The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

Nicholson, Amanda; Mahon, James; Boland, Angela; Beale, Sophie; Dwan, Kerry; Fleeman, Nigel; Hockenhull, Juliet; Dündar, Yenal

doi:10.3310/hta19870

Cited by 67 publications

(87 citation statements)

References 103 publications

(549 reference statements)

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“…Only around 25% of men with an elevated PSA level, defined as> 4.0 ng/mL, are diagnosed with prostate cancer at biopsy, and conversely false-negatives are also common (2). Biopsies frequently miss cancer due to tumor heterogeneity, necessitating the need for multiple repeat biopsies which are potentially hazardous to patients and technically challenging (3). Radical prostatectomies are associated with frequent co-morbidities, including erectile dysfunction and incontinence, but are associated with better survival outcomes that radiation therapy (4).…”

Section: Introductionmentioning

confidence: 99%

Metabolomic Biomarkers of Prostate Cancer: Prediction, Diagnosis, Progression, Prognosis, and Recurrence

Kelly

Heiden

Giovannucci

et al. 2016

Cancer Epidemiology, Biomarkers &Amp; Prevention

103

109

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Metabolite profiling is being increasing employed in the study of prostate cancer as a means of identifying predictive, diagnostic and prognostic biomarkers. This review provides a summary and critique of the current literature. Thirty-three human case-control studies of prostate cancer exploring disease prediction, diagnosis, progression or treatment response were identified. All but one demonstrated the ability of metabolite profiling to distinguish cancer from benign, tumor aggressiveness, cases who recurred, and those who responded well to therapy. In the subset of studies where biomarker discriminatory ability was quantified, high AUCs were reported that would potentially outperform the current gold standards in diagnosis, prognosis and disease recurrence, including PSA testing. There were substantial similarities between the metabolites and the associated pathways reported as significant by independent studies, and important roles for abnormal cell growth, intensive cell proliferation and dysregulation of lipid metabolism were highlighted. The weight of the evidence therefore suggests metabolic alterations specific to prostate carcinogenesis and progression that may represent potential metabolic biomarkers. However, replication and validation of the most promising biomarkers is currently lacking and a number of outstanding methodological issues remain to be addressed in order to maximize the utility of metabolomics in the study of prostate cancer.

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Section: Introductionmentioning

confidence: 99%

Metabolomic Biomarkers of Prostate Cancer: Prediction, Diagnosis, Progression, Prognosis, and Recurrence

Kelly

Heiden

Giovannucci

et al. 2016

Cancer Epidemiology, Biomarkers &Amp; Prevention

103

109

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“…Thus, PCA3-3STA, a PCa-specific expression system, has the potential to target primary or metastatic PCa epithelial cells for imaging, vaccines, or gene therapy. Currently, apart from the Prostate Health Index (phi; Beckman Coulter Inc., Brea, CA, USA) assay based on blood, the Progensa ® PCA3 Assay from Hologic Gen-Probe (Marlborough, MA, USA) is available for analyzing urinary samples, which provides information for clinicians to decide whether or not to recommend a repeat biopsy [35,42]. A PCA3 score is calculated via Progensa ® PCA3 Assay by quantifying PSA and PCA3 transcripts using transcription-mediated amplification in urinary specimens collected post-DRE [36].…”

Section: Pca3 and Its Combinations Of Multiple Biomarkersmentioning

confidence: 99%

Long Non-Coding RNA as Potential Biomarker for Prostate Cancer: Is It Making a Difference?

Deng

Tang

Guo

et al. 2017

IJERPH

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Whole genome transcriptomic analyses have identified numerous long non-coding RNA (lncRNA) transcripts that are increasingly implicated in cancer biology. LncRNAs are found to promote essential cancer cell functions such as proliferation, invasion, and metastasis, with the potential to serve as novel biomarkers of various cancers and to further reveal uncharacterized aspects of tumor biology. However, the biological and molecular mechanisms as well as the clinical applications of lncRNAs in diverse diseases are not completely understood, and remain to be fully explored. LncRNAs may be critical players and regulators in prostate cancer carcinogenesis and progression, and could serve as potential biomarkers for prostate cancer. This review focuses on lncRNA biomarkers that are already available for clinical use and provides an overview of lncRNA biomarkers that are under investigation for clinical development in prostate cancer.

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“…It is adapted from a previous piece of work conducted by the Liverpool Review and Implementation Group (LRiG) and is reproduced here with permission. 106 The classic presentation of the results of a clinical validity study is the so-called 2 × 2 table, as shown in Table 17.…”

Section: Implications For Researchmentioning

confidence: 99%

Automated tests for diagnosing and monitoring cognitive impairment: a diagnostic accuracy review

Aslam

Bates

Dündar

et al. 2016

Health Technol Assess

Self Cite

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BackgroundCognitive impairment is a growing public health concern, and is one of the most distinctive characteristics of all dementias. The timely recognition of dementia syndromes can be beneficial, as some causes of dementia are treatable and are fully or partially reversible. Several automated cognitive assessment tools for assessing mild cognitive impairment (MCI) and early dementia are now available. Proponents of these tests cite as benefits the tests’ repeatability and robustness and the saving of clinicians’ time. However, the use of these tools to diagnose and/or monitor progressive cognitive impairment or response to treatment has not yet been evaluated.ObjectivesThe aim of this review was to determine whether or not automated computerised tests could accurately identify patients with progressive cognitive impairment in MCI and dementia and, if so, to investigate their role in monitoring disease progression and/or response to treatment.Data sourcesFive electronic databases (MEDLINE, EMBASE, The Cochrane Library, ISI Web of Science and PsycINFO), plus ProQuest, were searched from 2005 to August 2015. The bibliographies of retrieved citations were also examined. Trial and research registers were searched for ongoing studies and reviews. A second search was run to identify individual test costs and acquisition costs for the various tools identified in the review.Review methodsTwo reviewers independently screened all titles and abstracts to identify potentially relevant studies for inclusion in the review. Full-text copies were assessed independently by two reviewers. Data were extracted and assessed for risk of bias by one reviewer and independently checked for accuracy by a second. The results of the data extraction and quality assessment for each study are presented in structured tables and as a narrative summary.ResultsThe electronic searching of databases, including ProQuest, resulted in 13,542 unique citations. The titles and abstracts of these were screened and 399 articles were shortlisted for full-text assessment. Sixteen studies were included in the diagnostic accuracy review. No studies were eligible for inclusion in the review of tools for monitoring progressive disease. Eleven automated computerised tests were assessed in the 16 included studies. The overall quality of the studies was good; however, the wide range of tests assessed and the non-standardised reporting of diagnostic accuracy outcomes meant that meaningful synthesis or statistical analysis was not possible.LimitationsThe main limitation of this review is the substantial heterogeneity of the tests assessed in the included studies. As a result, no meta-analyses could be undertaken.ConclusionThe quantity of information available is insufficient to be able to make recommendations on the clinical use of the computerised tests for diagnosing and monitoring MCI and early dementia progression. The value of these tests also depends on the costs of acquisition, training, administration and scoring.Future workResearch is required to establish stable cut-off points for automated computerised tests that are used to diagnose patients with MCI or early dementia. Additionally, the costs associated with acquiring and using these tests in clinical practice should be estimated.Study registrationThe study is registered as PROSPERO CRD42015025410.FundingThe National Institute for Health Research Health Technology Assessment programme.

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The clinical effectiveness and cost-effectiveness of the PROGENSA® prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation

Cited by 67 publications

References 103 publications

Metabolomic Biomarkers of Prostate Cancer: Prediction, Diagnosis, Progression, Prognosis, and Recurrence

Metabolomic Biomarkers of Prostate Cancer: Prediction, Diagnosis, Progression, Prognosis, and Recurrence

Long Non-Coding RNA as Potential Biomarker for Prostate Cancer: Is It Making a Difference?

Automated tests for diagnosing and monitoring cognitive impairment: a diagnostic accuracy review

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