MicroRNA profiling as an identification tool of recurrence on prostate cancer patients

Abstract

The prostate cancer is the second most common among men in Brazil (approximately 28% of cases) and in recent years there was an increase in incidence, with high mortality rate. Guidelines established by the Brazilian Society of Urology (SBU) recommend that the diagnosis should be predicted after performing rectal (DRE) and prostate-specific antigen (PSA). The definitive diagnosis is made by biopsy. The radical prostatectomy (RP) is generally indicated for patients with localized cancer, clinically significant and expected survival of at least 10 years. However, a high percentage (30% - 40%) of patients have biochemical recurrence, and most of them present manifestation of metastatic disease. There is still no ideal tumor marker for the diagnosis of prostate cancer, but PSA is the most widely used for biochemical recurrence detection after RP, despite its low specificity. The identification of molecular biomarkers has been an innovative approach in predicting the risk of biochemical recurrence and aggressiveness of prostate cancer. MicroRNAs are potential candidate biomarkers due to their involvement in proliferation, differentiation and cell progression, acting as oncogenes or tumor suppressors. Therefore, our goal is to develop, validate and commercialize a molecular test based on microRNA profiling that can predict with high accuracy the risk of biochemical recurrence and tumor progression in patients who underwent radical prostatectomy. For this, we intend to evaluate the expression of previously selected microRNAs (based on extensive literature search) in prostate tumor tissues of three groups of patients: those who showed no recurrence of cancer, those who had biochemical recurrence without metastasis within 5 years after prostatectomy, and those who developed metastasis. Half of the samples will be examined and form the basis for the development of a molecular classifier based on microRNA signatures. The other part of the samples will be used in the validation of the developed algorithm. ONKOS will count on the partnership and the infrastructure of the Barretos Cancer Hospital and intends to operate in a niche of the molecular diagnostics market hitherto untapped in Brazil, establishing the Gene Expression Profiling technique as a technology platform, focusing on personalized medicine for oncology. Under the pillars of knowledge, open innovation and solution to the client, the company intends to differentiate from the competitors through a high-performance R&D. The development of new techniques for determination of prognostic factors in prostate cancer that allow the clinical decision with objectivity is vital, aiming to individualize treatment, because it reduces the number of unnecessary tests, which are often costly, individualizing treatment, besides allowing a more affordable price than competitors, since it is a national technology. (AU)