Multiparametric MRI in men with clinical suspicion of prostate cancer undergoing repeat biopsy: a prospective comparison with clinical findings and histopathology

2017 ◽  
Vol 59 (3) ◽  
pp. 371-380 ◽  
Author(s):  
Lars Boesen ◽  
Nis Nørgaard ◽  
Vibeke Løgager ◽  
Ingegerd Balslev ◽  
Henrik S Thomsen
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Clinical Findings ◽  
High Association ◽  
Prospective Comparison ◽  
Insignificant Cancer ◽  
Lesion Level ◽  
Clinically Significant ◽  
Better Than

Background Multiparametric magnetic resonance imaging (mpMRI) can improve detection of clinically significant prostate cancer (csPCa). Purpose To compare mpMRI score subgroups to systematic transrectal ultrasound-guided biopsies (TRUSbx) and prostate-specific antigen (PSA)-based findings for detection of csPCa in men undergoing repeat biopsies. Material and Methods MpMRI was performed prior to re-biopsy in 289 prospectively enrolled patients. All underwent repeat TRUSbx followed by targeted biopsies (MRITB) of any mpMRI-identified lesion. MpMRI suspicion grade, PSA level, and density (PSAd) were compared with biopsy results and further matched to the radical prostatectomy (RP) specimen if available. Results PCa was detected in 128/289 (44%) patients with median age, PSA, and prior negative TRUSbx of 64 (interquartile range [IQR] = 59–67), 12.0 ng/mL (IQR = 8.3–19.1), and 2 (IQR = 1–3), respectively. TRUSbx detected PCa in 108/289 (37%) patients, of which 49 (45%) had insignificant cancer. MRITB was performed in 271/289 (94%) patients and detected PCa in 96 (35%) with 78 (81%) having csPCa. MpMRI scores showed a high association between suspicion level and biopsy results on both lesion and patient level ( P < 0.001). MpMRI was better than PSA and PSAd ( P < 0.001) to identify patients with missed csPCa. In total, 64/128 (50%) patients underwent RP; 60/64 had csPCa. MpMRI was significantly better in predicting csPCa on RP compared with TRUSbx ( P = 0.019) as MRITB and TRUSbx correctly identified 47/60 (78%) and 35/60 (58%) patients, respectively. Conclusion MpMRI improves detection of missed csPCa and suspicion scores correlate well with biopsy and RP results on both patient and lesion level.

Multiparametric ultrasound and micro-ultrasound in prostate cancer: a comprehensive review

2021 ◽  
Author(s):  
Adriano Basso Dias ◽  
Ciara O’Brien ◽  
Jean-Michel Correas ◽  
Sangeet Ghai
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Digital Rectal Examination ◽  
High Sensitivity ◽  
Cost Effective ◽  
Cognitive Fusion ◽  
Clinically Significant ◽  
Multiparametric Ultrasound ◽  
Targeted Biopsies

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.

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%.

scholarly journals Profiling of Circulating microRNAs in Prostate Cancer Reveals Diagnostic Biomarker Potential

Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 188 ◽  
Author(s):  
Jacob Fredsøe ◽  
Anne K. I. Rasmussen ◽  
Peter Mouritzen ◽  
Marianne T. Bjerre ◽  
Peter Østergren ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Minimally Invasive ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Digital Rectal Examination ◽  
Area Under The Curve ◽  
Diagnostic Tools ◽  
Test Set ◽  
Localized Disease ◽  
Clinically Significant

Early detection of prostate cancer (PC) is paramount as localized disease is generally curable, while metastatic PC is generally incurable. There is a need for improved, minimally invasive biomarkers as current diagnostic tools are inaccurate, leading to extensive overtreatment while still missing some clinically significant cancers. Consequently, we profiled the expression levels of 92 selected microRNAs by RT-qPCR in plasma samples from 753 patients, representing multiple stages of PC and non-cancer controls. First, we compared plasma miRNA levels in patients with benign prostatic hyperplasia (BPH) or localized prostate cancer (LPC), versus advanced prostate cancer (APC). We identified several dysregulated microRNAs with a large overlap of 59 up/down-regulated microRNAs between BPH versus APC and LPC versus APC. Besides identifying several novel PC-associated dysregulated microRNAs in plasma, we confirmed the previously reported upregulation of miR-375 and downregulation of miR-146a-5p. Next, by randomly splitting our dataset into a training and test set, we identified and successfully validated a novel four microRNA diagnostic ratio model, termed bCaP (miR-375*miR-33a-5p/miR-16-5p*miR-409-3p). Combined in a model with prostate specific antigen (PSA), digital rectal examination status, and age, bCaP predicted the outcomes of transrectal ultrasound (TRUS)-guided biopsies (negative vs. positive) with greater accuracy than PSA alone (Training: area under the curve (AUC), model = 0.84; AUC, PSA = 0.63. Test set: AUC, model = 0.67; AUC, PSA = 0.56). It may be possible in the future to use this simple and minimally invasive bCaP test in combination with existing clinical parameters for a more accurate selection of patients for prostate biopsy.

scholarly journals Systematic and MRI-Cognitive Targeted Transperineal Prostate Biopsy Accuracy in Detecting Clinically Significant Prostate Cancer after Previous Negative Biopsy and Persisting Suspicion of Malignancy

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 57
Author(s):  
Alvydas Vėželis ◽  
Gediminas Platkevičius ◽  
Marius Kinčius ◽  
Liutauras Gumbys ◽  
Ieva Naruševičiūtė ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Targeted Biopsy ◽  
Negative Biopsy ◽  
Prostate Biopsies ◽  
Clinically Significant ◽  
Systematic Biopsy ◽  
Targeted Biopsies

Background and objectives: Overdiagnosis, overtreatment, and the need for repeated procedures caused by transrectal ultrasound guided prostate biopsies and their related complications places a heavy burden on healthcare systems. This was a prospective cohort validating study to access the clinical accuracy of systematic and MRI-cognitive targeted transperineal prostate biopsies in detecting clinically significant prostate cancer after a previous negative biopsy and persistent suspicion of malignancy. The primary goal was to assess the ability of multiparametric magnetic resonance imaging (mpMRI) to detect clinically significant prostate cancer with an additional goal to assess the diagnostic value of systematic and MRI-cognitive transperineal biopsies. Materials and Methods: In total, 200 patients were enrolled who had rising serum prostate specific antigen (PSA) levels for at least 4 months after a previous negative transrectal ultrasound (TRUS) biopsy. All eligible men underwent 1.5T prostate mpMRI, reported using the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2), followed by a 20-region transperineal prostate systematic biopsy and additional targeted biopsies. Results: Systematic 20-core transperineal prostate biopsies (TPBs) were performed for 38 (19%) patients. Systemic 20-core TPB with additional cognitive targeted biopsies were performed for 162 (81%) patients. Clinically significant prostate cancer (csPC) was detected for 31 (15.5%) patients, of which 20 (64.5%) cases of csPC were detected by systematic biopsy, eight (25.8%) cases were detected by targeted biopsy, and three (9.7%) both by systematic and targeted biopsies. Conclusions: Cognitive mpMRI guided transperineal target biopsies increase the detection rate of clinically significant prostate cancer after a previously negative biopsy. However, in a repeat prostate biopsy setting, we recommend applying a cognitive targeted biopsy with the addition of a systematic biopsy.

Are men with larger prostates and bothersome voiding symptoms less likely to have significant prostate cancer?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4656-4656
Author(s):  
C. R. Porter ◽  
J. Wright ◽  
L. Borden ◽  
K. Jason ◽  
K. Latchemsetty
Keyword(s):  
Prostate Cancer ◽  
Prostate Gland ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Prostate Needle Biopsy ◽  
Gland Volume ◽  
Men 2 ◽  
Voiding Symptoms ◽  
Clinically Significant ◽  
Cap Analysis

4656 Background: Gleason Sum (GS) predicts clinically significant prostate cancer (CAP) and prostate specific antigen (PSA) survival in men undergoing prostatectomy for CAP. BPH can also elevate PSA. Objective: evaluate prostate gland volume (PV) and American Urologic Symptom Score (AUASS) in men undergoing prostate needle biopsy (PNB) to detect CAP. Analysis endpoints: 1) CAP and 2) GS ≥7. Methods: From 1/2000–7/2005, 1,078 men undergoing PNB were prospectively examined. Urinary voiding symptoms were measured by AUASS. All men were examined by 1 surgeon: DRE and Transrectal Ultrasound (TRUS) were given levels of suspicion (LOS) from 1 = low suspicion (smooth DRE, homogeneous TRUS) to 5 = high suspicion (hard DRE, hypoechoic lesion). LOS ≥3 was abnormal. Prebiopsy parameters: PSA, DRE, age, race, biopsy history, prostate volume (PV), TRUS lesion, and AUASS. All men had 10-core biopsy. 1) Predictors for CAP were evaluated by Univariate (UVA) and multivariate (MVA) analysis (logistic regression) for 1,078 men. 2) Predictors for GS≥7 were evaluated in men with no prior biopsy (NOPB). Results: Median PSA = 5.4 ng/ml (mean 10.4), 38% and 52% had abnormal TRUS & DRE respectively. Mean patient age = 64 years. Mean AUASS = 10.4. Positive biopsy rate = 38%. AUASS: 47% had low symptoms scores (<7), 39% had moderate scores (8–19), and 14% had severe scores (20–35). UVA & MVA (N = 1,078) showed that PSA was not an independent predictor of CAP (p = 0.18), but abnormal DRE, age, low AUASS, no prior biopsy (NOPB), race (AA), abnormal TRUS, and low PV were all independent predictors (p < 0.03). Subset MVA analysis of men in PSA range of 2.5–10 (N = 738), demonstrated that low AUASS (p = 0.05) & low PV (p = 0.00001) were predictors of CAP, while DRE, NOPB, and age were also independent predictors. MVA of men with NOPB (N = 790), indicated that low PV, PSA, DRE, and Age were independent predictors for CAP (p < 0.0001). The multivariate risk of having GS ≥7 on biopsy was independently associate with both low PV (p = 0.001) and abnormal DRE (p = 0.001). The relationship between PV and GS ≥7 showed that for every 1 cc increase in gland volume the risk of GS ≥7 CAP decreases by 2.2%. Conclusions: Men with smaller prostates are more likely to have cancer and are more likely to have significant disease. No significant financial relationships to disclose.

scholarly journals Usefulness of MRI targeted prostate biopsy for detecting clinically significant prostate cancer in men with low prostate-specific antigen levels

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Seokhwan Bang ◽  
Jiwoong Yu ◽  
Jae Hoon Chung ◽  
Wan Song ◽  
Minyong Kang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Multivariate Analyses ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Targeted Biopsy ◽  
Resonance Imaging ◽  
Ultrasound Guided ◽  
Detection Rates ◽  
Clinically Significant

AbstractWe aimed to evaluate the detection rates of prostate cancer (PCa) and clinically significant PCa (csPCa) using magnetic resonance imaging-targeted biopsy (MRI-TBx) in men with low prostate-specific antigen (PSA) levels (2.5–4.0 ng/mL). Clinicopathologic data of 5502 men with PSA levels of 2.5–10.0 ng/mL who underwent transrectal ultrasound-guided biopsy (TRUS-Bx) or MRI-TBx were reviewed. Participants were divided into four groups: LP-T [low PSA (2.5–4.0 ng/mL) and TRUS-Bx, n = 2018], LP-M (low PSA and MRI-TBx, n = 186), HP-T [high PSA (4.0–10.0 ng/mL) and TRUS-Bx, n = 2953], and HP-M (high PSA and MRI-TBx, n = 345). The detection rates of PCa and csPCa between groups were compared, and association of biopsy modality with detection of PCa and csPCa in men with low PSA levels were analyzed. The detection rates of PCa (20.0% vs. 38.2%; P < 0.001) and csPCa (11.5% vs. 32.3%; P < 0.001) were higher in the LP-M group than in the LP-T group. Conversely, there were no significant differences in the detection rates of PCa (38.2% vs. 43.2%; P = 0.263) and csPCa (32.3% vs. 39.4%; P = 0.103) between the LP-M and HP-M groups. Multivariate analyses revealed that using MRI-TBx could predict the detection of csPCa (odds ratio 2.872; 95% confidence interval 1.996‒4.132; P < 0.001) in men with low PSA levels. In summary, performing MRI-TBx in men with low PSA levels significantly improved the detection rates of PCa and csPCa as much as that in men with high PSA levels.

scholarly journals Hypoehoic lesions on Transrectal Ultrasound and its correlation to Gleason grade in the diagnosis of Clinically Significant Prostate Cancer: A Prospective Study

2021 ◽  
Author(s):  
Manas Sharma ◽  
Rajendra B. Nerli ◽  
Sree Harsha Nutalapati ◽  
Shridhar C. Ghagane
Keyword(s):  
Prostate Cancer ◽  
Statistical Analysis ◽  
Prospective Study ◽  
Tertiary Care ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Gleason Grade ◽  
Psa Testing ◽  
Hypoechoic Lesion ◽  
Clinically Significant

Abstract Context The importance of hypoechoic lesions on transrectal ultrasound (TRUS) merits re-assessment in the present era of widespread prostate-specific antigen (PSA) testing. Aims We aimed to investigate the predictive accuracy of hypoechoic lesions on TRUS of prostate in the diagnosis of prostate cancer and to examine the association of hypoechoic lesions with the aggressiveness of prostate cancer. Settings and Design This prospective study was conducted in a tertiary care center in South India from November 2017 to December 2019. Methods and Material We included 151 patients undergoing TRUS-guided 12-core prostate biopsy in view of raised serum PSA with or without suspicious digital rectal examination (DRE) findings in the study. Age, DRE findings, serum PSA level, TRUS findings, and histopathology reports were documented. These were compared between patients with and without hypoechoic lesions on TRUS. Statistical Analysis Used The statistical analysis for this study was performed using SPSS v20.0 software. Results Among 151 men, prostate cancer was diagnosed in 68 (45.03%) with mean age at presentation 69.81 ± 6.49 years. Fifty-eight cases (38.41%) had hypoechoic lesion on TRUS and the cancer detection rate (68.96%) amongst this group was significantly higher than in those without hypoechoic lesion (p <0.0001). Patients with hypoechoic lesion were more likely to have higher grade cancer. Abnormal DRE findings and hypoechoic lesion on TRUS were independent predictors of a clinically significant cancer (p <0.05). Conclusion Hypoechoic lesion on TRUS can be considered as an indicator of clinically significant prostate cancer.

Comparing magnetic resonance imaging/ultrasound-fusion biopsy and systemic 12-core transrectal ultrasound biopsy for whole gland pathology.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 84-84
Author(s):  
Daniel Su ◽  
Arvin George ◽  
Minhaj Siddiqui ◽  
Soroush Rais-Bahrami ◽  
Lambros Stamatakis ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Prostate Biopsy ◽  
Core Biopsy ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Low Grade ◽  
High Grade ◽  
Fusion Biopsy ◽  
Clinically Significant

84 Background: Historically, pathologic findings from standard 12-core prostate biopsies are upgraded in 25 to 33% of patients after radical prostatectomy (RP). MRI/US fusion prostate biopsy has been shown to upgrade prostate cancer compared to standard 12-core biopsy in 32% of patients. MRI/US fusion biopsy may offer a more accurate representation of whole gland pathology. We evaluate the rate of pathologic upgrade in standard 12-core biopsy and MRI/US fusion biopsy when compared with whole gland pathology from RP. Methods: Patients who underwent random prostate biopsy, fusion biopsy and subsequently RP for prostate cancer from 2012 to 2013 were included. Pathology was reviewed by a single pathologist. The cohort was divided into clinically significant high-grade (Gleason score 4+3 or higher) and clinically insignificant low-grade (Gleason score 3+4 or lower) sub cohorts. Pathological upgrade was defined as any increase in Gleason sum or primary Gleason score. McNemar’s test was used to compare the proportion of patients who were upgraded from random biopsy to RP versus the proportion that were upgraded from fusion biopsy to RP. Results: Sixty eight patients underwent 12-core and fusion prostate biopsy then subsequently RP. Mean prostate-specific antigen was 9.2ng/ml. There are total of 43 patients with clinically insignificant low-grade and 25 patients with clinically significant high-grade. Fusion biopsy upgraded 19 patients (28%) compared to 12-core biopsy, eight of these patients had negative 12-core biopsy. Pathology on the RP specimen upgraded 18 of the 12-core results (26%) compare to only eight fusion biopsy results (11%). (p =0.0095) 14 patients (20%) who had clinically insignificant low-grade disease on 12-core biopsy were upgraded to clinically significant high-grade on RP. Only two patients (3%) with clinically insignificant low-grade from fusion biopsy were upgraded on RP. (p< 0.0005) Conclusions: Prostate cancer detected on MRI/US fusion prostate biopsy has significantly lower rates of pathologic upgrade than standard 12-core biopsy when both were compared to prostatectomy specimens. MRI/US fusion biopsy may represent whole gland pathology more accurately compared to 12-core biopsy.

Does PSA level affect the choice of prostate puncture methods among MRI-ultrasound fusion targeted biopsy, transrectal ultrasound systematic biopsy or the combination of both?

2021 ◽  
pp. 20210312
Author(s):  
Yunyun Liu ◽  
Lin Dong ◽  
Lihua Xiang ◽  
Boyang Zhou ◽  
Hanxiang Wang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Statistical Significance ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Targeted Biopsy ◽  
Detection Rates ◽  
Detection Approach ◽  
Clinically Significant ◽  
Histopathological Results ◽  
Systematic Biopsy

Objectives: To explore whether prostate-specific antigen (PSA) affects the choice of prostate puncture methods by comparing MRI-ultrasound fusion targeted biopsy (MRI-TBx) with transrectal ultrasound systematic biopsy (TRUS-SBx) in the detection of prostate cancer (PCa), clinically significant prostate cancer (csPCa) and non-clinically significant prostate cancer (nsPCa) in different PSA groups (<10.0,10.0–20.0 and>20.0 ng ml−1). Methods: A total of 190 patients with 215 lesions who underwent both MRI-TBx and TRUS-SBx were included in this retrospective study. PSA was measured pre-operatively and stratified to three levels. The detection rates of PCa, csPCa and nsPCa through different methods (MRI-TBx, TRUS-SBx, or MRI-TBx +TRUS SBx) were compared with stratification by PSA. Results: Among the 190 patients, the histopathological results revealed PCa in 126 cases, including 119 csPCa. In PSA <10.0 ng ml−1 group, although the detection rates of PCa and csPCa by MRI-TBx were higher than those of TRUS-SBx, no significant differences were observed (p = 0.741; p = 0.400). In PSA 10.0–20.0 ng ml−1 group, difference between the detection rate of csPCa with TRUS-SBx and the combined method was statistically significant (p = 0.044). As for PSA >20.0 ng ml−1, MRI-TBx had a higher csPCa rate than TRUS-SBx with no statistical significance noted (p = 0.600). Conclusion: MRI-TBx combined with TRUS-SBx could be suitable as a standard detection approach for csPCa in patients with PSA 10.0–20.0 ng ml−1. As for PSA >20.0 and <10.0 ng ml−1, both MRI-TBx and TRUS-SBx might provide effective solutions for tumor detection. Advances in knowledge: This study gives an account of choosing appropriate prostate puncture methods through PSA level.

scholarly journals A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017863 ◽  
Author(s):  
Veeru Kasivisvanathan ◽  
Fatima Jichi ◽  
Laurence Klotz ◽  
Arnauld Villers ◽  
Samir S Taneja ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Alternative Pathway ◽  
Specific Antigen ◽  
Transrectal Ultrasound ◽  
Digital Rectal Examination ◽  
Classical Pathway ◽  
Targeted Biopsy ◽  
Ultrasound Guided ◽  
Trus Biopsy ◽  
Clinically Significant

IntroductionThe classical pathway for the diagnosis of prostate cancer is transrectal ultrasound-guided (TRUS) biopsy of the prostate initiated on the basis of a raised prostate-specific antigen (PSA). An alternative pathway is to perform multi-parametricMRI (MPMRI) to localise cancer and to use this information to influence the decision for, and conduct of, a subsequent biopsy, known as an MPMRI-targeted biopsy. An MPMRI pathway has been shown to detect a similar or greater amount of clinically significant cancer as TRUS biopsy but has several advantages, including the potential to biopsy fewer men with fewer cores.MethodsThis is a pragmatic, international, multicentre, parallel group randomised study in which men are allocated in a 1:1 ratio to an MPMRI or TRUS biopsy pathway. This study will assess whether an MPMRI-targeted biopsy approach is non-inferior to a standard TRUS biopsy approach in the diagnosis of clinically significant cancer.Men in the MRI arm will undergo targeted biopsy of suspicious areas only and no biopsy will be carried out if the MRI is non-suspicious. Men in the TRUS biopsy will undergo a standard 10–12-core TRUS biopsy. The main inclusion criteria are a serum PSA ≤20 ng/mL, a digital rectal examination finding of T2 or less and no prior prostate biopsy.The primary outcome is the proportion of men with clinically significant cancer detected. A sample size of at least 470 patients is required. Key secondary outcomes include the proportion of clinically insignificant cancer detected.Ethics and disseminationEthical approval was obtained from the National Research Ethics Committee East Midlands, Leicester (15/EM/0188). Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study.Registration detailsNCT02380027; Pre-results

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