocal.<\/span><\/p>\n PI-RADS 4<\/b>\u00a0\u2013 Clinically significant cancer is likely to be present.<\/span><\/p>\n PI-RADS 5<\/b>\u00a0\u2013 Clinically significant cancer is highly likely to be present.<\/span><\/span><\/p>\n Patients with PI-RADS scores of 4 and 5 will typically proceed to prostate biopsy, while those with scores of 1 and 2 will not. Biopsy decisions with patients with PI-RADS scores of 3 are particularly challenging, with clinically significant cancer rates of as low as 12%, compared to 60% for PI-RADS 4 and 83% PI-RADs 5[3]<\/span><\/sup>. Furthermore, there is no consensus on which PI-RADs 3 patients should proceed to biopsy. Despite current practice not recommending biopsy of patients with PI-RADS scores of 1 and 2, up to 18% of such patients can harbour clinically significant prostate cancer[4]<\/span><\/sup>. <\/span><\/span><\/p>\n A significant limitation of mpMRI is that the interpretation of the PI-RADS scores vary considerably between operators, with one study demonstrating the significant cancer yield across 9 operators ranged from 3% to 27% for PI-RADS 3, from 23% to 65% for PI-RADS 4, and from 40% to 80% for PI-RADS 5 lesions[5]<\/span><\/sup>. Therefore, the PI-RADs 1-3 group of patients requires the development of new complementary technologies to assist urologists in making a clinical determination of which patients would benefit from proceeding to biopsy.<\/span><\/span><\/p>\n The USANZ issued a position statement on MRI for prostate cancer in 2016. Its recommendations were as follows:<\/span><\/span><\/p>\n Although primarily under the jurisdiction of the RANZCR, USANZ supports the following general principles:<\/i><\/span><\/i><\/span><\/p>\n Prostate biopsy<\/b><\/span><\/span><\/p>\n Prostate biopsy is the definitive diagnostic tool for prostate cancer. <\/span><\/span><\/p>\n The biopsy pathology report includes information on the tumour grade and stage. Tumour grade relates to tumour aggressiveness and is reported using either the Gleason score or the Grade Group system, while tumour stage relates to whether the tumour is localised or whether it has spread throughout the body (summarised in the PCFA guidance booklet \u201cProstate cancer \u2013 a guide for newly diagnosed men[6]<\/span><\/sup>): <\/span><\/span><\/p>\n Prostate Cancer Grading<\/i><\/b><\/span><\/p>\n Gleason grade 1 and 2 patterns are very rarely used anymore. This means that the lowest pattern number for prostate cancer is pattern 3. There is often more than one pattern of cancer present in the biopsy. The two most common patterns of growth seen in the biopsy sample are each given a number from 1 to 5, and then these two numbers are added together to give the Gleason Score (e.g., 4 + 3 = 7). <\/i><\/span><\/i><\/span><\/p>\n If the first and second most common patterns in a biopsy are both pattern 3, then the Gleason Score would be 3 + 3 = 6. This is a very low-grade cancer. <\/i><\/span><\/i><\/span><\/p>\n If both first and second most common patterns are grade 5, the Gleason Score will be 5 + 5 = 10. These cancers are very high grade. Low grade cancers usually grow slowly and are unlikely to spread. Higher grade cancers are more aggressive, can grow more quickly and may spread to other parts of the body. <\/i><\/span><\/i><\/span><\/p>\n Gleason scores of 3+4 or higher are considered clinically significant, or aggressive. Gleason scores of 3+3 are considered indolent cancers that are unlikely to prove clinically significant.<\/i><\/b><\/span><\/i><\/span><\/p>\n The decision to proceed to prostate biopsy is made by the urologist with informed consent from the patient. The urologist will always make the decision based on their clinical judgement and experience. Factors that the urologist will consider when recommending a biopsy include the patient\u2019s:<\/span><\/span><\/p>\n There are several shortcomings in the current testing regimes, including:<\/span><\/span><\/p>\n PSA screening<\/b><\/span><\/p>\n mpMRI <\/b><\/span><\/p>\n Prostate biopsy<\/b><\/span><\/p>\nCurrent prostate cancer testing regimes<\/b><\/span><\/b><\/span><\/h4>\n
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Decision to proceed to prostate biopsy<\/b><\/span><\/h4>\n
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Shortcomings of current testing regimes<\/b><\/span><\/h4>\n
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MiCheck<\/b><\/span>\u00ae<\/sup><\/b><\/span> Prostate as an additional test to aid the clinical decision to proceed to biopsy<\/b><\/span>