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 ◽  
...  

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

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Seokhwan Bang ◽  
Jiwoong Yu ◽  
Jae Hoon Chung ◽  
Wan Song ◽  
Minyong Kang ◽  
...  

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.


Author(s):  
Adriano Basso Dias ◽  
Ciara O’Brien ◽  
Jean-Michel Correas ◽  
Sangeet Ghai

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.


Diagnostics ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. 188 ◽  
Author(s):  
Jacob Fredsøe ◽  
Anne K. I. Rasmussen ◽  
Peter Mouritzen ◽  
Marianne T. Bjerre ◽  
Peter Østergren ◽  
...  

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.


Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 57
Author(s):  
Alvydas Vėželis ◽  
Gediminas Platkevičius ◽  
Marius Kinčius ◽  
Liutauras Gumbys ◽  
Ieva Naruševičiūtė ◽  
...  

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.


2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
E T Zuling ◽  
S Murali-Krishnan

Abstract Men with high serum prostate specific antigen (PSA) typically undergo standard transrectal ultrasound-guided prostate biopsy (TRUS-biopsy) during which 10 to 12 cores are obtained. TRUS-biopsy can cause side-effects including bleeding, pain, and infection. Multi-parametric MRI (MP-MRI) used as a triage test might allow men to avoid unnecessary TRUS-biopsy and improve diagnostic accuracy. According to the renowned PROMIS study, for clinically significant cancer, MP-MRI was more sensitive and less specific than TRUS-biopsy. In this study, we performed a single centre, retrospective audit on the detection rate of clinically significant cancer among MP-MRI targeted biopsy and compare it with the standard TRUS biopsy. Clinically significant cancer is defined as Gleason score ³ 4 +3 or a maximum cancer core length 6mm or longer. Besides, we also compare the rate of clinically significant cancer in MP-MRI targeted biopsy against the PROMIS study. Through this audit, we found that in 2019, there is a 54% (60 out of 112 patients) of clinically significant cancer in MP-MRI biopsy and 41% (26 out of 64 patients) of clinically significant cancer among standard TRUS biopsy. Comparing it with the PROMIS study in which clinically significant cancer was detected in 38% in the MP-MRI targeted biopsy group and 26% in the standard-biopsy group, the adjusted difference in our study (13%) is similar to PROMIS study which is 12%. In conclusion, our study reaffirms that MP-MRI targeted biopsy reduce over-diagnosis of clinically insignificant prostate cancer and improve detection of clinically significant cancer.


2021 ◽  
pp. 20210312
Author(s):  
Yunyun Liu ◽  
Lin Dong ◽  
Lihua Xiang ◽  
Boyang Zhou ◽  
Hanxiang Wang ◽  
...  

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.


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