Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial.

Published on Apr 1, 2021in JAMA Oncology31.777
· DOI :10.1001/JAMAONCOL.2020.7589
Laurence Klotz87
Estimated H-index: 87
(Sunnybrook Health Sciences Centre),
Joseph L. Chin64
Estimated H-index: 64
(London Health Sciences Centre)
+ 17 AuthorsMasoom A. Haider1
Estimated H-index: 1
(TGH: Toronto General Hospital)
Sources
Abstract
Importance Magnetic resonance imaging (MRI) with targeted biopsy is an appealing alternative to systematic 12-core transrectal ultrasonography (TRUS) biopsy for prostate cancer diagnosis, but has yet to be widely adopted. Objective To determine whether MRI with only targeted biopsy was noninferior to systematic TRUS biopsies in the detection of International Society of Urological Pathology grade group (GG) 2 or greater prostate cancer. Design, Setting, and Participants This multicenter, prospective randomized clinical trial was conducted in 5 Canadian academic health sciences centers between January 2017 and November 2019, and data were analyzed between January and March 2020. Participants included biopsy-naive men with a clinical suspicion of prostate cancer who were advised to undergo a prostate biopsy. Clinical suspicion was defined as a 5% or greater chance of GG2 or greater prostate cancer using the Prostate Cancer Prevention Trial Risk Calculator, version 2. Additional criteria were serum prostate-specific antigen levels of 20 ng/mL or less (to convert to micrograms per liter, multiply by 1) and no contraindication to MRI. Interventions Magnetic resonance imaging–targeted biopsy (MRI-TB) only if a lesion with a Prostate Imaging Reporting and Data System (PI-RADS), v 2.0, score of 3 or greater was identified vs 12-core systematic TRUS biopsy. Main Outcome and Measures The proportion of men with a diagnosis of GG2 or greater cancer. Secondary outcomes included the proportion who received a diagnosis of GG1 prostate cancer; GG3 or greater cancer; no significant cancer but subsequent positive MRI results and/or GG2 or greater cancer detected on a repeated biopsy by 2 years; and adverse events. Results The intention-to-treat population comprised 453 patients (367 [81.0%] White, 19 [4.2%] African Canadian, 32 [7.1%] Asian, and 10 [2.2%] Hispanic) who were randomized to undergo TRUS biopsy (226 [49.9%]) or MRI-TB (227 [51.1%]), of which 421 (93.0%) were evaluable per protocol. A lesion with a PI-RADS score of 3 or greater was detected in 138 of 221 men (62.4%) who underwent MRI, with 26 (12.1%), 82 (38.1%), and 30 (14.0%) having maximum PI-RADS scores of 3, 4, and 5, respectively. Eighty-three of 221 men who underwent MRI-TB (37%) had a negative MRI result and avoided biopsy. Cancers GG2 and greater were identified in 67 of 225 men (30%) who underwent TRUS biopsy vs 79 of 227 (35%) allocated to MRI-TB (absolute difference, 5%, 97.5% 1-sided CI, −3.4% to ∞; noninferiority margin, −5%). Adverse events were less common in the MRI-TB arm. Grade group 1 cancer detection was reduced by more than half in the MRI arm (from 22% to 10%; risk difference, −11.6%; 95% CI, −18.2% to −4.9%). Conclusions and Relevance Magnetic resonance imaging followed by selected targeted biopsy is noninferior to initial systematic biopsy in men at risk for prostate cancer in detecting GG2 or greater cancers. Trial Registration ClinicalTrials.gov Identifier:NCT02936258
📖 Papers frequently viewed together
2019
2019
4 Authors (Kai Zhang, ..., Ming Liu)
References27
Newest
#1Andrew J. Vickers (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 126
#2Sigrid Carlsson (University of Gothenburg)H-Index: 23
Last. Matthew R. Cooperberg (UCSF: University of California, San Francisco)H-Index: 76
view all 3 authors...
Guidelines now recommend multiparametric magnetic resonance imaging before prostate biopsy in the work-up for patients with elevated prostate specific-antigen. However, use of magnetic resonance imaging for early detection of prostate cancer is not justified by the clinical trial evidence.
Source
#1Antonio C. Westphalen (UCSF: University of California, San Francisco)H-Index: 31
#2Charles E. McCulloch (UCSF: University of California, San Francisco)H-Index: 104
Last. Andrew B. Rosenkrantz (NYU: New York University)H-Index: 63
view all 48 authors...
Background Prostate MRI is used widely in clinical care for guiding tissue sampling, active surveillance, and staging. The Prostate Imaging Reporting and Data System (PI-RADS) helps provide a standardized probabilistic approach for identifying clinically significant prostate cancer. Despite widespread use, the variability in performance of prostate MRI across practices remains unknown. Purpose To estimate the positive predictive value (PPV) of PI-RADS for the detection of high-grade prostate can...
Source
#1Laurence Klotz (Sunnybrook Health Sciences Centre)H-Index: 87
#2Greg Pond (McMaster University)H-Index: 11
Last. Masoom A. Haider (Sunnybrook Health Sciences Centre)H-Index: 45
view all 14 authors...
Abstract Background The initial report from the ASIST trial showed little benefit from targeted biopsy for men on active surveillance (AS) for prostate cancer. Data after 2-yr follow-up are now available for analysis. Objective To determine if there was a difference in the AS failure rate in a 2-yr follow-up period among men undergoing magnetic resonance imaging (MRI) before initial confirmatory biopsy (CBx) compared to those who did not. Design, setting, and participants This is the 2-yr post-C...
Source
#1M. A. PagniezH-Index: 1
#2Veeru Kasivisvanathan (UCL: University College London)H-Index: 18
Last. Jonathan Olivier (CNRS: Centre national de la recherche scientifique)H-Index: 9
view all 6 authors...
Objective:To systematically review the literature on predictive factors for csPCa diagnosis after nMRI in PCa-naive patients.Evidence Acquisition:The Medline and Scopus databases were searched up t...
Source
#4Chris H. Bangma (Erasmus University Medical Center)H-Index: 85
Abstract Context Magnetic resonance imaging (MRI), with or without MRI-targeted biopsy (MRI pathway), is an alternative test to systematic transrectal ultrasonography-guided biopsy in men suspected of having prostate cancer. At present, evidence on which test to use is insufficient to inform detailed evidence-based decision making. Objective To determine the diagnostic accuracy of the index tests MRI only, MRI-targeted biopsy, MRI pathway, and systematic biopsy, as compared with template-guided ...
Source
#1Chandan Das (AIIMS: All India Institute of Medical Sciences)H-Index: 17
#2Abdul Razik (AIIMS: All India Institute of Medical Sciences)H-Index: 6
Last. Sadhna Verma (UC: University of Cincinnati)H-Index: 26
view all 4 authors...
Prostate cancer, unlike other cancers, has been sampled in a non-targeted, systematic manner in the past three decades. On account of the low volume of prostate sampled despite the multiple cores acquired, systematic transrectal (TRUS) biopsy suffered from low sensitivity in picking up clinically significant prostate cancer. In addition, a significant number of cancers of the anterior, lateral peripheral zone, and the apex were missed as these areas were undersampled or missed during this biopsy...
Source
#1Douglas C. Cheung (UHN: University Health Network)H-Index: 2
#2Antonio FinelliH-Index: 54
KEY POINTS Among solid-organ tumours, prostate cancer is alone in being diagnosed via a nontargeted biopsy approach. Systematic transrectal ultrasonography-guided biopsy has been the standard of care to detect clinically important prostate cancer since 1989.[1][1] Yet modern image acquisition and
Source
#1David C. Johnson (UCLA: University of California, Los Angeles)H-Index: 2
#2Steven S. Raman (UCLA: University of California, Los Angeles)H-Index: 33
Last. Robert E. Reiter (UCLA: University of California, Los Angeles)H-Index: 66
view all 15 authors...
Abstract Background Multiparametric magnetic resonance imaging (mpMRI) undoubtedly affects the diagnosis and treatment of localized prostate cancer (CaP). However, clinicians need a better understanding of its accuracy and limitations in detecting individual CaP foci to optimize management. Objective To determine the per-lesion detection rate for CaP foci by mpMRI and identify predictors of tumor detection. Design, setting, and participants We carried out a retrospective analysis of a prospectiv...
Source
#1Marloes van der Leest (Radboud University Nijmegen)H-Index: 11
#2Erik B. CornelH-Index: 23
Last. Jelle O. Barentsz (Radboud University Nijmegen)H-Index: 94
view all 20 authors...
Abstract Background There is growing interest to implement multiparametric magnetic resonance imaging (mpMRI) and MR-guided biopsy (MRGB) for biopsy-naive men with suspected prostate cancer. Objective Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naive men with prostate-specific antigen levels of ≥3 ng/ml. Design, setting, and population A prospective, multicenter, powered, comparative effectiveness study includ...
Source
#1Laurence Klotz (Sunnybrook Health Sciences Centre)H-Index: 87
#2Andrew Loblaw (Sunnybrook Health Sciences Centre)H-Index: 37
Last. Masoom A. Haider (Sunnybrook Health Sciences Centre)H-Index: 45
view all 14 authors...
Abstract Background and objective This study aimed to determine, in men recently diagnosed with grade group 1 (GG1) prostate cancer, if magnetic resonance imaging (MRI) with targeted biopsy could identify a greater proportion of men with GG ≥2 cancer on their confirmatory biopsy compared with systematic biopsies. The study was registered with www.clinicaltrials.gov ( NCT01354171 ). Design, setting, and participants This study is a prospective, randomized, multicenter, open-label trial. Eligible ...
Source
Cited By16
Newest
#1Jos ImmerzeelH-Index: 1
#2Bas Israël (Radboud University Nijmegen)H-Index: 7
Last. Jelle O. Barentsz (Radboud University Nijmegen)H-Index: 94
view all 10 authors...
Abstract null null Background null Transperineal magnetic resonance imaging–transrectal ultrasound fusion guided biopsy (MFGB) is an increasingly popular technique due to increasing rates of biopsy-related infections. However, its widespread implementation has been hampered by the supposed necessity of epidural or general anesthesia. null null null Objective null To demonstrate the technique, feasibility, and results of transperineal MFGB under local anesthesia, in an ambulatory setting without ...
Source
#1Jae Chun Park (UOU: University of Ulsan)
#2Kye Jin Park (UOU: University of Ulsan)H-Index: 12
Last. Jeong Kon Kim (UOU: University of Ulsan)H-Index: 37
view all 5 authors...
BACKGROUND Deep learning-based reconstruction (DLR) can potentially improve image quality by reduction of noise, thereby enabling fast acquisition of magnetic resonance imaging (MRI). However, a systematic evaluation of image quality and diagnostic performance of MRI using short acquisition time with DLR has rarely been investigated in men with prostate cancer. PURPOSE To assess the image quality and diagnostic performance of MRI using short acquisition time with DLR for the evaluation of extrap...
Source
#1Teresa MarsdenH-Index: 1
#2Derek J. Lomas (Mayo Clinic)H-Index: 5
Last. Mieke Van Hemelrijck ('KCL': King's College London)H-Index: 39
view all 20 authors...
INTRODUCTION: The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI. METHODS AND ANALYSIS: The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50-75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI...
Source
#1Jonas Wallström (Sahlgrenska University Hospital)H-Index: 2
#2Kjell Geterud (Sahlgrenska University Hospital)H-Index: 5
Last. Jonas Hugosson (Sahlgrenska University Hospital)H-Index: 64
view all 11 authors...
Abstract null null Background null The Goteborg 2 prostate cancer (PC) screening (G2) trial evaluates screening with prostate-specific antigen (PSA) followed by magnetic resonance imaging (MRI) in case of elevated PSA levels. null null null Objective null To assess the safety of using a 2-yr interval in men who were previously screened positive with PSA but had negative MRI or positive MRI with a negative biopsy. null null null Design, setting, and participants null A total of 61 201 men aged 50...
Source
#1Branimir LodetaH-Index: 3
#2Vladimir Trkulja (University of Zagreb)H-Index: 20
view all 6 authors...
Purpose null To evaluate prostate cancer detection rates with classical trans-rectal ultrasound-guided systematic 10-core biopsies (SB), targeted biopsies (TB) guided by magnetic resonance (MR)/US fusion imaging and their combination in biopsy-naive and patients with previously negative prostate biopsies. We compared pathology results after radical prostatectomy with biopsy findings. null Methods null Consecutive patients with prostate imaging-reporting and data system lesions grade ≥ 3 submitte...
Source
#1Tyler P. Robin (University of Colorado Denver)H-Index: 15
#2Christopher L Geiger (University of Colorado Denver)
Last. Elizabeth R. Kessler (University of Colorado Denver)H-Index: 12
view all 0 authors...
PURPOSE OF REVIEW Prostate cancer is the second most common cancer in men in the USA and several studies suggest more aggressive disease in older patients. However, screening remains controversial, especially in the older patient population. RECENT FINDINGS Aggressive prostate cancers are more common in older men. Screening trial results are conflicting but data suggest an improvement in prostate cancer mortality and increased detection of metastatic disease with screening. When PSA is utilized ...
Source
#3Steven M. Shea (Loyola University Medical Center)H-Index: 17
Background null Men with prior negative prostate biopsies have a lower risk of being diagnosed with prostate cancer in comparison with biopsy-naive men. However, the relative clinical utility of identified lesions on multiparametric magnetic resonance imaging (mpMRI) is uncertain between the 2 settings. null Methods null Patients from the Prospective Loyola University mpMRI (PLUM) Prostate Biopsy Cohort (January 2015 to June 2020) were examined. The detection of any prostate cancer and clinicall...
Source
#1Hendrik Van Poppel (Katholieke Universiteit Leuven)H-Index: 83
#2Renée Hogenhout (Erasmus University Medical Center)H-Index: 2
Last. Monique J. Roobol (Erasmus University Medical Center)H-Index: 74
view all 6 authors...
Abstract null null Context null Overdiagnosis as the argument to stop prostate cancer (PCa) screening is less valid since the introduction of new technologies such as risk calculators (RCs) and magnetic resonance imaging (MRI). These new technologies result in fewer unnecessary biopsy procedures and fewer cases of both overdiagnosis and underdetection. Therefore, we can now adequately respond to the growing and urgent need for a structured risk assessment to detect PCa early. null null null Obje...
Source
#1Jonathan Li (Emory University)
#2Dattatraya Patil (Emory University)H-Index: 13
Last. Christopher P. Filson (Emory Healthcare)H-Index: 22
view all 4 authors...
Abstract null null Purpose null We characterized population-level cancer-specific outcomes for prostate cancer patients based on use of prebiopsy prostate MRI. null null null Methods null Using SEER-Medicare claims, we identified men diagnosed with localized prostate cancer from 2010–2015 and prostate-specific antigen (PSA) null null null null Results null We identified 48,574 patients, where 915 (1.9%) underwent prebiopsy MRI. Patients with prebiopsy MRI had more GG>2 cancer on biopsy (70.0% MR...
Source
#1Silvia D. Chang (UBC: University of British Columbia)H-Index: 24
#2Sangeet Ghai (Women's College Hospital)H-Index: 24
Last. Caroline M. Moore (UCL: University College London)H-Index: 37
view all 6 authors...
Prostate cancer is the second most common malignancy in men worldwide. Systematic transrectal prostate biopsy is commonly used to obtain tissue to establish the diagnosis. However, in recent years, MRI-targeted biopsy (based on an MRI examination performed prior to consideration of biopsy) has been shown to detect more clinically significant cancer and less clinically insignificant cancer compared to systematic biopsy. This approach of performing MRI prior to biopsy has become, or is becoming, a...
Source
This website uses cookies.
We use cookies to improve your online experience. By continuing to use our website we assume you agree to the placement of these cookies.
To learn more, you can find in our Privacy Policy.