The CADMUS trial: A paired cohort, blinded study comparing multiparametric ultrasound targeted biopsies with multiparametric MRI targeted biopsies in the detection of clinically significant prostate cancer

Prostate cancer (PCa) is the most common non-cutaneous cancer diagnosed in males. Traditional tools for screening and diagnosis, such as prostate-specific antigen, digital rectal examination and conventional transrectal ultrasound (TRUS), present low accuracy for PCa detection. Multiparametric MRI has become a game changer in the PCa diagnosis pathway and MRI-targeted biopsies are currently recommended for males at risk of clinically significant PCa, even in biopsy-naïve patients. Recent advances in ultrasound have also emerged with the goal to provide a readily accessible and cost-effective tool for detection of PCa. These newer techniques include elastography and contrast-enhanced ultrasound, as well as improved B-mode and Doppler techniques. These modalities can be combined to define a novel ultrasound approach, multiparametric ultrasound. High frequency Micro-ultrasound has emerged as a promising imaging technology for PCa diagnosis. Initial results have shown high sensitivity of Micro-ultrasound in detecting PCa in addition to its potential in improving the accuracy of targeted biopsies, based on targeting under real-time visualization, rather than relying on cognitive/fusion software MRI-transrectal ultrasound-guided biopsy.

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Multiparametric MRI-Targeted TRUS Prostate Biopsies Using Visual Registration

BioMed Research International ◽

10.1155/2014/819360 ◽

2014 ◽

Vol 2014 ◽

pp. 1-11 ◽

Cited By ~ 24

Author(s):

Philippe Puech ◽

Adil Ouzzane ◽

Vianney Gaillard ◽

Nacim Betrouni ◽

Benoit Renard ◽

...

Keyword(s):

Prostate Cancer ◽

Diagnostic Yield ◽

Transrectal Ultrasound ◽

Multiparametric Mri ◽

Ultrasound Guided ◽

Prostate Biopsies ◽

Multiparametric Prostate Mri ◽

Clinically Significant ◽

Prostate Cancers ◽

Targeted Biopsies

Prebiopsy multiparametric prostate MRI (mp-MRI), followed by transrectal ultrasound-guided (TRUS-G) target biopsies (TB) of the prostate is a key combination for the diagnosis of clinically significant prostate cancers (CSPCa), to avoid prostate cancer (PCa) overtreatment. Several techniques are available for guiding TB to the suspicious mp-MRI targets, but the simplest, cheapest, and easiest to learn is “cognitive,” with visual registration of MRI and TRUS data. This review details the successive steps of the method (target detection, mp-MRI reporting, intermodality fusion, TRUS guidance to target, sampling simulation, sampling, TRUS session reporting, and quality insurance), how to optimize each, and the global indications of mp-MRI-targeted biopsies. We discuss the diagnostic yield of visually-registered TB in comparison with conventional biopsy, and TB performed using other registration methods.

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The CADMUS trial: A paired cohort, blinded study comparing multiparametric ultrasound targeted biopsies with multiparametric MRI targeted biopsies in the detection of clinically significant prostate cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.5008 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 5008-5008

Author(s):

Alistair Grey ◽

Rebecca Scott ◽

Bina Shah ◽

Peter Acher ◽

Sidath Liyanage ◽

...

Keyword(s):

Prostate Cancer ◽

Diagnostic Performance ◽

Point Of Care ◽

Low Cost ◽

Reporting Quality ◽

Multiparametric Mri ◽

Lesion Detection ◽

Gleason Grade ◽

Clinically Significant ◽

Targeted Biopsies

5008 Background: Multiparametric MRI (mpMRI) of the prostate followed by targeted biopsy is recommended in men at risk of prostate cancer. Dissemination of this pathway may be limited by cost, variable scan and reporting quality, and contraindicated in the presence of metallic implants and claustrophobia. Multi-parametric ultrasound (mpUSS) is a point of care test with low cost that combines b-mode, colour Doppler, elastography and contrast enhancement. CADMUS compared the diagnostic performance of mpUSS to mpMRI. Methods: CADMUS recruited 370 patients from seven sites to a prospective, multicentre, paired-cohort trial (ISRCTN 38541912). Ethics committee approval was obtained. Patients underwent both mpUSS and mpMRI independently, each with a positive test defined as a Likert score of >3. Those with either a positive mpUSS or mpMRI, or both, were advised to undergo targeted biopsies. Reporting of each scan was carried out blind to the other and prior to biopsy; patients advised for biopsy were blinded to which test was positive. The order of mpUSS and mpMRI targeting was randomised. Primary outcomes were proportion of positive tests and detection of clinically significant cancer (csPCa) defined as Gleason >4+3 of any length and/or maximum cancer core length of >6mm of any grade [PROMIS definition1]. Results: 306 completed both mpUSS and mpMRI. Agreement in lesion detection between mpUSS and mpMRI was 73.2% (kappa 0.06, p = 0.14). 257 with positive results on mpUSS, mpMRI or both had targeted biopsies. Agreement on detection of csPCa was 91.1% (expected 59.8%, kappa 0.78, p < 0.01). Overall, mpUSS detected 4.3% fewer csPCa than mpMRI (95% CI = [-8.3%, -1.5%]; p = 0.042 [Bonferroni correction]). mpUSS detected 7.2% (6/83) csPCa missed by mpMRI; mpMRI detected 20.5% (17/83) csPCa that mpUSS missed. At a less stringent definition of significant cancer, Gleason grade >3+4 of any length (definition 3), agreement was 89.1% (expected 55.6%, kappa 0.75, p < 0.01) mpUSS detected 5.4% fewer definition 3 cancers than mpMRI overall. mpUSS detected 7% (7/99) definition 3 cancers that mpMRI missed; mpMRI detected 21% (21/99) definition 3 cancers that mpUSS missed. Conclusions: The CADMUS trial shows mpUSS has a diagnostic performance approaching that of mpMRI and significant cancer detection is improved by the use of both scans over mpMRI alone. Clinical trial information: 38541912. [Table: see text]

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Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy

BMJ Open ◽

10.1136/bmjopen-2020-041427 ◽

2021 ◽

Vol 11 (2) ◽

pp. e041427

Author(s):

Biming He ◽

Rongbing Li ◽

Dongyang Li ◽

Liqun Huang ◽

Xiaofei Wen ◽

...

Keyword(s):

Prostate Cancer ◽

Detection Rate ◽

Three Dimensional ◽

Multiparametric Mri ◽

Fusion Method ◽

Targeted Biopsy ◽

Cognitive Fusion ◽

Single Centre ◽

Clinically Significant ◽

Randomised Controlled

IntroductionThe classical pathway for diagnosing prostate cancer is systematic 12-core biopsy under the guidance of transrectal ultrasound, which tends to underdiagnose the clinically significant tumour and overdiagnose the insignificant disease. Another pathway named targeted biopsy is using multiparametric MRI to localise the tumour precisely and then obtain the samples from the suspicious lesions. Targeted biopsy, which is mainly divided into cognitive fusion method and software-based fusion method, is getting prevalent for its good performance in detecting significant cancer. However, the preferred targeted biopsy technique in detecting clinically significant prostate cancer between cognitive fusion and software-based fusion is still beyond consensus.Methods and analysisThis trial is a prospective, single-centre, randomised controlled and non-inferiority study in which all men suspicious to have clinically significant prostate cancer are included. This study aims to determine whether a novel three-dimensional matrix positioning cognitive fusion-targeted biopsy is non-inferior to software-based fusion-targeted biopsy in the detection rate of clinically significant cancer in men without a prior biopsy. The main inclusion criteria are men with elevated serum prostate-specific antigen above 4–20 ng/mL or with an abnormal digital rectal examination and have never had a biopsy before. A sample size of 602 participants allowing for a 10% loss will be recruited. All patients will undergo a multiparametric MRI examination, and those who fail to be found with a suspicious lesion, with the anticipation of half of the total number, will be dropped. The remaining participants will be randomly allocated to cognitive fusion-targeted biopsy (n=137) and software-based fusion-targeted biopsy (n=137). The primary outcome is the detection rate of clinically significant prostate cancer for cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy in men without a prior biopsy. The clinically significant prostate cancer will be defined as the International Society of Urological Pathology grade group 2 or higher.Ethics and disseminationEthical approval was obtained from the ethics committee of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. The results of the study will be disseminated and published in international peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (NCT04271527).

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Computer-Aided Diagnosis Improves the Detection of Clinically Significant Prostate Cancer on Multiparametric-MRI: A Multi-Observer Performance Study Involving Inexperienced Readers

Diagnostics ◽

10.3390/diagnostics11060973 ◽

2021 ◽

Vol 11 (6) ◽

pp. 973

Author(s):

Valentina Giannini ◽

Simone Mazzetti ◽

Giovanni Cappello ◽

Valeria Maria Doronzio ◽

Lorenzo Vassallo ◽

...

Keyword(s):

Prostate Cancer ◽

Computer Aided Diagnosis ◽

Multiparametric Mri ◽

Performance Study ◽

Predictive Values ◽

Cad System ◽

Computer Aided ◽

Clinically Significant ◽

Sensitivity Specificity ◽

Aided Diagnosis

Recently, Computer Aided Diagnosis (CAD) systems have been proposed to help radiologists in detecting and characterizing Prostate Cancer (PCa). However, few studies evaluated the performances of these systems in a clinical setting, especially when used by non-experienced readers. The main aim of this study is to assess the diagnostic performance of non-experienced readers when reporting assisted by the likelihood map generated by a CAD system, and to compare the results with the unassisted interpretation. Three resident radiologists were asked to review multiparametric-MRI of patients with and without PCa, both unassisted and assisted by a CAD system. In both reading sessions, residents recorded all positive cases, and sensitivity, specificity, negative and positive predictive values were computed and compared. The dataset comprised 90 patients (45 with at least one clinically significant biopsy-confirmed PCa). Sensitivity significantly increased in the CAD assisted mode for patients with at least one clinically significant lesion (GS > 6) (68.7% vs. 78.1%, p = 0.018). Overall specificity was not statistically different between unassisted and assisted sessions (94.8% vs. 89.6, p = 0.072). The use of the CAD system significantly increases the per-patient sensitivity of inexperienced readers in the detection of clinically significant PCa, without negatively affecting specificity, while significantly reducing overall reporting time.

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