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Mp77-15 a Multi-centre Randomised Controlled Trial Assessing Whether Mri-targeted Biopsy Is Non-inferior to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Clinically Significant Prostate Cancer in Men Without Prior Biopsy - the Precision Study: Prostate Evaluation for Clinically Important Disease, Sampling Using Image-guidance or Not? (nct02380027)

Year: 2018

Type: article

Abstract: You have accessJournal of UrologyProstate Cancer: Detection & Screening VI1 Apr 2018MP77-15 A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL ASSESSING WHETHER MRI-TARGETED BIOPSY IS NON-INFERIOR TO STANDARD TRANS-RECTAL ULTRASOUND GUIDED BIOPSY FOR THE DIAGNOSIS OF CLINICALLY SIGNIFICANT PROSTATE CANCER IN MEN WITHOUT PRIOR BIOPSY - THE PRECISION STUDY: PROSTATE EVALUATION FOR CLINICALLY IMPORTANT DISEASE, SAMPLING USING IMAGE-GUIDANCE OR NOT? (NCT02380027) Veeru Kasivisvanathan, Antti Rannikko, Marcelo Borghi, Valeria Panebianco, Lance Mynderse, Markku Vaarala, Alberto Briganti, Lars Budäus, Giles Hellawell, Richard Hindley, Monique Roobol, Scott Eggener, Maneesh Ghei, Arnauld Villers, Franck Bladou, Geert Villeirs, Jaspal Virdi, Silvan Boxler, Grégoire Robert, Paras Singh, Wulphert Venderink, Boris Hadaschik, Alain Ruffion, Jim Hu, Daniel Margolis, Sébastien Crouzet, Laurence Klotz, Samir Taneja, Peter Pinto, Inderbir Gill, Clare Allen, Francesco Giganti, Alex Freeman, Steve Morris, Shonit Punwani, Norman Williams, Chris Brew-Graves, Yemisi Takwoingi, Mark Emberton, and Caroline Moore Veeru KasivisvanathanVeeru Kasivisvanathan More articles by this author , Antti RannikkoAntti Rannikko More articles by this author , Marcelo BorghiMarcelo Borghi More articles by this author , Valeria PanebiancoValeria Panebianco More articles by this author , Lance MynderseLance Mynderse More articles by this author , Markku VaaralaMarkku Vaarala More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Lars BudäusLars Budäus More articles by this author , Giles HellawellGiles Hellawell More articles by this author , Richard HindleyRichard Hindley More articles by this author , Monique RoobolMonique Roobol More articles by this author , Scott EggenerScott Eggener More articles by this author , Maneesh GheiManeesh Ghei More articles by this author , Arnauld VillersArnauld Villers More articles by this author , Franck BladouFranck Bladou More articles by this author , Geert VilleirsGeert Villeirs More articles by this author , Jaspal VirdiJaspal Virdi More articles by this author , Silvan BoxlerSilvan Boxler More articles by this author , Grégoire RobertGrégoire Robert More articles by this author , Paras SinghParas Singh More articles by this author , Wulphert VenderinkWulphert Venderink More articles by this author , Boris HadaschikBoris Hadaschik More articles by this author , Alain RuffionAlain Ruffion More articles by this author , Jim HuJim Hu More articles by this author , Daniel MargolisDaniel Margolis More articles by this author , Sébastien CrouzetSébastien Crouzet More articles by this author , Laurence KlotzLaurence Klotz More articles by this author , Samir TanejaSamir Taneja More articles by this author , Peter PintoPeter Pinto More articles by this author , Inderbir GillInderbir Gill More articles by this author , Clare AllenClare Allen More articles by this author , Francesco GigantiFrancesco Giganti More articles by this author , Alex FreemanAlex Freeman More articles by this author , Steve MorrisSteve Morris More articles by this author , Shonit PunwaniShonit Punwani More articles by this author , Norman WilliamsNorman Williams More articles by this author , Chris Brew-GravesChris Brew-Graves More articles by this author , Yemisi TakwoingiYemisi Takwoingi More articles by this author , Mark EmbertonMark Emberton More articles by this author , and Caroline MooreCaroline Moore More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2603AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The place of MRI in the diagnostic pathway is widely debated, particularly in men who have not had a prostate biopsy before. PRECISION aimed to evaluate whether multiparametric MRI and a targeted biopsy only (MRI±TB) was non-inferior to TRUS biopsy in detecting clinically significant prostate cancer in biopsy naive men METHODS PRECISION was a prospective, randomised, non-inferiority trial, carried out in 25 sites in 11 countries. 500 men were randomly allocated to 10-12 core TRUS-biopsy or MRI±TB. Men randomised to MRI±TB underwent MRI followed by targeted biopsy alone (without standard cores) if the PIRADSv2 score was ≥3. Image registration technique was left to local expertise. Men with a PIRADSv2 score of 1-2 were not offered biopsy. The primary outcome was the proportion of men diagnosed with clinically significant cancer (Gleason grade (GG)≥ 3+4), with the non-inferiority margin for the difference in proportions set at -5%. Planned secondary outcomes included the proportion of men with clinically insignificant cancer (GG 3+3) RESULTS Baseline characteristics were similar in both MRI±TB and TRUS biopsy arms for mean age (64 vs 65, respectively), median PSA (6.8 vs 6.5), proportion of men with family history of prostate cancer (19% vs 16%) and proportion of men with abnormal digital rectal examination (14% vs 15%). One third of men avoided biopsy in the MRI arm (71/252, 28%). Clinically significant cancer was detected in 95 (38%) of 252 men in the MRI±TB arm compared to 64 (26%) of 248 men randomised to TRUS-biopsy (intention-to-treat analysis). Adjusting for centre effects, the absolute difference (MRI±TB versus TRUS-biopsy) in the proportion of men diagnosed with clinically significant prostate cancer was 11.8% (2-sided 95% CI 3.7 to 20.0; p = 0.005). The lower bound of the 95% CI for the difference is greater than -5% therefore MRI±TB was non-inferior to TRUS biopsy. Furthermore, the range of 95% CI was consistent with a claim of superiority of MRI±TB over TRUS-biopsy. MRI±TB also diagnosed fewer men with insignificant cancer than TRUS biopsy [23/252 (9%) vs 55/248 (22%), p<0.001] CONCLUSIONS An MRI-targeted approach in biopsy naive men resulted in fewer biopsies, greater detection of clinically significant disease and less detection of insignificant disease © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1033 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Veeru Kasivisvanathan More articles by this author Antti Rannikko More articles by this author Marcelo Borghi More articles by this author Valeria Panebianco More articles by this author Lance Mynderse More articles by this author Markku Vaarala More articles by this author Alberto Briganti More articles by this author Lars Budäus More articles by this author Giles Hellawell More articles by this author Richard Hindley More articles by this author Monique Roobol More articles by this author Scott Eggener More articles by this author Maneesh Ghei More articles by this author Arnauld Villers More articles by this author Franck Bladou More articles by this author Geert Villeirs More articles by this author Jaspal Virdi More articles by this author Silvan Boxler More articles by this author Grégoire Robert More articles by this author Paras Singh More articles by this author Wulphert Venderink More articles by this author Boris Hadaschik More articles by this author Alain Ruffion More articles by this author Jim Hu More articles by this author Daniel Margolis More articles by this author Sébastien Crouzet More articles by this author Laurence Klotz More articles by this author Samir Taneja More articles by this author Peter Pinto More articles by this author Inderbir Gill More articles by this author Clare Allen More articles by this author Francesco Giganti More articles by this author Alex Freeman More articles by this author Steve Morris More articles by this author Shonit Punwani More articles by this author Norman Williams More articles by this author Chris Brew-Graves More articles by this author Yemisi Takwoingi More articles by this author Mark Emberton More articles by this author Caroline Moore More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Source: The Journal of Urology

DOI: 10.1016/j.juro.2018.02.2603

Language: English

Topic: Prostate Cancer Diagnosis and Treatment

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: bronze

Funder: Conquer Cancer Foundation

OpenAlex ID: W2796458110

FWCI:

Cites:

Cited by: 1

Related to: 10