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A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.

ABSTRACT: BACKGROUND:There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety. METHODS AND MATERIALS:This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48?months; however, this has now been extended to 66?months. A sample size of 600 participants is required. DISCUSSION:The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.

SUBMITTER: Szewczyk-Bieda M

PROVIDER: S-EPMC6868804 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.

Szewczyk-Bieda Magdalena M Wei Cheng C Coll Katherine K Gandy Stephen S Donnan Peter P Ragupathy Senthil Kumar Arcot SKA Singh Paras P Wilson Jennifer J Nabi Ghulam G

Trials 20191121 1

<h4>Background</h4>There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.<h4>Methods and materials</h4>This is a prospective multicentre study of pre-biopsy mpMRI dia ...[more]

PMID: 31752954

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Project description:Texture features based on the spatial relationship of pixels, known as the gray-level co-occurrence matrix (GLCM), may play an important role in providing the accurate classification of suspected prostate cancer. The purpose of this study was to use quantitative imaging parameters of pre-biopsy multiparametric magnetic resonance imaging (mpMRI) for the prediction of clinically significant prostate cancer. This was a prospective study, recruiting 200 men suspected of having prostate cancer. Participants were imaged using a protocol-based 3T MRI in the pre-biopsy setting. Radiomics parameters were extracted from the T2WI and ADC texture features of the gray-level co-occurrence matrix were delineated from the region of interest. Radical prostatectomy histopathology was used as a reference standard. A Kruskal-Wallis test was applied first to identify the significant radiomic features between the three groups of Gleason scores (i.e., G1, G2 and G3). Subsequently, the Holm-Bonferroni method was applied to correct and control the probability of false rejections. We compared the probability of correctly predicting significant prostate cancer between the explanatory GLCM radiomic features, PIRADS and PSAD, using the area under the receiver operation characteristic curves. We identified the significant difference in radiomic features between the three groups of Gleason scores. In total, 12 features out of 22 radiomics features correlated with the Gleason groups. Our model demonstrated excellent discriminative ability (C-statistic = 0.901, 95%CI 0.859-0.943). When comparing the probability of correctly predicting significant prostate cancer between explanatory GLCM radiomic features (Sum Variance T2WI, Sum Entropy T2WI, Difference Variance T2WI, Entropy ADC and Difference Variance ADC), PSAD and PIRADS via area under the ROC curve, radiomic features were 35.0% and 34.4% more successful than PIRADS and PSAD, respectively, in correctly predicting significant prostate cancer in our patients (p < 0.001). The Sum Entropy T2WI score had the greatest impact followed by the Sum Variance T2WI. Quantitative GLCM texture analyses of pre-biopsy MRI has the potential to be used as a non-invasive imaging technique to predict clinically significant cancer in men suspected of having prostate cancer.

Project description:Take Home Message In biopsy-naïve patients suspected for prostate cancer, we propose that in case of nonsuspicious multiparametric magnetic resonance imaging (mpMRI), one could abstain from systematic biopsies after careful shared decision-making. Systematic biopsies add a substantial number of clinically significant prostate cancer cases and should not be omitted in case of suspicious mpMRI. Background It remains uncertain whether transrectal ultrasound (TRUS)-guided systematic biopsies can be omitted and rely solely on multiparametric magnetic resonance imaging–targeted biopsies (MRI-TBx) in biopsy-naïve men suspected of prostate cancer (PCa). Objective To compare PCa detection in biopsy-naïve men between systematic biopsy and MRI-TBx. Design, setting, and participants A prospective cohort study was conducted in a Dutch teaching hospital. Consecutive patients with suspected PCa, no history of biopsy, and no clinical suspicion of metastasis underwent both TRUS-guided systematic biopsies and MRI-TBx by multiparametric magnetic resonance imaging (mpMRI)-ultrasound fusion, including sham biopsies in case of negative mpMRI. Outcome measurements and statistical analysis Clinically significant PCa (csPCa), defined as group ≥2 on the International Society of Urological Pathology grading, was detected. Results and limitations The overall prevalence of csPCa, irrespective of biopsy technique, was 37.4% (132/353) in our population. MRI-TBx were performed in 263/353 (74.5%) patients with suspicious mpMRI (Prostate Imaging Reporting and Data System [PI-RADS] ≥3). The detection rates for csPCa were 39.5% for MRI-TBx and 42.9% for systematic biopsies. The added values, defined as the additional percentages of patients with csPCa detected by adding one biopsy technique, were 8.7% for the systematic biopsies and 5.3% for MRI-TBx. In patients with nonsuspicious mpMRI, five cases (6%) of csPCa were found by systematic biopsies. Conclusions This study in biopsy-naïve patients suspected for PCa showed that systematic biopsies have added value to MRI-TBx alone in patients with mpMRI PI-RADS >2. Patient summary We studied magnetic resonance imaging (MRI)-guided prostate biopsy for diagnosing prostate cancer and compared it with the standard method of prostate biopsy. Standard systematic biopsies cannot be omitted in patients with suspicious MRI, as they add to the detection of significant prostate cancer.

Project description:BackgroundMultiparametric magnetic resonance imaging (mpMRI) has shown promise to improve detection of prostate cancer over conventional methods. However, most studies do not describe whether the location of mpMRI lesions match that of cancer found at biopsy, which may lead to an overestimation of accuracy.ObjectiveTo quantitate the effect of mapping locations of mpMRI lesions to locations of positive biopsy cores on the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of mpMRI.Design setting and participantWe retrospectively identified patients having mpMRI of the prostate preceding prostate biopsy at three centres from 2013 to 2016. Men with targetable lesions on imaging underwent directed biopsy in addition to systematic biopsy. We correlated locations of positive mpMRI lesions with those of positive biopsy cores, defining a match when both were in the same sector of the prostate. We defined positive mpMRI as Prostate Imaging Reporting and Data System (PI-RADS) score ≥4 and significant cancer at biopsy as grade group ≥2.Outcome measurements and statistical analysisSensitivity, specificity, PPV, and NPV were calculated with and without location matching.Results and limitationsOf 446 patients, 247 (55.4%) had positive mpMRI and 232 (52.0%) had significant cancer at biopsy. Sensitivity and NPV for detecting significant cancer with location matching (both 63.4%) were decreased compared with those without location matching (77.6% and 73.9%, respectively). Of the 85 significant cancers not detected by mpMRI, most were of grade group 2 (64.7%, 55/85).ConclusionsWe report a 10-15% decrease in sensitivity and NPV when location matching was used to detect significant prostate cancer by mpMRI. False negative mpMRI remains an issue, highlighting the continued need for biopsy and for improving the standards around imaging quality and reporting.Patient summaryThe true accuracy of multiparametric magnetic resonance imaging (mpMRI) must be determined to interpret results and better counsel patients. We mapped the location of positive mpMRI lesions to where cancer was found at biopsy and found, when compared with matching to cancer anywhere in the prostate, that the accuracy of mpMRI decreased by 10-15%.

Project description:BACKGROUND:Multiparametric MRI (mpMRI) became recognised in investigating those with suspected prostate cancer between 2010 and 2012; in the USA, the preventative task force moratorium on PSA screening was a strong catalyst. In a few short years, it has been adopted into daily urological and oncological practice. The pace of clinical uptake, born along by countless papers proclaiming high accuracy in detecting clinically significant prostate cancer, has sparked much debate about the timing of mpMRI within the traditional biopsy-driven clinical pathways. There are strongly held opposing views on using mpMRI as a triage test regarding the need for biopsy and/or guiding the biopsy pattern. OBJECTIVE:To review the evidence base and present a position paper on the role of mpMRI in the diagnosis and management of prostate cancer. METHODS:A subgroup of experts from the ESUR Prostate MRI Working Group conducted literature review and face to face and electronic exchanges to draw up a position statement. RESULTS:This paper considers diagnostic strategies for clinically significant prostate cancer; current national and international guidance; the impact of pre-biopsy mpMRI in detection of clinically significant and clinically insignificant neoplasms; the impact of pre-biopsy mpMRI on biopsy strategies and targeting; the notion of mpMRI within a wider risk evaluation on a patient by patient basis; the problems that beset mpMRI including inter-observer variability. CONCLUSIONS:The paper concludes with a set of suggestions for using mpMRI to influence who to biopsy and who not to biopsy at diagnosis. KEY POINTS:• Adopt mpMRI as the first, and primary, investigation in the workup of men with suspected prostate cancer. • PI-RADS assessment categories 1 and 2 have a high negative predictive value in excluding significant disease, and systematic biopsy may be postponed, especially in men with low-risk of disease following additional risk stratification. • PI-RADS assessment category lesions 4 and 5 should be targeted; PI-RADS assessment category lesion 3 may be biopsied as a target, as part of systematic biopsies or may be observed depending on risk stratification.

Dataset Information

A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.

Publications

A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol.

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