scholarly journals Re-evaluating the diagnostic efficacy of PSA as a referral test to detect clinically significant prostate cancer in contemporary MRI-based image-guided biopsy pathways

2021 ◽  
pp. 205141582110590
Author(s):  
Artitaya Lophatananon ◽  
Alexander Light ◽  
Nicholas Burns-Cox ◽  
Angus Maccormick ◽  
Joseph John ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Predictive Value ◽  
Histological Grade ◽  
Specific Antigen ◽  
Added Value ◽  
Reference Ranges ◽  
Level Of Evidence ◽  
Image Guided ◽  
Guided Biopsy ◽  
Clinically Significant

Introduction: Modern image-guided biopsy pathways at diagnostic centres have greatly refined the investigations of men referred with suspected prostate cancer. However, the referral criteria from primary care are still based on historical prostate-specific antigen (PSA) cut-offs and age-referenced thresholds. Here, we tested whether better contemporary pathways and biopsy methods had improved the predictive utility value of PSA referral thresholds. Methods: PSA referral thresholds, age-referenced ranges and PSA density (PSAd) were assessed for positive predictive value (PPV) in detection of clinically significant prostate cancer (csPCa – histological ⩾ Grade Group 2). Data were analysed from men referred to three diagnostics centres who used multi-parametric magnetic resonance imaging (mpMRI)-guided prostate biopsies for disease characterisation. Findings were validated in a separate multicentre cohort. Results: Data from 2767 men were included in this study. The median age, PSA and PSAd were 66.4 years, 7.3 ng/mL and 0.1 ng/mL2, respectively. Biopsy detected csPCa was found in 38.7%. The overall area under the curve (AUC) for PSA was 0.68 which is similar to historical performance. A PSA threshold of ⩾ 3 ng/mL had a PPV of 40.3%, but this was age dependent (PPV: 24.8%, 32.7% and 56.8% in men 50–59 years, 60–69 years and ⩾ 70 years, respectively). Different PSA cut-offs and age-reference ranges failed to demonstrate better performance. PSAd demonstrated improved AUC (0.78 vs 0.68, p < 0.0001) and improved PPV compared to PSA. A PSAd of ⩾ 0.10 had a PPV of 48.2% and similar negative predictive value (NPV) to PSA ⩾ 3 ng/mL and out-performed PSA age-reference ranges. This improved performance was recapitulated in a separate multi-centre cohort ( n = 541). Conclusion: The introduction of MRI-based image-guided biopsy pathways does not appear to have altered PSA diagnostic test characteristics to positively detect csPCa. We find no added value to PSA age-referenced ranges, while PSAd offers better PPV and the potential for a single clinically useful threshold (⩾0.10) for all age groups. Level of evidence: IV

scholarly journals Accuracy of Tumour-Associated Circulating Endothelial Cells as a Screening Biomarker for Clinically Significant Prostate Cancer

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1064 ◽  
Author(s):  
Sebastian Chakrit Bhakdi ◽  
Prapat Suriyaphol ◽  
Ponpan Thaicharoen ◽  
Sebastian Tobias Karl Grote ◽  
Chulaluk Komoltri ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Endothelial Cells ◽  
Predictive Value ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Circulating Endothelial Cells ◽  
Index Test ◽  
Psa Testing ◽  
Diagnostic Potential ◽  
Clinically Significant

Even though more than 350,000 men die from prostate cancer every year, broad-based screening for the disease remains a controversial topic. Guidelines demand that the only commonly accepted screening tool, prostate-specific antigen (PSA) testing, must be followed by prostate biopsy if results are elevated. Due to the procedure’s low positive predictive value (PPV), however, over 80% of biopsies are performed on healthy men or men with clinically insignificant cancer—prompting calls for new ways of vetting equivocal PSA readings prior to the procedure. Responding to the challenge, the present study investigated the diagnostic potential of tumour-associated circulating endothelial cells (tCECs), which have previously been described as a novel, blood-based biomarker for clinically significant cancers. Specifically, the objective was to determine the diagnostic accuracy of a tCEC-based blood test to detect clinically significant prostate cancer (defined as Gleason score ≥ 3 + 4) in high-risk patients. Performed in a blinded, prospective, single-centre set-up, it compared a novel tCEC index test with transrectal ultrasound-guided biopsy biopsy as a reference on a total of 170 patients and found that a tCEC add-on test will almost double the PPV of a standalone PSA test (32% vs. 17%; p = 0.0012), while retaining a negative predictive value above 90%.

A single centre service evaluation of the pre-biopsy mpMRI pathway for prostate cancer diagnosis

2022 ◽  
pp. 205141582110659
Author(s):  
Mark Kong ◽  
Louise Lee ◽  
Kevin Mulcahy ◽  
Arumugam Rajesh
Keyword(s):  
Prostate Cancer ◽  
Cancer Diagnosis ◽  
Waiting Times ◽  
Specific Antigen ◽  
Service Evaluation ◽  
Level Of Evidence ◽  
Prostate Cancer Diagnosis ◽  
Psa Density ◽  
Tertiary Centre ◽  
Clinically Significant

Aim: To study the efficacy and impact of the local pre-biopsy multiparametric magnetic resonance imaging (mpMRI) pathway for prostate cancer diagnosis. Methods: In this tertiary centre, 570 patients had prostate mpMRI across a 6-month period in 2019. A total of 511 patients met inclusion criteria for retrospective analysis. MRI reporting used the Prostate Imaging-Reporting and Data System (PI-RADS) v2.1. These were assessed alongside histological outcomes and diagnostic times. PI-RADS ⩾ 3 were recommended for biopsy consideration. Gleason scoring ⩾ 3 + 4 and 3 + 3 were used to define clinically and non-clinically significant prostate cancer (csPCa and nsPCa), respectively. Results: Overall prostate cancer prevalence was 40% (204/511, csPCa in 31.1%) with an overall biopsy avoidance of 32.1% (164/511). Around 69.7% (356/511) scored PI-RADS ⩾ 3 and 30.3% (155/511) scored PI-RADS 1–2. About 22.6% (35/155) of PI-RADS 1–2 patients proceeded to biopsy, demonstrating a negative predictive value of 91.43% for csPCa. For PI-RADS ⩾ 3 patients, 63.4% (197/312) of those biopsied had cancer (Gleason ⩾ 3 + 3), with 50% (156/312) demonstrating csPCa. Around 76.7% (102/133) of PI-RADS 5, 35.3% (48/136) of PI-RADS 4, 14.0% (6/43) of PI-RADS 3 and 8.6% (3/35) of PI-RADS 1–2 scores demonstrated csPCa. Overall median prostate-specific antigen (PSA) density was 0.15 ng/mL2 (IQR: 0.10–0.27/mL2). PSA density were significantly different across PI-RADS cohorts ( H = 118.8, p < 0.0001) and across all three biopsy outcomes ( H = 99.72, p < 0.0001). Only 34.3% (119/347) of biopsied patients met the NHS 28-day standard. MRI acquisition and reporting met the 14-day local standard in 96.1% (491/511). The biopsy was the most delayed component with a median of 20 days (IQR: 8–43). Conclusion: Pre-biopsy mpMRI with PI-RADS scoring safely avoided biopsy in almost one-third (32.1%) of patients. The use of PSA-density in risk stratifying PI-RADS 3 lesions has informed local practice in the period 2020–2021, with implementation of a PSA-density threshold of 0.12 ng/mL2. Biopsy scheduling issues and anaesthetic requirements need to be overcome to improve diagnostic waiting times. Level of evidence: 2

Obstacles in prostate cancer screening: Current issues and future solutions

2018 ◽  
Vol 12 (2) ◽  
pp. 111-116
Author(s):  
Benjamin Patel ◽  
Seshadri Sriprasad ◽  
Jeffrey Cadeddu ◽  
Arron Thind ◽  
Abhay Rane
Keyword(s):  
Prostate Cancer ◽  
Prostate Cancer Screening ◽  
Specific Antigen ◽  
Diagnostic Value ◽  
Good Evidence ◽  
Screening Methods ◽  
Level Of Evidence ◽  
Specific Mortality ◽  
Cancer Specific Mortality ◽  
Clinically Significant

Prostate cancer is the most common cancer in men and is associated with unacceptably high mortality rates, yet an accurate and acceptable screening programme that detects clinically significant prostate cancer remains elusive. Although there is good evidence that prostate-specific antigen (PSA)-based screening lowers prostate cancer-specific mortality, especially when conducted at high intensity, the harm caused by overinvestigation, overdiagnosis and overtreatment of clinically insignificant cases arguably outweighs these benefits. Several attempts have therefore been made to improve screening, enhancing the diagnostic value of PSA and identifying novel modalities for screening. Here, we provide a comprehensive review of the benefits and harms, and analyse which of these novel screening methods show most promise. Level of evidence: 5, expert opinion

scholarly journals Independent Evaluation of the Respective Predictive Values for High-Grade Prostate Cancer of Clinical Information and RNA Biomarkers after Upfront MRI and Image-Guided Biopsies

Cancers ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 285 ◽  
Author(s):  
Mathieu Roumiguié ◽  
Guillaume Ploussard ◽  
Léonor Nogueira ◽  
Eric Bruguière ◽  
Olivier Meyrignac ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Information ◽  
Added Value ◽  
High Grade ◽  
Clinical Predictors ◽  
Predictive Values ◽  
Image Guided ◽  
Prostate Biopsies ◽  
Independent Evaluation ◽  
Clinically Significant

Upfront MRI is taking the lead in the diagnosis of clinically significant prostate cancer, while few image-guided biopsies (IGBs) fail to demonstrate clinically significant prostate cancer. The added value of innovative biomarkers is not confirmed in this context. We analysed SelectMDx-v2 (MDx-2) in a cohort of upfront MRI and image-guided biopsy patients. Participants included patients who received a trans-rectal elastic-fusion registration IGB on the basis of DRE, PSA, PCA3, and PCPT-2.0 risk evaluation. Pre-biopsy MRI DICOM archives were reviewed according to PI-RADS-v2. Post-massage first-void urine samples stored in the institutional registered bio-repository were commercially addressed to MDxHealth to obtain MDx-2 scores. Univariate and multivariate analyses were conducted with the detection on IGB of high-grade (ISUP 2 and higher) as the dependent variable. High-grade cancer was demonstrated in 32/117 (27.4%) patients (8/2010–8/2018). Age, prostate volume, biopsy history, MDx-2, and PI-RADS-v2 scores significantly related to the detection of high-grade cancer. MDx-2 scores and the clinical variables embedded into MDx-2 scores were analysed in multivariate analysis to complement PI-RADS-v2 scores. The two combinations outperformed PI-RADS-v2 alone (AUC-ROC 0.67 vs. 0.73 and 0.80, respectively, p < 0.05) and calibration curves confirmed an adequate prediction. Similar discrimination (C-statistics, p = 0.22) was observed in the prediction of high-grade cancer, thereby questioning the respective inputs and added values of biomarkers and clinical predictors in MDx-2 scores. Based on the results of this study, we can conclude that instruments of prediction developed for systematic prostate biopsies, including those that incorporate innovative biomarkers, must be reassessed and eventually confirmed in the context of upfront MRI and IGB.

scholarly journals Clinical use of the SelectMDx urinary-biomarker test with or without mpMRI in prostate cancer diagnosis: a prospective, multicenter study in biopsy-naïve men

2021 ◽  
Author(s):  
Rianne J. Hendriks ◽  
Marloes M. G. van der Leest ◽  
Bas Israël ◽  
Gerjon Hannink ◽  
Anglita YantiSetiasti ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Stratification ◽  
Specific Antigen ◽  
Low Grade ◽  
Diagnostic Study ◽  
High Grade ◽  
Net Benefit ◽  
Conditional Strategy ◽  
Detection Rates ◽  
Guided Biopsy

Abstract Background Risk stratification in men with suspicion of prostate cancer (PCa) requires reliable diagnostic tests, not only to identify high-grade PCa, also to minimize the overdetection of low-grade PCa, and reduction of “unnecessary” prostate MRIs and biopsies. This study aimed to evaluate the SelectMDx test to detect high-grade PCa in biopsy-naïve men. Subsequently, to assess combinations of SelectMDx test and multi-parametric (mp) MRI and its potential impact on patient selection for prostate biopsy. Methods This prospective multicenter diagnostic study included 599 biopsy-naïve patients with prostate-specific antigen level ≥3 ng/ml. All patients underwent a SelectMDx test and mpMRI before systematic transrectal ultrasound-guided biopsy (TRUSGB). Patients with a suspicious mpMRI also had an in-bore MR-guided biopsy (MRGB). Histopathologic outcome of TRUSGB and MRGB was used as reference standard. High-grade PCa was defined as ISUP Grade Group (GG) ≥ 2. The primary outcome was the detection rates of low- and high-grade PCa and number of biopsies avoided in four strategies, i.e., (1) SelectMDx test-only, (2) mpMRI-only, (3) SelectMDx test followed by mpMRI when SelectMDx test was positive (conditional strategy), and (4) SelectMDx test and mpMRI in all (joint strategy). A positive SelectMDx test outcome was a risk score of ≥−2.8. Decision curve analysis (DCA) was performed to assess clinical utility. Results Prevalence of high-grade PCa was 31% (183/599). Thirty-eight percent (227/599) of patients had negative SelectMDx test in whom biopsy could be avoided. Low-grade PCa was not detected in 35% (48/138) with missing 10% (18/183) high-grade PCa. Yet, mpMRI-only could avoid 49% of biopsies, not detecting 4.9% (9/183) of high-grade PCa. The conditional strategy reduces the number of mpMRIs by 38% (227/599), avoiding biopsy in 60% (357/599) and missing 13% (24/183) high-grade PCa. Low-grade PCa was not detected in 58% (80/138). DCA showed the highest net benefit for the mpMRI-only strategy, followed by the conditional strategy at-risk thresholds >10%. Conclusions SelectMDx test as a risk stratification tool for biopsy-naïve men avoids unnecessary biopsies in 38%, minimizes low-grade PCa detection, and misses only 10% high-grade PCa. Yet, using mpMRI in all patients had the highest net benefit, avoiding biopsy in 49% and missing 4.9% of high-risk PCa. However, if mpMRI availability is limited or expensive, using mpMRI-only in SelectMDx test positive patients is a good alternative strategy.

scholarly journals Analysis of risk factors for determining the need for prostate biopsy in patients with negative MRI

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Linghui Liang ◽  
Feng Qi ◽  
Yifei Cheng ◽  
Lei Zhang ◽  
Dongliang Cao ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Detection Efficiency ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Multivariable Logistic Regression Analysis ◽  
Detection Rates ◽  
Prostate Biopsies ◽  
Clinically Significant ◽  
Definition Of ◽  
Medical University

AbstractTo analyze the clinical characteristics of patients with negative biparametric magnetic resonance imaging (bpMRI) who didn’t need prostate biopsies (PBs). A total of 1,012 male patients who underwent PBs in the First Affiliated Hospital of Nanjing Medical University from March 2018 to November 2019, of 225 had prebiopsy negative bpMRI (defined as Prostate Imaging Reporting and Data System (PI-RADS 2.1) score less than 3). The detection efficiency of clinically significant prostate cancer (CSPCa) was assessed according to age, digital rectal examination (DRE), prostate volume (PV) on bpMRI, prostate-specific antigen (PSA) and PSA density (PSAD). The definition of CSPCa for Gleason score > 6. Univariate and multivariable logistic regression analysis were used to identify predictive factors of absent CSPCa on PBs. Moreover, absent CSPCa contained clinically insignificant prostate cancer (CIPCa) and benign result. The detection rates of present prostate cancer (PCa) and CSPCa were 27.11% and 16.44%, respectively. Patients who were diagnosed as CSPCa had an older age (P < 0.001), suspicious DRE (P < 0.001), a smaller PV (P < 0.001), higher PSA value (P = 0.008) and higher PSAD (P < 0.001) compared to the CIPCa group and benign result group. PSAD < 0.15 ng/ml/cm3 (P = 0.004) and suspicious DRE (P < 0.001) were independent predictors of absent CSPCa on BPs. The negative forecast value of bpMRI for BP detection of CSPCa increased with decreasing PSAD, mainly in patients with naive PB (P < 0.001) but not in prior negative PB patients. 25.33% of the men had the combination of negative bpMRI, PSAD < 0.15 ng/ml/cm3 and PB naive, and none had CSPCa on repeat PBs. The incidence of PB was determined, CSPCa was 1.59%, 0% and 16.67% in patients with negative bpMRI and PSAD < 0.15 ng/ml/cm3, patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and biopsy naive and patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and prior negative PB, separately. We found that a part of patients with negative bpMRI, a younger age, no suspicious DRE and PSAD < 0.15 ng/ml/cm3 may securely avoid PBs. Conversely PB should be considered in patients regardless of negative bpMRI, especially who with a greater age, obviously suspicious DRE, significantly increased PSA value, a significantly small PV on MRI and PSAD > 0.15 ng/ml/cm3.

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