scholarly journals 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 ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041427
Author(s):  
Biming He ◽  
Rongbing Li ◽  
Dongyang Li ◽  
Liqun Huang ◽  
Xiaofei Wen ◽  
...  

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).

2018 ◽  
Vol 20 (4) ◽  
pp. 441
Author(s):  
Fabian Steinkohl ◽  
Anna Katharina Luger ◽  
Renate Pichler ◽  
Jasmin Bektic ◽  
Peter Rehder ◽  
...  

Aim: Prostate biopsies are usually done with transrectal ultrasound (TRUS) in B-mode (B TRUS) but multiparametric MRI (mpMRI) is the gold imaging standard for the visualization of clinically significant prostate cancer (PCa), since a lowPCa detection rate is reported for B TRUS. The aim of this study was to assess the visibility of MRI lesions on B TRUS and to determine which factors may influence the visibility on B TRUS.Material and methods: 142 men with 148 lesions reported on mpMRI underwent a B TRUS/mpMRI fusion targeted biopsy of the prostate and were included in this retrospective study. During the biopsy, images were obtained and stored in the institution’s PACS. These images were reviewed by two radiologists to determine, whether an mpMRI lesion was or was not visible on B TRUS.Results: Overall 92 from 148 mpMRI lesions (62.2%) were visible on B TRUS. The location of the lesion in the prostate, the PIRADS classification of the lesions and the size of the lesion had no significant influence on the visibility on B TRUS. Only the prostate volume had a significant influence on visibility: in smaller prostates significantly more lesions were visible on B TRUS than in large glands (p+0.041; 45.1 ml vs 54 ml).Conclusion: The use of newer high-end ultrasound units as well as experience gained from fusion biopsies enables us to see 62.2 % of all suspicious mpMRI lesions on B TRUS. B TRUS images merit a thorough examination during a conventional biopsy setting.


2017 ◽  
Vol 15 (1) ◽  
pp. e33-e36 ◽  
Author(s):  
Pietro Pepe ◽  
Antonio Garufi ◽  
Giandomenico Priolo ◽  
Michele Pennisi

2021 ◽  
Author(s):  
Victor Mihail Cauni ◽  
Dan Stanescu ◽  
Florin Tanase ◽  
Bogdan Mihai ◽  
Cristian Persu

Aim: Magnetic resonance/ ultrasound fusion targeted biopsy (Tbs) is widely used for diagnosing prostate cancer (PCa). The aim of our study was to compare the cancer detection rate (CDR) and the clinically significant prostate cancer detection rate (csPCa) of the magnetic resonance/ultrasound fusion targeted biopsy with those of the standard systematic biopsy (Sbs) and of the combination of both techniques.Material and methods: A total of 182 patients underwent magnetic resonance/ultrasound fusion Tbs on the prostate for PCa suspicion based on multiparametric magnetic resonance imaging (mMRI) detection of lesions with PI-RADSv2 score ≥3. A total of 78 patients had prior negative biopsies. Tb was performed by taking 2-4 cores from each suspected lesion, followed by Sb with 12 cores. We evaluated the overall detection rate of PCa and clinically significant prostate cancer, defined as any PCa with Gleason score ≥3+4.Results: Median prostate specific antigen (PSA) level pre-biopsy was 7.4 ng/ml and median free-PSA/PSA ratio was 10.2%. Patient median age was 62 years old. PIRADSv2 score was 3 in 54 cases, 4 in 96 cases and 5 in 32 cases. PI-RADS-dependent detection rate of Tbs for scores 3, 4 and 5 was 25.9%, 65.6% and 84.4%, respectively, with csPCa detection rates of 24.1%, 54.2%, and 71.9%. Overall detection rate was 57.1% for Tbs, which increased to 60.4% by adding Sbs results. Detection rate for clinically significant prostate cancer (csPCa) was 48.4% and increased to 51.1% by adding Sbs. Overall detection rate for repeated biopsy was 50% and 68.3% for biopsy in naïve patients. Sbs detection rate was 55.5%, 8 patients having a negative biopsy on Tbs.Conclusions: When Tbs is considered due to a PI-RADS ≥3 lesion on mMRI, combined Tbs + Sbs increases the overall CDR and csPCa detection rates.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Alexandre Peltier ◽  
Fouad Aoun ◽  
Marc Lemort ◽  
Félix Kwizera ◽  
Marianne Paesmans ◽  
...  

Introduction. To compare, in the same cohort of men, the detection of clinically significant disease in standard (STD) cores versus multiparametric magnetic resonance imaging (mpMRI) targeted (TAR) cores.Material and Methods. A prospective study was conducted on 129 biopsy naïve men with clinical suspicion of prostate cancer. These patients underwent prebiopsy mpMRI with STD systematic biopsies and TAR biopsies when lesions were found. The agreement between the TAR and the STD protocols was measured using Cohen’s kappa coefficient.Results. Cancer detection rate of MRI-targeted biopsy was 62.7%. TAR protocol demonstrated higher detection rate of clinically significant disease compared to STD protocol. The proportion of cores positive for clinically significant cancer in TAR cores was 28.9% versus 9.8% for STD cores (P<0.001). The proportion of men with clinically significant cancer and the proportion of men with Gleason score 7 were higher with the TAR protocol than with the STD protocol (P=0.003;P=0.0008, resp.).Conclusion. mpMRI improved clinically significant prostate cancer detection rate compared to STD protocol alone with less tissue sampling and higher Gleason score. Further development in imaging as well as multicentre studies using the START recommendation is needed to elucidate the role of mpMRI targeted biopsy in the management of prostate cancer.


2019 ◽  
pp. 100-108
Author(s):  
A. V. Vasilev ◽  
A. V. Mishchenko ◽  
R. A. Kadyrleev ◽  
A. S. Petrova ◽  
A. K. Nosov ◽  
...  

Purpose. To evaluate the effectiveness of prostate cancer detection with method of cognitive mpMRI/TRUS fusion biopsy using strain sonoelastography.Materials and methods. Cognitive transrectal fusion biopsy of prostate was performed in 32 patients. According to the data of a preliminary conducted mpMRI, 33 foci suspicious of prostate cancer were included (PIRADSv2 = 3–5). Before the biopsy, all patients underwent ultrasound planning using compression sonoelastography.Results. The overall sensitivity was 76% for the targeted biopsy, and 49% for systematic biopsy. The number of biopsy specimens with a clinically significant Gleason grade in the targeted biopsy group was 85% of all columns with cancer specimens, in the systematic biopsy group this number was 68%. On average, the Gleason grade after targeted biopsy was 7.5 ± 0.9, and it was 7.2 ± 0.9 in the columns after systematic biopsy. On average, the percentage of tumor in the columns after targeted biopsy was 72% ± 29% and it was 55% ± 35% in the columns after systematic biopsy. The false positive for mpMRI was 15%. The overall sensitivity for the strain sonoelastography was 69% in this study, clinically significant cancer was detected in 71% of all columns with cancer specimens. False positive for elastography was observed in 18% of cases.Conclusion. Comparing with systematic biopsy, cognitive mpMRI / TRUS fusion biopsy can improve the detection rate of clinically significant prostate cancer and reduce the number of detected cases of clinically insignificant cancer. In cases of a total or subtotal tumor lesion in the peripheral zone detected on mpMRI, it is possible to take fewer columns for morphological verification of the tumor. The use of compression sonoelastography as an additional parameter of navigation in cognitive mpMRI/TRUS fusion biopsy can be considered as a promising way to increase the detection rate of clinically significant prostate cancer.


Author(s):  
Philipp Dahm

This chapter provides a summary of the landmark PRECISION trial, which investigated how magnetic resonance imaging (MRI) with or without targeted biopsy compared to standard transrectal ultrasonography-guided biopsy in detecting clinically significant prostate cancer. The study provided high-quality evidence to support the use of multiparametric MRI in men with an elevated prostate-specific antigen level as a triage test to help determine the need for a biopsy.


BMC Urology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Lei Wang ◽  
Xiaofei Wang ◽  
Wenfeng Zhao ◽  
Zichen Zhao ◽  
Zhihu Li ◽  
...  

Abstract Background To report a new standardized cognitive fusion technique on transperineal targeted biopsy (TB) of prostate, and to evaluate its efficacy for cancer detection combined with systematic biopsy (SB) . Methods We present a retrospective review of consecutive patients undergoing multiparametric magnetic resonance (mpMRI) imaging of the prostate with subsequent transperineal prostate biopsy from January 2016 to December 2018. A free-hand 12-core SB was performed for each patient. PI-RADS 3–5 lesions were further targeted for biopsy with our TB technique. Firstly, a central point of suspicious lesion (B′) was registered cognitively on a transverse section of transrectal ultrasound (TRUS). Then, biopsy gun punctured vertically through a fixed pioneer site (A) on skin of perineum, and deep into the TRUS section to get A’. Next, targeted site (B), the surface-projection of B′, would be determined on skin of perineum by A and distance from B′ to A’. Finally, puncture through B to reach B′. Pathological findings of SB and TB were analyzed. Results A total of 126 patients underwent transperineal prostate biopsy (47 SB only, 79 SB + TB). The age of the patients was 68.7 ± 9.2 years. The median preoperative PSA value was 11.8 ng/mL. Preoperative prostate volume was 60.5 ± 50.0 mL. The numbers of patients with PI-RADS scores of 1 through 5 were 4, 43, 27, 21 and 31, respectively. The overall detection rate of cancer was 61/126 (48.4%), and it was significantly higher in the combination cohort (56/79, 70.9%) compared with the SB only cohort (5/47, 10.6%, p<0.001). When focused on the combination cohort, TB detected a similar overall rate of PCa (53/79, 67.1% vs 52/79, 65.8%; p = 0.87) compared with SB. The clinically significant PCa (csPC) detection rate was 52/79 (65.8%), while for TB and SB the csPC/PC rate was 51/53 (96.2%) and 48/52 (92.3%), respectively(p = 0.44). TB demonstrated a better sampling performance (positive rate for each core) compared with SB (51.0% vs 31.3%, p < 0.001). Conclusions Surface-projection-based transperineal cognitive fusion targeted biopsy of the prostate has a good efficacy in detecting PCa.


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.


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