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10 april 2019: Bron:  Journal of the National Comprehensive Cancer Network

Voor het vaststellen van prostaatkanker en de agressiviteit daarvan zijn verschillende testen en diagnosetechnieken. De bekendste is de PSA meting maar die is zeker niet de betrouwbaarste. Onderzoekers hebben een systematisch onderzoek gedaan naar een aantal testen en diagnosetechnieken. En daarvan de effectiviteit en betrouwbaarheid gemeten.

De onderzoekers vonden bewijs voor klinisch bruikbaar gebruik voor de Prostate Health Index (PHI), 4Kscore test, MRI, OncotypeDX, Decipher test, Prolaris, ConfirmMDx, Progensa PCA3, NADiA ProsVue, and ProMark.

De urinetest SelectMDx staat er nog niet bij maar is in Europa inmiddels als bruikbare effectieve diagnosetest goedgekeurd. 

Geen bewijs voor klinische effectiviteit werd gevonden voor Prostarix, ProstaVysion, Prostate Core Mitomic Test, en Mi-Prostate Score.

Figure 1.

Het studierapport: Evaluation of New Tests and Interventions for Prostate Cancer Management: A Systematic Review is volledig en gratis in te zien.

Hier het abstract van de studie plus referentielijst:

Evaluation of New Tests and Interventions for Prostate Cancer Management: A Systematic Review

in Journal of the National Comprehensive Cancer Network

Authors: Ghadeer Olleik 1 , 1 , Wassim Kassouf 1 , 1 , Armen Aprikian 1 , 1 , Jason Hu 1 , 1 , Marie Vanhuyse 1 , 1 , Fabio Cury 1 , 1 , Stuart Peacock 1 , Elin Bonnevier 1 , Ebba Palenius 1 and Alice Dragomir 1 , 1
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Volume/Issue:
Volume 16: Issue 11
Online Publication Date:
Nov 2018
DOI:
https://doi.org/10.6004/jnccn.2018.7055

Prostate cancer (PCa) is the second most frequently diagnosed male malignancy worldwide.1 In Canada, PCa accounted for an estimated 21% of all new cancer cases in 2016, with approximately 21,600 new cases diagnosed.2 In the United States, approximately 220,800 men are diagnosed with PCa and 27,000 men die of the disease per year.3

Early detection of PCa results in high cure rates, better outcomes, and lower costs.4,5 Currently, detection and clinical staging depend on serum prostate-specific antigen (PSA) levels, biopsy Gleason score, and T staging (through digital rectal examination and imaging).6,7 However, these assessment tools do not accurately stratify patients with PCa, leading to overdiagnosis and overtreatment.8 Although PSA screening was associated with declining PCa-specific mortality (PCSM),9,10 it increased PCa incidence, leading to overtreatment of clinically insignificant tumors.10,11 In addition to the lack of specificity of PSA testing, biopsy undersampling raised additional concerns.12 Upgrading and downgrading Gleason score post-prostatectomy13,14 is a clear reflection of biopsy sampling error,15 which causes overtreatment of some cases and undertreatment of others.

Although some patients need immediate treatment, up to 60% of patients diagnosed with PCa according to current practice can be managed safely with active surveillance (AS).16 Thus, significant efforts have been made to find new tests and interventions that can differentiate between indolent and aggressive cancer, optimize the use of biopsy, and support the treatment decision.

Many new tests have demonstrated clinical utility and benefit in PCa management. These tests are applied in 4 main decision points: screening, after negative biopsy, after positive biopsy, or after radical treatment. To spare a patient with indolent PCa from an unnecessary biopsy after an elevated PSA test, interventions such as the Prostate Health Index (PHI; Beckman Coulter, Inc.), 4Kscore test (OPKO Health, Inc.), MRI, and Prostarix (Metabolon, Inc.) could be used for screening.17–23 Furthermore, once diagnosed with PCa, patients might benefit from a group of interventions developed to distinguish aggressive cancers (that require treatment) from non-aggressive cancers (that could be observed safely); these interventions include Prolaris (Myriad Genetic Laboratories, Inc.), Decipher test (GenomeDx Biosciences Inc.), OncotypeDX (Genomic Health, Inc.), ProstaVysion (Bostwick Laboratories), MRI, Mi-Prostate Score (MiPS; MLabs), and ProMark (Metamark Genetics, Inc.).12,23–29 Other interventions could help overcome false-positive screening results and sampling errors after a negative biopsy to identify candidates for a repeat biopsy, and these include Progensa PCA3 (Gen-Probe Incorporated), 4Kscore, PHI, MRI, Prostate Core Mitomic Test (PCMT; MDNA Life Sciences Inc.), and ConfirmMDx (MDx Health).23,30–35 Finally, tests have been developed for after radical treatment to assess whether additional treatment is necessary depending on pathologic findings, including Decipher, NADiA ProsVue (IRIS International, Inc.), ProMark, and Prolaris.23,25,36–41

Clinicians would undoubtedly like to consider some of these interventions, due to their potential role in improving risk stratification and outcomes prognostication. Unfortunately, most of these interventions are not used in clinical practice, mainly due to lack of evidence of their clinical benefit, clinical utility, and cost-effectiveness. Many analytical validity and clinical validity studies have been published; however, not many clinical utility studies can be found, which reflect the interventions' usefulness in clinical practice.

The objective of this systematic review was to assess the clinical utility of newly marketed tests for use in PCa management before initial or repeat biopsy (after negative biopsy), after positive biopsy, and post-prostatectomy.

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