“TREXIT 2020”: why the time to abandon transrectal prostate biopsy starts now

Grummet, Jeremy; Gorin, Michael A.; Popert, Rick; O’Brien, Tim; Lamb, Alastair; Hadaschik, Boris; Radtke, Jan Philipp; Wagenlehner, Florian; Baco, Eduard; Moore, Caroline M.; Emberton, Mark; George, Arvin; Davis, John W.; Szabo, Richard J.; Buckley, Roger; Loblaw, Andrew; Allaway, Matthew; Kastner, Christof; Briers, Erik; Royce, Peter; Frydenberg, Mark; Murphy, Declan; Woo, Henry H.

doi:10.1038/s41391-020-0204-8

Cited by 91 publications

(74 citation statements)

References 28 publications

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“…The ‘TRexit’ (complete cessation of TRUS prostate biopsies) plan is to move away from TR biopsy and introduce LATP biopsy throughout the UK [5]. There was a shift towards TP biopsy even before COVID‐19; over the last 10 years TR biopsy has outnumbered TP with a 4:1 ratio; however, this has moved to a 2:1 ratio over the last 2 years [1].…”

Section: Discussionmentioning

confidence: 99%

A cross‐section of UK prostate cancer diagnostics during the coronavirus disease 2019 (COVID‐19) era – a shifting paradigm?

et al. 2020

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Section: Discussionmentioning

confidence: 99%

A cross‐section of UK prostate cancer diagnostics during the coronavirus disease 2019 (COVID‐19) era – a shifting paradigm?

et al. 2020

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“…Noteworthy is that the use of PSA for general screening has produced an overall reduction in PC mortality but resulted in a ≥ substantial increase in unnecessary biopsies along with the detection of clinically low-risk asymptomatic cancers. With approximately 2 million transrectal ultrasonography-guided prostate biopsies (TRUS-Bx) performed each year in the United States and Europe (19) there is increasing concern over the risk of multi-drug resistant infections which was recently reported to be approximately 10% (20). Collectively, there is much to be gained by introducing more objective biomarker-driven assays into the biopsy decision paradigm and while clinical assessment tools, such as the PCPTRC, have value in assessing risk, these clinical calculators are not designed to be patient speci c.…”

Section: Discussionmentioning

confidence: 99%

Clinical Performance of the ExoDx (EPI) Prostate Intelliscore Test to Predict High-grade Prostate Cancer at Initial Biopsy: A Pooled Analysis of Three Independent Prospective Studies.

Margolis

Brown

Partin

et al. 2020

Preprint

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BACKGROUND The ability to discriminate indolent from clinically significant prostate cancer (PC) in the initial biopsy setting remains an important health issue. ExoDx Prostate(IntelliScore) (EPI), is a non-invasive exosome based liquid biopsy test that quantifies three RNA targets in exosomes from urine. The EPI test is used to help stratify patients for risk of high grade prostate cancer, HGPC (≥ GG2 PC) in men 50 years or older with PSA in the gray zone (2–10 ng/mL). The EPI test has been extensively validated and is included in the NCCN guidelines for prostate cancer early detection. Here we present a pooled meta-analysis from three independent prospective validation studies in men presenting for initial biopsy decision. Age range and PSA level subgroups were also analyzed for EPI performance.METHODS Pooled data from two prospective multi-site validation studies and the control arm of a clinical utility study were analyzed. The data from these three independent trials is presented for men 50 years or older with PSA 2–10 ng/ml presenting for their initial prostate biopsy as well as a subgroup of patients between 55–69 years as recommended by the USPSTF (United States Preventative Services Task Force) and PSA greater than 3 ng/mL as per NCCN 2020 guidelines. Diagnostic needle biopsy outcomes were compared with the EPI score, PSA and both the Prostate Cancer Prevention Trial (PCPT 2.0) and the European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculators. Performance was evaluated using the area under the receiver operating characteristic curve (AUC), negative predictive value (NPV), positive predictive value (PPV), sensitivity and specificity for discriminating ≥ GG2 from GG1 and benign pathology.RESULTS The combined cohort (n = 1212) of initial biopsy subjects had a median age of 63 years, median PSA 5.2 ng/mL and 17% African ancestry. The positive biopsy rate was 52% for ≥ GG1, 30% ≥GG2 and 14% ≥GG3. The EPI AUC of 0.70 was superior to PSA (AUC:0.56), PCPTRC (AUC: 0.62), and ERSPC (AUC: 0.59), (all p-values < 0.001) for discriminating GG2 from GG1 and benign histology. The previously validated cut-point of 15.6 (or alternative 20) would avoid 23% (or 34%) of all prostate biopsies and 30% (or 43%) of “unnecessary” (benign or Gleason 6/GG1) biopsies, with an NPV of 90% (89%). Across the total cohort (n = 1212), only 2.3% (28/1212) or 3.8% (46/1212) of patients would experience delayed detection of ≥ GG2 at the < 15.6 or < 20 threshold, respectively and for GG3, 1% (12/1212) and 1.5% (19/1212) at either cut-point would be delayed. Comparable results were identified when either the USPSTF 55–69 year age limit or NCCN PSA greater than 3 ng/mL were applied.CONCLUSIONS EPI is a non-invasive, easy to use, urine exosome-RNA assay that has been validated across 3 independent prospective multi-center clinical trials with 1212 patients. The test can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease and performs equally well in the larger cohort as well as across the USPSTF and NCCN restricted subgroups. EPI effectively guides the biopsy decision process and improves identification of HGPC independent of PSA and other standard of care factors.

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“…Further, the risk of complications can be further decreased, as transperineal biopsy can also be performed under local anaesthetic with good effect 51 . Such factors prompted a recent call for transperineal biopsy to become the new standard of care 52 . In Australia, and much of the world, this transition is widely recognised, with many urology units already implementing or looking to implement this technique in routine clinical practice 52 …”

Section: Transperineal Biopsy Of the Prostatementioning

confidence: 99%

“…Such factors prompted a recent call for transperineal biopsy to become the new standard of care 52 . In Australia, and much of the world, this transition is widely recognised, with many urology units already implementing or looking to implement this technique in routine clinical practice 52 …”

Section: Transperineal Biopsy Of the Prostatementioning

confidence: 99%

Understanding the diagnosis of prostate cancer

Ong

Bagguley

Yaxley

et al. 2020

Medical Journal of Australia

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Summary Prostate cancer continues to be the most commonly diagnosed cancer, and the second leading cause of cancer death among Australian men. Prostate‐specific antigen testing is personalised (not dichotomous in nature) and its interpretation should take into account the patient's age, symptoms, previous results and medication (eg, 5‐α reductase inhibitors such as dutasteride). Multiparametric magnetic resonance imaging of the prostate has been proven to have a 93% sensitivity for detecting clinically significant prostate cancer. It has the potential to decrease unnecessary prostate biopsies by around 27%. International Society of Urological Pathology (ISUP) grade 1 (Gleason score 6) has been shown to have very little, if any, risk of metastasis ISUP grade 1 (Gleason score 3 +3 = 6) and low percentage ISUP grade 2 (Gleason score 3 + 4 [< 10%] = 7) can be offered active surveillance. The goal of active surveillance is to defer treatment but is still curative when required. With better imaging (magnetic resonance imaging and emerging prostate‐specific membrane antigen positron emission tomography–computed tomography) and transperineal prostate biopsy, more men can be offered screening after discussion of risks and benefits, knowing that overdiagnosis has been minimised and radical treatment is reserved for only the most aggressive disease.

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“TREXIT 2020”: why the time to abandon transrectal prostate biopsy starts now

Cited by 91 publications

References 28 publications

A cross‐section of UK prostate cancer diagnostics during the coronavirus disease 2019 (COVID‐19) era – a shifting paradigm?

A cross‐section of UK prostate cancer diagnostics during the coronavirus disease 2019 (COVID‐19) era – a shifting paradigm?

Clinical Performance of the ExoDx (EPI) Prostate Intelliscore Test to Predict High-grade Prostate Cancer at Initial Biopsy: A Pooled Analysis of Three Independent Prospective Studies.

Understanding the diagnosis of prostate cancer

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