Progensa™ PCA3 test for prostate cancer detection

Taille, Alexandre de la

doi:10.1586/14737159.7.5.491

Cited by 22 publications

(14 citation statements)

References 29 publications

(24 reference statements)

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“…Noncoding RNAs are often stable in human serum and thus measuring either individual marker RNAs (e.g., by qPCR) or the entire transcriptome (e.g., RNA-seq) may allow the non-invasive generation of reliable and actionable clinical indicators (Tong and Lo, 2006). For example, the lncRNA prostate cancer gene 3 ( PCA3 ) is highly associated with prostate cancer and is routinely used to indicate prostate cancer risk (Progensa PCA3 urine test) in urine samples, thereby avoiding unnecessary prostate biopsies (de la Taille, 2007). …”

Section: Diagnostics and Therapeutic Potential Of Lncrnas In Cancermentioning

confidence: 99%

Long noncoding RNAs and the genetics of cancer

et al. 2013

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Cancer is a disease of aberrant gene expression. While the genetic causes of cancer have been intensively studied, it is becoming evident that a large proportion of cancer susceptibility cannot be attributed to variation in protein-coding sequences. This is highlighted by genome-wide association studies in cancer that reveal that more than 80% of cancer-associated SNPs occur in noncoding regions of the genome. In this review, we posit that a significant fraction of the genetic aetiology of cancer is exacted by noncoding regulatory sequences, particularly by long noncoding RNAs (lncRNAs). Recent studies indicate that several cancer risk loci are transcribed into lncRNAs and these transcripts play key roles in tumorigenesis. We discuss the epigenetic and other mechanisms through which lncRNAs function and how they contribute to each stage of cancer progression, understanding of which will be crucial for realising new opportunities in cancer diagnosis and treatment. Long noncoding RNAs play important roles in almost every aspect of cell biology from nuclear organisation and epigenetic regulation to post-transcriptional regulation and splicing, and we link these processes to the hallmarks and genetics of cancer. Finally, we highlight recent progress and future potential in the application of lncRNAs as therapeutic targets and diagnostic markers.

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Section: Diagnostics and Therapeutic Potential Of Lncrnas In Cancermentioning

confidence: 99%

Long noncoding RNAs and the genetics of cancer

et al. 2013

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“…LncRNAs are often stable in human serum and thus measuring either marker RNAs (e.g., by qPCR) or the entire transcriptome (e.g., RNA-seq) may allow the noninvasive generation of reliable and actionable clinical indicators [45]. For example, the lncRNA prostate cancer gene 3 (PCA3) is highly associated with prostate cancer and is routinely used to indicate prostate cancer risk from urine samples [46]. …”

Section: Lncrnas As Therapeutic Targets and Biomarkersmentioning

confidence: 99%

LncRNAs: New Players in Apoptosis Control

Rossi

Antonangeli

2014

International Journal of Cell Biology

111

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The discovery that the mammalian genome is largely transcribed and that almost half of the polyadenylated RNAs is composed of noncoding RNAs has attracted the attention of the scientific community. Growing amount of data suggests that long noncoding RNAs (lncRNAs) are a new class of regulators involved not only in physiological processes, such as imprinting and differentiation, but also in cancer progression and neurodegeneration. Apoptosis is a well regulated type of programmed cell death necessary for correct organ development and tissue homeostasis. Indeed, cancer cells often show an inhibition of the apoptotic pathways and it is now emerging that overexpression or downregulation of different lncRNAs in specific types of tumors sensitize cancer cells to apoptotic stimuli. In this review we summarize the latest studies on lncRNAs and apoptosis with major attention to those performed in cancer cells and in healthy cells upon differentiation. We discuss the new perspectives of using lncRNAs as targets of anticancer drugs. Finally, considering that lncRNA levels have been reported to have a correlation with specific cancer types, we argue the possibility of using lncRNAs as tumor biomarkers.

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“…In most assays, the ratio of PCA3 mRNA copies per milliliter to PSA mRNA copies per milliliter is multiplied by 1,000 to provide a PCA3 "score. " 24,28 Sokoll et al 29 reported the first multicenter study of PCA3 analytical performance in 2008 using the Gen-Probe assay and concluded that the assay performs well and is insensitive to preanalytical factors. On 17 February 2012, Gen-Probe reported that they had received FDA approval for the PROGENSA PCA3 assay.…”

Section: Analytic Validitymentioning

confidence: 99%

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

Calonge

Klein

Berg

et al. 2014

Genetics in Medicine

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Summary of recommendations:The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend prostate cancer antigen 3 (PCA3) testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination).The EGAPP Working Group found insufficient evidence to recommend PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using PCA3 is deemed "low. " The EGAPP Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.Based on the available evidence, the overall certainty of net health benefit is deemed "low. " The EGAPP Working Group discourages clinical use unless further evidence supports improved clinical outcomes.Rationale: It has been suggested that PCA3 testing in the general male population might lead to earlier diagnosis and management changes (e.g., earlier detection and earlier initiation or higher rates of medical interventions) that improve outcomes. EGAPP Working Group found no direct evidence to support this possibility, so we sought indirect evidence aimed at documenting the extent to which PCA3 testing alters prostate cancer diagnosis or management, alone and in combination with traditional clinical management factors, and the extent to which this testing improves health outcomes.Analytic validity: Assay-related evidence was deemed adequate for the PROGENSA PCA3 assay approved by the US Food and Drug Administration, available from Gen-Probe. Very few studies were available that investigated preanalytical effects, analytical performance, and diagnostic accuracy of other quantitative assays for PCA3.Clinical validity: Evidence on clinical validity was rated inadequate to derive any conclusions about performance of PCA3 testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer, or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination). Furthermore, there was little evidence to derive any conclusions about performance of PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan. Clinical utility:No studies were available to provide direct evidence on the balance of benefits and harms related to PCA3 testing for diagnosis and management in the general male population. Evidence for other populations (e.g., high risk) was not evaluated in the review.

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Progensa™ PCA3 test for prostate cancer detection

Cited by 22 publications

References 29 publications

Long noncoding RNAs and the genetics of cancer

Long noncoding RNAs and the genetics of cancer

LncRNAs: New Players in Apoptosis Control

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes?

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