Negative Systematic Biopsy Research Articles

MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY?

You have accessJournal of UrologyCME1 Apr 2023MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY? Omri Schwarztuch Gildor, Anna Itshak, Yarden Fleischer, Ilan Leibovitch, Itay Sagy, and Itay Sternberg Omri Schwarztuch GildorOmri Schwarztuch Gildor More articles by this author , Anna ItshakAnna Itshak More articles by this author , Yarden FleischerYarden Fleischer More articles by this author , Ilan LeibovitchIlan Leibovitch More articles by this author , Itay SagyItay Sagy More articles by this author , and Itay SternbergItay Sternberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients with low-risk prostate cancer who are considering active surveillance (AS), it is common to repeat a biopsy within a year of diagnosis, as a confirmatory biopsy. The necessity of this biopsy was tested in the era before diagnosis based on MRI and showed a risk of 25-35% for reclassification in the confirmatory biopsy. Currently, most biopsies and new diagnoses of patients with a tumor suitable for AS are performed under the guidance of MRI. Our goal is to check the chance of reclassification when the diagnosis was made with an MRI-guided biopsy. METHODS: A retrospective review of all confirmatory biopsies performed at our center between 2015-2021. Data were collected about the diagnostic biopsy and the confirming biopsy based on the medical sheet and the pathological report. RESULTS: Of the 114 patients who underwent a confirmatory biopsy during the study period, 75 (65.8%) were diagnosed with a TRUS biopsy (group 1) and 39 (34.2%) with an MRI-guided biopsy (group 2). Patient age, PSA level, prostate size, PSA-D, and MRI findings were similar between groups. All confirmatory biopsies were performed with MRI guidance and included also systematic sampling. Reclassification to grade group (GG) ≥ 2 in the confirming biopsy was found in 31/75 (41.3%) and 15/39 (38.5%) patients in groups 1 and 2, respectively. This difference is not statistically significant (p=0.77). Similar reclassification rate (3/8, 37.5%) occurred in a subgroup (of group 2) of patients with previous negative systematic biopsy. In 9/75 (12.0%) and 4/39 (10.3%) patients in groups 1 and 2, respectively, the MRI-guided samples were found without significant prostate cancer and reclassification was made only because of the systematic samples. CONCLUSIONS: The risk of reclassification in a confirmatory biopsy continues to be significant even in the era of MRI-guided diagnosis of prostate cancer. We emphasize the importance of continuing to perform confirmatory biopsies and ensuring systematic sampling alongside sampling the region of interest. Source of Funding: Self funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e526 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Omri Schwarztuch Gildor More articles by this author Anna Itshak More articles by this author Yarden Fleischer More articles by this author Ilan Leibovitch More articles by this author Itay Sagy More articles by this author Itay Sternberg More articles by this author Expand All Advertisement PDF downloadLoading ...

Routine systematic prostate biopsies not replaced by magnetic resonance imaging-targeted biopsy.

Multiparametric magnetic resonance imaging improves the performance of prostate cancer (PCa) diagnostics through a better selection of patients. The aim of the study was to study the detection rate (DR) of systematic and targeted cognitive biopsies in a cohort with the previous negative systematic biopsies. A secondary objective was to describe the value of prostate-specific antigen density (PSAd) in the detection of clinically significant PCa (CSPCa). We designed a prospective, single-center, and comparative study to determine the DR of systematic and targeted cognitive biopsies. The clinical and pathological characteristics of each patient were described. A total of 111 patients with Prostate Imaging Reporting and Data System lesions > 3 were included in the study. PCa was detected in 41.4% (46 of 111 patients); 42 (91.3%) were detected by systematic biopsy and 30 (65.2%) by targeted biopsy. CSPCa was detected in 26 (23.4%), 23 (88.5%) by systematic biopsy, and 21 (76.9%) by targeted biopsy. PSAd > 0.15 was directly associated with CSPCa. The detection of PCa by systematic biopsy in this series was higher than 80%; hence, its routine use should not be replaced by targeted biopsy, since it continues to be the cornerstone of the diagnosis in patients with prior negative biopsies.

50 - mpMRI and transrectal ultrasound fusion biopsy in prostate cancer detection in men with previous negative systematic biopsy: A single-center five years’ outcomes.

50 - mpMRI and transrectal ultrasound fusion biopsy in prostate cancer detection in men with previous negative systematic biopsy: A single-center five years’ outcomes.

PD11-11 A URINARY EXOSOME ASSAY INTERROGATING SMALL NON-CODING RNAS ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW- INTERMEDIATE- OR HIGH-RISK DISEASE

You have accessJournal of UrologyCME1 May 2022PD11-11 A URINARY EXOSOME ASSAY INTERROGATING SMALL NON-CODING RNAS ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW- INTERMEDIATE- OR HIGH-RISK DISEASE Laurence Klotz, Winnie Wang, Alvin Lopez Pujals, Deepak Kapoor, Rebecca DeVaux, Greg DiRienzo, Federico Corica, Ann Anderson, Carl Olsson, Alberto Corica, James Libby, and Martin Tenniswood Laurence KlotzLaurence Klotz More articles by this author , Winnie WangWinnie Wang More articles by this author , Alvin Lopez PujalsAlvin Lopez Pujals More articles by this author , Deepak KapoorDeepak Kapoor More articles by this author , Rebecca DeVauxRebecca DeVaux More articles by this author , Greg DiRienzoGreg DiRienzo More articles by this author , Federico CoricaFederico Corica More articles by this author , Ann AndersonAnn Anderson More articles by this author , Carl OlssonCarl Olsson More articles by this author , Alberto CoricaAlberto Corica More articles by this author , James LibbyJames Libby More articles by this author , and Martin TenniswoodMartin Tenniswood More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002537.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The miR Sentinel® Test measures the expression of 442 small non-coding RNAs (sncRNAs) extracted from urinary exosomes to differentiate patients with No Molecular Evidence of Prostate Cancer (NMEPCa) from those with Molecular Evidence of Prostate Cancer (MEPCa). The test further classifies men with MEPCa into low-, intermediate- or high-risk disease. We compared the results of the miR Sentinel® PCC4 Test to systematic and MRI-guided core needle biopsy in men at risk for prostate cancer. METHODS: 763 biopsy naïve men in whom a prostate biopsy was indicated, were recruited. sncRNAs were isolated from urinary exosomes and interrogated by RT-qPCR on a custom designed OpenArray platform. RESULTS: The validation cohort consisted of 763 biopsy naïve patients undergoing systematic or systematic plus targeted biopsy. The molecular classification was compared to the Gleason Grade Group (GG) (Table 1). Sensitivity for the classification of {NPEPC or GG1} versus {GG2-5} was 75+18+4+105=203)/221=92.2% and the negative predictive value for absence of CS PCa was (221+64+12+123=420)/(238+200=420)= 96%. The apparent false positive rate for CS cancer was (34+35+32+22=(123)/(543) = 23%. 208 of the patients had discordant systematic and targeted biopsies. 29 of these had a negative systematic biopsy and a positive targeted biopsy. The molecular test predicted the targeted biopsy outcome in 27/29=93.1% overall, and in 14/15 (93%) of the cases with clinically significant cancer. In the 18 patients with positive systematic and negative MRI targeted biopsies, the test result predicted the positive biopsy in 100%. CONCLUSIONS: The miR Sentinel Test offers an accurate non-invasive means to accurately identify the presence or absence of prostate cancer and classify risk status predict pathological grade on biopsy. The high predictive accuracy of the test in patients whose systematic and targeted biopsy were discordant suggests that the 23% discordance between negative biopsy results and positive Sentinel Test results was in most cases due to false negative biopsies. Source of Funding: The study was funded by miR Scientific © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e194 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence Klotz More articles by this author Winnie Wang More articles by this author Alvin Lopez Pujals More articles by this author Deepak Kapoor More articles by this author Rebecca DeVaux More articles by this author Greg DiRienzo More articles by this author Federico Corica More articles by this author Ann Anderson More articles by this author Carl Olsson More articles by this author Alberto Corica More articles by this author James Libby More articles by this author Martin Tenniswood More articles by this author Expand All Advertisement PDF DownloadLoading ...

This Month in Adult Urology

This Month in Adult Urology

Predictors of disparity between targeted and in-zone systematic cores during transrectal MR/US-fusion prostate biopsy.

The combination of targeted and systematic biopsies during MR/US-fusion prostate biopsy improves cancer detection over either modality alone. To identify factors associated with disparity in detection of prostate cancer between systematic and targeted biopsies in magnetic resonance imaging positive zones. We retrospectively analyzed 171 men receiving initial MR/US fusion biopsy at our institution from 2015 to 2018. Disparity was defined as positive targeted but negative systematic biopsy within an magnetic resonance imaging-positive zone (PIRADS 3+), or vice versa. Multivariable logistic regression was used to identify factors associated with disparity in detection of cancer on a per lesion basis. Three hundred and fifty-five lesions were targeted. For any cancer and clinically significant prostate cancer (csPCa), 37 (10%) and 24 (7%) lesions were target positive/systematic negative, respectively, while 30 (8%) and 23 (6%) lesions were target negative/systematic positive. In multivariable analysis, anterior location (OR 4.1, 95% CI 1.5-11.4, P = 0.007) was associated with csPCa target positive/systematic negative disparity, while higher prostate volume (OR 1.14, 95% CI 1.0-1.29, P = 0.04) was associated with csPCa target negative/systematic positive disparity. Shorter distance from apex (OR 1.02, 95% CI 1.01-1.04, P = 0.02) was associated with target positive/systematic negative disparity for any cancer. Limitations included relatively limited sample size and lack of prostatectomy specimen as a gold standard. Anterior or apical lesion location favors better disease capture on targeted biopsies. When doing systematic-only biopsies, surgeons may consider sampling the anterior zone separately.

MP26-06 EFFECTS OF MAGNETIC RESONANCE IMAGING TARGETING ON OVERDIAGNOSIS AND OVERTREATMENT OF PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Detection & Screening II (MP26)1 Sep 2021MP26-06 EFFECTS OF MAGNETIC RESONANCE IMAGING TARGETING ON OVERDIAGNOSIS AND OVERTREATMENT OF PROSTATE CANCER Andrew Vickers Andrew VickersAndrew Vickers More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002023.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: It has been suggested that targeting prostate lesions identified on magnetic resonance imaging (MRI) will improve the sensitivity of prostate biopsy for high-grade disease. The clinical significance of high-grade tumors found by MRI-targeting in men with benign systematic biopsy findings is open to question. We compared data from the National Cancer Institute (NCI) study of MRI-targeted biopsy with results from long-term follow-up of men who had negative sextant biopsy in the European Randomized trial of Screening for Prostate Cancer (ERSPC) METHODS: The NCI study included finding from MRI-targeted biopsy for 999 men with negative systematic biopsy. For ERSPC, 3,056 men who had negative sextant biopsy were followed for 11 years. We calculated the number of patients needing to be diagnosed (NND) and treated (NNT) following targeted biopsy in order to prevent one prostate cancer death at 11 years. We used a simple modelling approach that involved several assumptions, such as the proportion of the deaths in the ERSPC would have been prevented by earlier diagnosis had the initial biopsy been MRI-guided. We then varied these assumptions to assess the effects on the results. RESULTS: In the base scenario, which involved assumptions favorable to MRI, NND and NNT were 89 and 57 (table). Results were only more encouraging for MRI-targeting under unlikely scenarios, such as 100% sensitivity for MRI and 100% cure rates for treatment. CONCLUSIONS: Although MRI may be of benefit overall, considering decreases in overdiagnosis resulting from avoidance of biopsy in men with negative scans, targeting biopsy needles to MRI-detected lesions results in a large number of men diagnosed and treated per death prevented. Consideration should be given to changing guidelines on grading of MRI cores and those regarding treatment of high-grade prostate cancer. Source of Funding: This work was supported in part by the National Institutes of Health/National Cancer Institute (NIH/NCI) with a Cancer Center Support Grant to Memorial Sloan Kettering Cancer Center [P30 CA008748], a SPORE grant in Prostate Cancer to Dr. H. Scher [P50-CA92629], the Sidney Kimmel Center for Prostate and Urologic Cancers and David H. Koch through the Prostate Cancer Foundation. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e464-e464 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrew Vickers More articles by this author Expand All Advertisement Loading ...

PD17-10 THE SIGNIFICANCE OF MULTIPLE NEGATIVE BIOPSIES IN PATIENTS ON ACTIVE SURVEILLANCE

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance I (PD17)1 Sep 2021PD17-10 THE SIGNIFICANCE OF MULTIPLE NEGATIVE BIOPSIES IN PATIENTS ON ACTIVE SURVEILLANCE Nabila Khondakar, Jillian Egan, Luke O'Connor, Michael Ahdoot, Cheyenne Williams, Michael Daneshvar, Nitin Yerram, Jeunice Owens-Walton, Patrick Gomella, Sandeep Gurram, Peter Choyke, Maria Merino, Bradford Wood, Baris Turkbey, and Peter Pinto Nabila KhondakarNabila Khondakar More articles by this author , Jillian EganJillian Egan More articles by this author , Luke O'ConnorLuke O'Connor More articles by this author , Michael AhdootMichael Ahdoot More articles by this author , Cheyenne WilliamsCheyenne Williams More articles by this author , Michael DaneshvarMichael Daneshvar More articles by this author , Nitin YerramNitin Yerram More articles by this author , Jeunice Owens-WaltonJeunice Owens-Walton More articles by this author , Patrick GomellaPatrick Gomella More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , Peter ChoykePeter Choyke More articles by this author , Maria MerinoMaria Merino More articles by this author , Bradford WoodBradford Wood More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001999.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Low-risk prostate cancer patients receive multiple biopsies over the course of active surveillance (AS). MRI enables earlier detection of disease and may help to risk-stratify patients. We aimed to assess the significance of multiple negative biopsies in AS patients who received MRI per our AS protocol. We also compared disease progression in patients who had multiple combined MRI-targeted and 12-core systematic biopsies (combined biopsy), versus multiple systematic biopsies alone. METHODS: We queried our database of patients referred for possible AS between 2007 and 2020, and who had confirmatory biopsy. Patients with at least three total biopsies (diagnostic, confirmatory, and follow-up) and Gleason Grade ≤2 on confirmatory biopsy were included. Negative biopsy was defined as no cancer on any biopsy cores. Kaplan-Meier survival analysis was used to assess time to progression. Analyses were repeated in subgroups who received combined vs. systematic biopsy. RESULTS: A total of 219 patients met inclusion criteria. Median age at confirmatory biopsy was 62 years. Distribution of biopsy results was as follows: 107 patients (48.9%) had zero negative biopsies, 49 (22.3%) had consecutive negative biopsies, 51 (23.3%) had only one negative biopsy, and 11 (5.0%) had non-consecutive negative biopsies. Having multiple negative biopsies was associated with longer progression free survival (PFS) (log-rank p<0.0001). When stratified by biopsy type, multiple negative combined biopsies were associated with longer PFS (p<0.0001) whereas multiple negative systematic biopsies were not (p=0.34). Median time to progression was 3.1 years with zero negative biopsies, 6.5 years with one negative biopsy, 7.7 years with consecutive negative biopsies, and 8.3 years with non-consecutive negative biopsies. CONCLUSIONS: In an AS cohort of patients with GG ≤2 at time of confirmatory biopsy, having at least one negative biopsy was associated with PFS time more than double that of patients with no negative biopsies. Our findings suggest that patients with multiple negative prostate biopsies do not require frequent surveillance biopsies that traditionally have been offered to AS patients. Source of Funding: NIH Intramural Funding, NIH Medical Research Scholars Program, Foundation for the NIH © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e288-e288 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nabila Khondakar More articles by this author Jillian Egan More articles by this author Luke O'Connor More articles by this author Michael Ahdoot More articles by this author Cheyenne Williams More articles by this author Michael Daneshvar More articles by this author Nitin Yerram More articles by this author Jeunice Owens-Walton More articles by this author Patrick Gomella More articles by this author Sandeep Gurram More articles by this author Peter Choyke More articles by this author Maria Merino More articles by this author Bradford Wood More articles by this author Baris Turkbey More articles by this author Peter Pinto More articles by this author Expand All Advertisement Loading ...

Usefulness of Prostate-Specific Antigen Density as an Indicator for Recommending Prebiopsy Magnetic Resonance Imaging to Prevent Missed Prostate Cancer Diagnoses

Purpose: To identify the indication for recommending prebiopsy magnetic resonance imaging (MRI) to prevent prostate cancer missed diagnoses in cases without prebiopsy MRI.Materials and Methods: Between January 2017 and September 2020, 585 patients suspected with prostate cancer underwent prostate biopsy after MRI. For patients with visible lesions, MRI-targeted biopsy using an image-based fusion program was performed in addition to the 12- core systematic biopsy. Patients for whom MRI was performed in other institutions (n=4) and patients who underwent target biopsy alone (n=7) were excluded.Results: Of 574 patients (median prostate-specific antigen [PSA] level, 6.88 ng/mL; mean age, 68.2 years), 342 (59.6%) were diagnosed with prostate cancer (visible lesions=312/449 [69.5%]; nonvisible lesions=30/123 [24.0%]). The detection rates of visible lesions stratified using the Prostate Imaging Reporting and Data System score (3 vs. 4 vs. 5) were 30.9% (54 of 175), 61.2% (150 of 245), and 90.1% (127 of 141), respectively. Multivariate analysis showed that PSA density was a significant factor for presence of visible lesions, prostate cancer, and significant prostate cancer diagnosis. Among patients with positive lesions, 27 (8.2%) were diagnosed with prostate cancer concomitant with negative systematic biopsy results. A PSA density of 0.15 ng/mL/cm&lt;sup&gt;3&lt;/sup&gt; was identified as the significant cutoff value for predicting positive target biopsy in groups with negative systematic biopsy. Sixty of the negative target lesions (26.1%) were diagnosed using systematic biopsy.Conclusions: To maximize cancer detection rates, both targeted and systematic biopsies should be implemented. PSA density was identified as a useful factor for recommending prebiopsy MRI to patients suspected with prostate cancer.

External validation of a prostate cancer nomogram on magnetic resonance/transrectal ultrasound fusion biopsy in men with prior negative systematic biopsy.

To observe how the nomogram, which was created by Truong et al, works in an independent patient group by performing external validation. One hundred and eighty-one patients who had at least one prior negative 12-core standard systematic biopsy and lesions with PI-RADS scores of 3 or higher that were detected as a result of mpMRI were included in the study. Targeted biopsy with 12-core standard systematic biopsy was performed on all patients. Clinical and pathological features of the patients were recorded. The discrimination, calibration and decision curve analysis were performed to externally validate the nomogram. A total of 181 patients with previous negative 12-core systematic biopsies were analysed. One hundred and thirty-four patients (74%) had benign pathology. Radiological volume and PI-RADS scores of 4 and 5 were found as independent predictors of benign pathology. The area under the curve (CI 95%) was found to be 0.80 (0.73-0.87), indicating good discrimination. The median residual was calculated as -0.0873, the intercept as -0.0690, the slope as 0.8927 and r2 as 0.2586, indicating good calibration. The standardised net benefit of follow-up decisions was found to be 0.54 and 0.36 at the probability threshold of 0.7 and 0.8, respectively. The original model showed good discrimination and calibration with our data. Defining a high probability threshold for clinical use would be appropriate for centres with high benign biopsy rates similar to our centre.

Effects of Magnetic Resonance Imaging Targeting on Overdiagnosis and Overtreatment of Prostate Cancer

BackgroundIt has been suggested that targeting prostate lesions identified on magnetic resonance imaging (MRI) will improve the sensitivity of prostate biopsy for high-grade disease. The clinical significance of high-grade tumors found on MRI but missed on systematic biopsy is open to question. ObjectiveTo determine the risk of mortality for high-grade cancers identified by MRI targeting in men who had benign systematic biopsy findings. Design, setting, and participantsWe used data from 999 men with negative systematic biopsy and concurrent MRI-targeted biopsy in the National Cancer Institute MRI study. The comparison group consisted of 3056 men followed for 11 yr after negative sextant biopsy in the European Randomized Trial of Screening for Prostate Cancer (ERSPC). Outcome measurements and statistical analysisWe calculated the number of patients needed to be diagnosed (NND) and treated (NNT) following targeted biopsy in order to prevent one prostate cancer death at 11 yr. We used a simple modeling approach that involved several assumptions, such as the proportion of the deaths in ERSPC preventable by earlier detection with MRI-guided biopsy. We then varied these assumptions to assess the effects on the results. Results and limitationsNND and NNT were 89 and 57 for the scenario involving assumptions favorable to MRI, and 169 and 127 for a more neutral set of assumptions, respectively. Results were only more encouraging for MRI targeting under unlikely scenarios, such as 100% sensitivity for MRI and a cure rate of 100% for treatment. ConclusionsAlthough MRI may be of benefit overall, considering the decrease in overdiagnosis among men with negative MRI findings, targeting biopsy needles to MRI-detected lesions results in a large number of men diagnosed and treated per death prevented. Consideration should be given to changing guidelines on grading of MRI cores and those regarding treatment of MRI-detected high-grade prostate cancer. Patient summaryWe carried out a modeling study to assess how magnetic resonance imaging (MRI) scan results used to target prostate cancer lesions during biopsy can affect outcomes. The model results show that if MRI-visible tumors are targeted during prostate biopsy, a large number of men need to be diagnosed and treated for prostate cancer in order to avoid just one prostate cancer death.

Detection of clinically significant prostate cancer with 18F-DCFPyL PET/multiparametric MR

To assess whether 18F-DCFPyL PET/multiparametric (mp)MR contributes to the diagnosis of clinically significant (cs) prostate cancer (PCa) compared to mpMR in patients with suspicion of PCa, or patients being considered for focal ablative therapies (FT). This ethics review board-approved, prospective study included 55 men with suspicion of PCa and negative systematic biopsies or clinically discordant low-risk PCa (n = 21) or those being considered for FT (n = 34) who received 18F-DCFPyL PET/mpMR. Each modality, PET, mpMR, and PET/MR (using the PROMISE classification), was assessed independently. All suspicious lesions underwent PET/MR-ultrasound fusion biopsies. There were 45/55 patients (81.8%) that had histologically proven PCa and 41/55 (74.5%) were diagnosed with csPCa. Overall, 61/114 lesions (53.5%) identified on any modality were malignant; 49/61 lesions (80.3%) were csPCa. On lesion-level analysis, for detection of csPCa, the sensitivity of PET was higher than that of mpMR and PET/MR (86% vs 67% and 69% [p = 0.027 and 0.041, respectively]), but at a lower specificity (32% vs 85% and 86%, respectively [p < 0.001]). The performance of MR and PET/MR was comparable. For identification of csPCa in PI-RADS ≥ 3 lesions, the AUC (95% CI) for PET, mpMR, and PET/MR was 0.75 (0.65-0.86), 0.69 (0.56-0.82), and 0.78 (0.67-0.89), respectively. The AUC for PET/MR was significantly larger than that of mpMR (p = 0.04). PSMA PET detects more csPCa than mpMR, but at low specificity. The performance PET/MR is better than mpMR for detection of csPCa in PI-RADS ≥ 3 lesions. NCT03149861.

Optimal Number of Systematic Biopsy Cores Used in Magnetic Resonance Imaging/Transrectal Ultrasound Fusion Targeted Prostate Biopsy

In recent years, the effectiveness of magnetic resonance imaging (MRI)-ultrasound fusion targeted biopsy (MRF-TB) has been widely reported. In this study, we assessed the effect of reduction of the number of systematic biopsy (SB) cores on the cancer detection rate (CDR). Patients with a high prostate-specific antigen (PSA) level underwent prostate MRI. The Prostate Imaging-Reporting and Data System version 2 (PI-RADS) was then used to rate the lesions. The inclusion criteria were as follows: (1) PSA level between 4.0 and 30.0 ng/mL and (2) patients with one or more lesions on MRI and a PI-RADS score of 3 or more. All enrolled patients were SB naïve or had a history of one or more prior negative SBs. A total of 104 Japanese met this selection criterion. We have traditionally performed 14-core SB following the MRF-TB. In this study, the CDRs of 10-core SB methods, excluding biopsy results at the center of the base and mid-level on both sides, were compared with those of the conventional biopsy method. We compared CDRs of the 14-core and 10-core SBs used in combination. The overall CDR was 55.8% for the former and 55.8% for the latter, thereby indicating that there was no significant difference (P = 1.00) between the two. In addition, the CDRs of csPCa were 51.9% for the former and 51.1% for the latter, which indicated that there was no significant difference (P = 0.317). There was no significant difference in the CDR when the number of SB cores to be used in combination was 14 and 10.

What is the risk of prostate cancer mortality following negative systematic TRUS-guided biopsies? A systematic review

ObjectiveTo investigate the risk of prostate cancer-specific mortality (PCSM) following initial negative systematic transrectal ultrasound-guided (TRUS) prostate biopsies.DesignSystematic review.Data sourcesPubMed and Embase were searched using a string combination with keywords/Medical...

MRI/TRUS fusion vs. systematic biopsy: intra-patient comparison of diagnostic accuracy for prostate cancer using PI-RADS v2.

To evaluate the efficacy of multiparametric magnetic resonance/transrectal ultrasound fusion (MRI/TRUS fusion) biopsy versus systematic biopsy and its association with PI-RADS v2 categories in patients with suspected prostate cancer. 122 patients undergoing both MRI/TRUS fusion and systematic biopsy, with suspicion of prostate cancer, with suspicious findings on MRI based on PI-RADS v2, were included between April 2016 and March 2017. Comparison of tumor detection rates using each technique and combined techniques was performed for all lesions as well as those that are traditionally difficult to access (i.e., anterior lesions). Prostate cancer was detected in 83/122 patients (68%) with 74.6% clinically significant lesions (Gleason 3 + 4 or greater). There was a statistically significant difference in presence of clinically significant prostate cancer in PI-RADS v2 categories of 3, 4, and 5 (20%, 52% and 77%, respectively, p < 0.001). Fusion biopsy was positive in a significantly higher percentage of patients versus systematic biopsy (56% versus 48%, respectively, p < 0.05). The fusion biopsy alone was positive in 20%. Of 34 patients with anterior lesions on MRI, 44% were detected only by fusion biopsy, with a joint yield of 71%. In patients with previous negative systematic biopsies, 48.7% lesions were found by fusion biopsy with 20.5% being exclusively positive by this method. The percentage of positive cores for fusion biopsies was significantly higher than for systematic biopsies (26% vs. 12.3%, p < 0.001). The incorporation of MRI/TRUS fusion biopsy significantly improves the detection rate of prostate cancer versus systematic biopsy, particularly for anterior lesions.

Detection of clinically significant prostate cancer after negative fusion and systematic biopsy.

288 Background: MRI/Ultrasound fusion biopsy of the prostate has enhanced the detection of clinically significant prostate cancer (csPCa). Detection of csPCa is greatest when fusion and systematic biopsies are combined. However, the finding of a negative fusion and negative systematic biopsy in patients with suspicious lesion on imaging raises the question of either falsely positive imaging or a false negative biopsy. Methods: We retrospectively reviewed our database of patients undergoing MRI/transrectal US-guided fusion biopsy. All images were graded according to the Prostate Imaging Reporting and Data System version (PIRADS) 2.0. Patients underwent targeted biopsy followed by systematic 12-core double sextant biopsy within the same session. csPCa was defined as Grade Group (GG) ≥2 PCa. Patients with no prostate cancer (PCa) found on biopsies were followed. MRI studies with PIRADS v2 score ≤ 2 were considered to have no MRI evidence of PCa. Results: A total of 400 patients had at least one PIRADS ≥3 lesion and underwent fusion/systematic biopsy. Of these, 113 (28.3%) patients had no evidence of PCa on either fusion or systematic biopsy. Median follow-up was 32.5 months. 44 (39%) patients underwent repeat MRI and of these, 24 (54%) had no evidence of PCa on repeat MRI. PIRADS lesion disappearance was associated with lower PSA Density (PSAd) (0.12 vs 0.20; P = 0.0319) and decreased progression to repeat biopsy (8.33% vs 95%; P &lt; 0.0001). Patients who had a repeat biopsy had a greater PSAd ( 0.21 vs 0.12; P = 0.0054). Of 113 patients with negative initial biopsy, 23 (20.4 %) underwent repeat biopsy: 16 (14.2 %) had PCa and 11 (9.7%) had csPCa. Thus, 48% of patients who underwent repeat biopsy had csPCa. Among patients with a PCa on repeat biopsy, cancer was sampled by MRI targeted cores in 80% of patients. Conclusions: Despite a negative initial fusion/systematic biopsy, at least 10% of patients were subsequently diagnosed with clinically significant PCa. The combination of elevated PSAd and the persistence of a suspicious lesion on repeat MRI appears selective for previously missed PCa. However, after negative fusion biopsy, repeat MRI yields a high rate of PIRADS lesion disappearance in patients with low PSAd.

Targeted prostate biopsy using a cognitive fusion of multiparametric magnetic resonance imaging and transrectal ultrasound in patients with previously negative systematic biopsies and non-suspicious digital rectal exam

AimTo compare cognitive fusion targeted and systematic prostate biopsy in patients with repeated negative systematic biopsy but persistent clinical suspicion for prostate cancer.MethodsThe study enrolled 63 patients with at least one previously negative systematic biopsy who underwent targeted prostate biopsy using multiparametric magnetic resonance imaging (mpMRI) and transrectal ultrasound (TRUS) in addition to standardized systematic biopsy from July 2016 to May 2018. Multiparametric MRI was performed with 3 Tesla device by uro-radiologists experienced in prostate cancer. Lesions with Prostate Imaging Reporting and Data System 3, 4, and 5 were considered suspicious. Targeted biopsies were performed with cognitive fusion of TRUS and mpMRI.ResultsProstate cancer detection, using either targeted or systematic biopsy, was 60.32%. Targeted biopsies were positive in 52.38% and systematic biopsies in 47.62% of patients. The median highest percentage of cancer involvement per biopsy core was significantly higher in targeted cylinders. The biopsies obtained by using the two techniques did not significantly differ in Gleason score.ConclusionCognitive targeted prostate biopsy based on mpMRI presents a valuable addition to systematic biopsy in patients with repeated negative systematic biopsies but persistent clinical suspicion of prostate cancer.

Prostate MRI-TRUS fusion biopsy: a review of the state of the art procedure.

Prostate cancer is the fourth most common cancer and population-based screening programmes are being increasingly adopted worldwide. Screening-positive patients undergo routine transrectal ultrasound (TRUS)-guided systematic biopsy, which is the current diagnostic standard for prostate cancer. However, systematic biopsies suffer from poor sensitivity, especially for the tumors of the anterior prostate and apex as well as in large volume glands. In the past decade, MRI-guided targeted biopsies have come up, which utilize the multiparametric capability of MRI to target lesions for sampling. MRI/TRUS fusion biopsies combine the advantages of MRI-targeting with that of real-time guidance made possible by TRUS. MRI-TRUS fusion biopsies are being increasingly used in men with high clinical suspicion of prostate cancer who have had prior negative systematic biopsies. A large number of fusion biopsy platforms are currently available commercially. Although the basic workflow is similar, there are differences in the operational software, biopsy routes offered, TRUS acquisition technique, type of correction applied at the time of fusion and in the probe tracking hardware. The article describes the current role and indications of MRI-TRUS fusion biopsy followed by a discussion on the workflow, patient preparation, biopsy procedure and complications.

MRI-Targeted Prostate Biopsy: What Radiologists Should Know.

Transrectal ultrasound (TRUS)-guided systematic biopsy, the current gold standard for the detection of prostate cancer, suffers from low sensitivity for clinically significant cancer. The use of diagnostic multiparametric MRI has increased the relevance of targeted biopsy techniques such as MRI-TRUS fusion biopsy and direct (in-bore) MRI-guided biopsy, which have higher detection rate for clinically significant cancer. Although primarily used in patients who remain at high clinical suspicion for prostate cancer despite a negative systematic biopsy, with the increasing use of upfront diagnostic MRI, these biopsies are expected to replace routine systematic biopsies. This pictorial essay aims to enhance our understanding of the concepts of these biopsy techniques so that they can be performed safely and provide maximum diagnostic yield.

Complications and Adverse Events of Three Magnetic Resonance Imaging–based Target Biopsy Techniques in the Diagnosis of Prostate Cancer Among Men with Prior Negative Biopsies: Results from the FUTURE Trial, a Multicentre Randomised Controlled Trial

BackgroundThree techniques of magnetic resonance imaging (MRI)-based targeted biopsy (TB) of the prostate exist. There is no superiority regarding diagnostic efficacy of prostate cancer (PCa) detection. ObjectiveTo compare adverse events (AEs) among three TB techniques and to evaluate the effect on urinary and erectile function. Design, setting, and participantsPost hoc analysis of a multicentre randomised controlled trial among men with negative systematic biopsy (SB) and suspicion of PCa. InterventionIn 234 patients, 3-T multiparametric MRI demonstrated PIRADS≥ 3 lesions, and patients were randomised 1:1:1 for TB: transrectal in-bore MRI TB (MRI-TB), transperineal MRI-transrectal ultrasound (TRUS) fusion TB (FUS-TB), and transrectal cognitive TRUS TB (COG-TB). Outcome measurements and statistical analysisAEs (Clavien-Dindo) were compared using Pearson chi-square test. Univariate logistic regression tests were performed for the number of cores, biopsy approach, and usage of anticoagulants. The participants filled in baseline and 30-d postbiopsy International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The delta between measurements was compared using one-way analysis of variance. Results and limitationsThere were significant differences in minor AEs: 53% in MRI-TB, 71% in FUS-TB, and 85% in COG-TB (p < 0.001). The number of cores was associated with AEs (odds ratio [OR] 1.11 per extra biopsy [95% confidence interval {CI} 1.06–1.17, p < 0.001]). Anticoagulants were not associated with bleeding complications (OR 1.24 [95% CI 0.66–2.35, p = 0.5]). Transrectal approach (MRI-TB + COG-TB) increased the risk of any AE (OR 2.54 [95% CI 1.16–5.77, p < 0.05]) and nonsignificantly increased the risk of urinary tract infections (OR 3.69 [95% CI 0.46–168.4, p = 0.3]). Biopsy did not impact urinary (ΔIPSS 0.3, p = 0.1) and erectile function (ΔIIEF-5 –0.4, p = 0.5). The main limitation was that additional SB was performed in FUS-TB and COG-TB, and was omitted in MRI-TB, making comparison difficult. ConclusionsThere was a significant difference in minor AEs among groups. An increase in the number of cores increased the overall risk of AEs. A low AE occurrence in MRI-TB was likely caused by the omission of SB. Prostate biopsy did not impact self-reported urinary and erectile functions. Patient summaryIn this study, we compared the complication rates of three techniques of magnetic resonance imaging (MRI)-based targeted biopsy of the prostate. We found a significant difference in the occurrence of minor complication rates among three groups in favour of transrectal in-bore MRI targeted biopsy, likely caused by the omission of additional systematic biopsy in this group.