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Estima-se que 20 milhões de homens, a cada ano em USA, são rastreados para cancro da próstata, e mais de 1 milhão são posteriormente encaminhados para biópsia. A decisão de biópsia da glândula da próstata do paciente é feita com base num exame retal digital (DRE), e exames de sangue, tais como PSA (antígeno prostático específico). O diagnóstico de cancro da próstata pode ser difícil em alguns pacientes, particularmente naqueles que têm valores intermediários de PSA (4-10 ng / ml) com DRE normal. Nesses casos, o urologistas deve decidir entre a realização de biópsia ou a colocação do paciente num programa de vigilância activa. Uma vez que 75% das biópsias primárias de próstata não apresentam cancro, evitar procedimentos desnecessários pouparia a dor do paciente e despesas, e ajudaria a evitar potenciais complicações relacionadas ao procedimento, tais como hemorragia e sepsis (infecção séria, por vezes fatal do sangue). Para além disso, as biópsias nem sempre detectam o cancro de próstata quando ela está presente.

Mesmo quando o cancro da próstata é diagnosticado, o estadiamento clínico através de biopsia e avaliação Gleason não se correlaciona necessariamente com o estadiamento patológico. Aproximadamente 50% dos homens cuja doença é pensada ser localizada na próstata antes da cirurgia, apresentam extensão do tumor para além do prostate1, e uma minoria significativa já tem desenvolvida a doença metastática. Determinar quais os tumores agressivos com base na avaliação Gleason da biópsia é particularmente desafiante entre valores intermediários de 6-7. Especificamente, dentro desta "zona cinzenta" de avaliação Gleason, a capacidade de prever a agressividade da doença (como a extensão extracapsular, invasão de vesículas seminais e comprometimento de linfonodos) é limitada, mesmo quando os resultados de uma biópsia da próstata são acoplados com outros parâmetros clínicos, tais como exame físico e níveis de PSA. As necessidades clínicas não resolvidas na detecção do cancro de próstata e avaliação de risco, são a força motriz dos esforços da Metabolon para desenvolver um melhor diagnóstico nesta área.

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O teste de detecção de cancro da Metabolon é baseado na detecção de uma única assinatura metabólica a partir do pellet, a partir de uma pequena amostra de urina pós-DRE. Este teste de alta precisão pode ser realizada antes da biópsia primária (para informar a decisão de realização de biópsia), no momento da biópsia, ou após uma primeira biópsia negativa (para informar a decisão de realização de uma segunda biópsia). O teste também pode ser usado durante o processo de gestão de espera. Uma vez que o teste Metabolon é não-invasivo, fornece informação clínica adicional para orientar o médico na tomada de decisões, e melhorar o manejo do paciente, minimizando o risco para o paciente e a despesa adicional a partir de uma biópsia desnecessária.

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A biópsia é o padrão-ouro para o diagnóstico de cancro da próstata, e a histopatologia da biópsia do paciente é um factor usado para determinar se o cancro está em estágio inicial ou avançado. O teste Metabolon mede um painel de metabolitos na biópsia de tecido de próstata que permite ao médico determinar com mais precisão se o tumor do paciente é agressivo. Este teste é realizado no fluido em que os núcleos de biópsia da próstata estão embebidos previamente ao processamento pelo patologista. Este processo patenteado pela Metabolon para extração de metabólitos a paritr de núcleos de biópsia, não compromete o tecido da biópsia nem altera a morfologia do tecido. O teste Prostarix ™ de avaliação da biópsia de próstata fornece informações clínicas valiosas acerca da agressividade do cancro da próstata do paciente, permitindo melhorar a tomada de decisões na gestão clínica da doença do paciente.

1 Partin AW, Kattan MW, Subong EN, Walsh PC, Wojno KJ, Oesterling JE, et al. Combination of prostate-specific antigen, clinical stage, and Gleason score to predict pathological stage of localized prostate cancer. A multi-institutional update. JAMA 1997;277:1445-51

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