Negative mpMRI Research Articles

Negative multiparametric magnetic resonance imaging for prostate cancer: further outcome and consequences

PurposeEAU guidelines recommend multiparametric MRI of the prostate (mpMRI) prior to biopsy to increase accuracy and reduce biopsies. Whether biopsy can be avoided in case of negative mpMRI remains unclear. Aim of this study is to evaluate predictors of overall prostate cancer (PCa) in negative mpMRI.MethodsA total of 216 patients from 2018 to 2020 with suspicion of PCa and negative mpMRI (PI-RADS ≤ 2) were interviewed by telephone about outcome and further follow-up. Clinically significant PCa (csPCa) was defined as ISUP ≥ 2. Patients with vs. without biopsy and with vs. without PCa were compared. Univariate and multivariate analyses were performed to evaluate predictors of PCa occurrence in patients with negative mpMRI.Results15.7% and 5.1% of patients with PI-RADS ≤ 2 on mpMRI showed PCa and csPCa, respectively. PCa patients had higher PSAD (0.14 vs. 0.09 ng/ml2; p = 0.001) and lower prostate volume (50.5 vs. 74.0 ml; p = 0.003). Patients without biopsy (25%) after MRI were older (69 vs. 65.5 years; p = 0.027), showed lower PSA (5.7 vs. 6.73 ng/ml; p = 0.033) and lower PSA density (0.09 vs. 0.1 ng/ml2; p = 0.027). Multivariate analysis revealed age (OR 1.09 [1.02–1.16]; p = 0.011), prostate volume (OR 0.982 [0.065; 0.997]; p = 0.027), total PSA level (OR 1.22 [1.01–1.47], p = 0.033), free PSA (OR 0.431 [0.177; 0.927]; p = 0.049) and no PI-RADS lesion vs PI-RADS 1–2 lesion (OR 0.38 [0.15–0.91], p = 0.032.) as predictive factors for the endpoint presence of PCa.ConclusionsBiopsy for selected patient groups (higher age, prostate volume and free PSA as well as lower PSA-Density) with negative mpMRI can be avoided, if sufficient follow-up care is guaranteed. Detailed counseling regarding residual risk for undetected prostate cancer should be mandatory.

Evaluation of post-ablation mpMRI as a predictor of residual prostate cancer after focal high intensity focused ultrasound (HIFU) ablation.

To evaluate the performance of multiparametric magnetic resonance imaging (mpMRI) and PSA testing in follow-up after high intensity focused ultrasound (HIFU) focal therapy for localized prostate cancer. A total of 73 men with localized prostate cancer were prospectively enrolled and underwent focal HIFU followed by per-protocol PSA and mpMRI with systematic plus targeted biopsies at 12 months after treatment. We evaluated the association between post-treatment mpMRI and PSA with disease persistence on the post-ablation biopsy. We also assessed post-treatment functional and oncological outcomes. Median age was 69 years (Interquartile Range (IQR): 66-74) and median PSA was 6.9 ng/dL (IQR: 5.3-9.9). Of 19 men with persistent GG ≥ 2 disease, 58% (11 men) had no visible lesions on MRI. In the 14 men with PIRADS 4 or 5 lesions, 7 (50%) had either no cancer or GG 1 cancer at biopsy. Men with false negative mpMRI findings had higher PSA density (0.16 vs. 0.07 ng/mL2, P = 0.01). No change occurred in the mean Sexual Health Inventory for Men (SHIM) survey scores (17.0 at baseline vs. 17.7 post-treatment, P = 0.75) or International Prostate Symptom Score (IPSS) (8.1 at baseline vs. 7.7 at 24 months, P = 0.81) after treatment. Persistent GG ≥ 2 cancer may occur after focal HIFU. mpMRI alone without confirmatory biopsy may be insufficient to rule out residual cancer, especially in patients with higher PSA density. Our study also validates previously published studies demonstrating preservation of urinary and sexual function after HIFU treatment.

SC277 - Assessing the role of high-resolution micro-ultrasound among patients with a negative multiparametric MRI and persistent suspicion of prostate cancer

SC277 - Assessing the role of high-resolution micro-ultrasound among patients with a negative multiparametric MRI and persistent suspicion of prostate cancer

Intermediate-term oncological outcomes after a negative endorectal coil multiparametric MRI of the prostate in patients without biopsy proven prostate cancer

PurposeInvestigate the intermediate-term oncological outcome after negative multiparametric MRI (mpMRI) of the prostate in patients without biopsy proven prostate cancer (PCa). MethodsThe retrospective study included 121 patients with negative mpMRI (Prostate Imaging Reporting and Data System version 2.1 category<3) performed at our institution between 2012 and 2017 without known biopsy proven PCa. Clinical and pathological data were collated including post-MRI prostatic tissue diagnoses with highest Grade Group and most recent prostate specific antigen (PSA) levels up to any definitive prostate cancer treatment. Mean PSA velocities between patients with and without a subsequent diagnosis of Grade Group 2 or higher (GG2+) PCa were compared, and an optimal threshold value was calculated. ResultsOutcome data available included PSA values in 117 patients and prostate tissue sampling in 52 patients. Over a median follow up interval of 49.8 months, only 11 of 121 patients (9.1%) were diagnosed with GG2+ PCa, 10 patients (8.3%) with GG1 PCa, and 31 patients (25.6%) had negative prostate tissue samples. Mean PSA velocity was significantly higher in the patients diagnosed with GG2+ PCa (3.87 ng/mL/year) compared to those not diagnosed with GG2+ PCa (−0.71 ng/mL/year, p < 0.001). A threshold PSA velocity of 0.27 ng/mL/year had a 100% sensitivity and 69.8% specificity for GG2+ PCa (AUC: 0.898). Conclusion<10% of patients with negative mpMRI without prior biopsy proven PCa were diagnosed with GG2+ PCa over median follow up of over four years and were associated with PSA velocity of ≥0.27 ng/mL/year. PSA monitoring may be a reasonable management strategy in patients with a negative mpMRI without biopsy proven PCa.

Magnetic Resonance Imaging–targeted Prostate Biopsy Compared with Systematic Prostate Biopsy in Biopsy-naïve Patients with Suspected Prostate Cancer

BackgroundIt remains uncertain whether transrectal ultrasound (TRUS)-guided systematic biopsies can be omitted and rely solely on multiparametric magnetic resonance imaging–targeted biopsies (MRI-TBx) in biopsy-naïve men suspected of prostate cancer (PCa). ObjectiveTo compare PCa detection in biopsy-naïve men between systematic biopsy and MRI-TBx. Design, setting, and participantsA prospective cohort study was conducted in a Dutch teaching hospital. Consecutive patients with suspected PCa, no history of biopsy, and no clinical suspicion of metastasis underwent both TRUS-guided systematic biopsies and MRI-TBx by multiparametric magnetic resonance imaging (mpMRI)-ultrasound fusion, including sham biopsies in case of negative mpMRI. Outcome measurements and statistical analysisClinically significant PCa (csPCa), defined as group ≥2 on the International Society of Urological Pathology grading, was detected. Results and limitationsThe overall prevalence of csPCa, irrespective of biopsy technique, was 37.4% (132/353) in our population. MRI-TBx were performed in 263/353 (74.5%) patients with suspicious mpMRI (Prostate Imaging Reporting and Data System [PI-RADS] ≥3). The detection rates for csPCa were 39.5% for MRI-TBx and 42.9% for systematic biopsies. The added values, defined as the additional percentages of patients with csPCa detected by adding one biopsy technique, were 8.7% for the systematic biopsies and 5.3% for MRI-TBx. In patients with nonsuspicious mpMRI, five cases (6%) of csPCa were found by systematic biopsies. ConclusionsThis study in biopsy-naïve patients suspected for PCa showed that systematic biopsies have added value to MRI-TBx alone in patients with mpMRI PI-RADS >2. Patient summaryWe studied magnetic resonance imaging (MRI)-guided prostate biopsy for diagnosing prostate cancer and compared it with the standard method of prostate biopsy. Standard systematic biopsies cannot be omitted in patients with suspicious MRI, as they add to the detection of significant prostate cancer.

Quantib Prostate Compared to an Expert Radiologist for the Diagnosis of Prostate Cancer on mpMRI: A Single-Center Preliminary Study.

Background: To evaluate the clinical utility of an Artificial Intelligence (AI) radiology solution, Quantib Prostate, for prostate cancer (PCa) lesions detection on multiparametric Magnetic Resonance Images (mpMRI). Methods: Prostate mpMRI exams of 108 patients were retrospectively studied. The diagnostic performance of an expert radiologist (>8 years of experience) and of an inexperienced radiologist aided by Quantib software were compared. Three groups of patients were assessed: patients with positive mpMRI, positive target biopsy, and/or at least one positive random biopsy (group A, 73 patients); patients with positive mpMRI and a negative biopsy (group B, 14 patients), and patients with negative mpMRI who did not undergo biopsy (group-C, 21 patients). Results: In group A, the AI-assisted radiologist found new lesions with positive biopsy correlation, increasing the diagnostic PCa performance when compared with the expert radiologist, reaching an SE of 92.3% and a PPV of 90.1% (vs. 71.7% and 84.4%). In group A, the expert radiologist found 96 lesions on 73 mpMRI exams (17.7% PIRADS3, 56.3% PIRADS4, and 26% PIRADS5). The AI-assisted radiologist found 121 lesions (0.8% PIRADS3, 53.7% PIRADS4, and 45.5% PIRADS5). At biopsy, 33.9% of the lesions were ISUP1, 31.4% were ISUP2, 22% were ISUP3, 10.2% were ISUP4, and 2.5% were ISUP5. In group B, where biopsies were negative, the AI-assisted radiologist excluded three lesions but confirmed all the others. In group-C, the AI-assisted radiologist found 37 new lesions, most of them PIRADS 3, with 32.4% localized in the peripherical zone and 67.6% in the transition zone. Conclusions: Quantib software is a very sensitive tool to use specifically in high-risk patients (high PIRADS and high Gleason score).

MP43-07 NEGATIVE PROSTATE MRI AS A PREDICTOR OF DISEASE STABILITY IN PATIENTS ON ACTIVE SURVEILLANCE

You have accessJournal of UrologyCME1 May 2022MP43-07 NEGATIVE PROSTATE MRI AS A PREDICTOR OF DISEASE STABILITY IN PATIENTS ON ACTIVE SURVEILLANCE Jacob Enders, Michael Rothberg, Zach Kozel, Michael Daneshvar, Luke O'Connor, Alex Wang, Cheyenne Williams, Nitin Yerram, Sandeep Gurram, Maria Merino, Baris Turkbey, Bradford Wood, and Peter Pinto Jacob EndersJacob Enders More articles by this author , Michael RothbergMichael Rothberg More articles by this author , Zach KozelZach Kozel More articles by this author , Michael DaneshvarMichael Daneshvar More articles by this author , Luke O'ConnorLuke O'Connor More articles by this author , Alex WangAlex Wang More articles by this author , Cheyenne WilliamsCheyenne Williams More articles by this author , Nitin YerramNitin Yerram More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , Maria MerinoMaria Merino More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Bradford WoodBradford Wood More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002609.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Active surveillance (AS) for prostate cancer (PCa) increasingly relies on regularly scheduled imaging with multiparametric MRI (mpMRI) and subsequent prostate biopsy. However, MRI scans are costly and time-consuming, and transrectal biopsies can cause significant patient morbidity due to infection. As such, patients may benefit from avoiding biopsy when the results are unlikely to change clinical management. We sought to identify patients in our AS cohort undergoing annual mpMRI and subsequent MRI-US fusion systematic and targeted biopsy who had no lesions detected on MRI and examine rates and risk factors for disease upgrading. METHODS: A prospectively maintained retrospective database of patients with biopsy-proven PCa on AS at our institution was queried to find patients with no distinct lesion on surveillance mpMRI who underwent subsequent MRI-US fusion biopsy from 2007 to 2019. Patient demographics and information from prostate mpMRI and biopsy were collected, with clinically significant prostate cancer (csPCa) defined as Gleason grade group 2 or higher. A logistic regression model was constructed to examine risk factors for upgrading to csPCa at biopsy using JMP v16.0 (SAS Institute, NC). RESULTS: 466 patients on AS with at least one surveillance mpMRI were identified. Patients underwent an median of 4 MRIs across a median duration on AS of 3.4 years. The median age was 65.0 years (IQR: 60 – 69), median PSA was 5.4 ng/mL (IQR: 3.3 – 7.8), and median PSA density was 0.086 ng/mL/cc (IQR: 0.057 – 0.113). 120/466 (25.7%) patients had at least one surveillance mpMRI showing no distinct lesions in the prostate. Of these, 73/120 (60.8%) patients underwent at least one subsequent biopsy. Across 95 biopsy sessions in these 73 patients, 33/95 (34.7%) showed equal-grade and 47/95 (49.5%) showed lower-grade cancers compared to previous pathology. 10/95 (10.5%) biopsies in 9/73 (12.4%) patients showed upgrading to csPCa. A multivariate logistic regression model showed increased PSA density was a significant predictor of upgrading to csPCa at biopsy (OR: 4.2 for increase of 0.100 ng/mL/cc, 95% CI: 1.5-11.9, p <0.01). CONCLUSIONS: Negative mpMRI while on AS for prostate cancer resulted in equal grading or downgrading in the vast majority of patients undergoing subsequent biopsy. Patients with a negative mpMRI were more likely to be upgraded to csPCa with increasing PSA density. Thus, patients with a negative mpMRI, especially in the setting of a low PSA density, may be able to defer biopsy given the low likelihood for disease upgrading. Source of Funding: The National Institute of Health (NIH) Medical Research Scholars Program, Foundation for the NIH, NIH Intramural Research Program © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e743 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jacob Enders More articles by this author Michael Rothberg More articles by this author Zach Kozel More articles by this author Michael Daneshvar More articles by this author Luke O'Connor More articles by this author Alex Wang More articles by this author Cheyenne Williams More articles by this author Nitin Yerram More articles by this author Sandeep Gurram More articles by this author Maria Merino More articles by this author Baris Turkbey More articles by this author Bradford Wood More articles by this author Peter Pinto More articles by this author Expand All Advertisement PDF DownloadLoading ...

Clinically Significant Prostate Cancer Detection After a Negative Prebiopsy MRI Examination: Comparison of Biparametric Versus Multiparametric MRI.

BACKGROUND. The frequency of clinically significant prostate cancer (csPCa) following negative biparametric MRI (bpMRI) and multiparametric MRI (mpMRI) has not been well investigated in direct comparative studies. OBJECTIVE. The purposes of this study were to compare the frequency of csPCa after negative prebiopsy bpMRI and mpMRI and to evaluate factors predictive of csPCa in the two cohorts. METHODS. This retrospective study included 232 men (mean age, 64.5 years) with negative bpMRI from August 2017 to March 2020 and 193 men (mean age, 69.0 years) with negative mpMRI from January 2018 to December 2018. PI-RADS category 1 or 2 was defined as negative. The study institution offered bpMRI as a low-cost self-pay option for patients without insurer coverage of prebiospy mpMRI. Patient characteristics and subsequent biopsy results were recorded. CsPCa was defined as Gleason score of 3 + 4 or greater. Multivariable regression analyses were performed to identify independent predictors of csPCa. The AUC of PSA density (PSAD) for csPCA was computed, and the diagnostic performance of PSAD was assessed at a clinically established threshold of 0.15 ng/mL2. RESULTS. Systematic biopsy was performed after negative bpMRI for 41.4% (96/232) of patients and after negative mpMRI for 30.5% (59/193) (p = .02). Among those undergoing biopsy, csPCa was present in 15.6% (15/96) in the bpMRI cohort versus 13.6% (8/59) in the mpMRI cohort (p = .69). The NPV for csPCa was 84% (81/96) for bpMRI and 86% (51/59) for mpMRI. In multivariable analyses, independent predictors of csPCa included smaller prostate volume (OR, 0.27; p < .001) and greater PSAD (OR, 3.09; p < .001). In multivariable models, bpMRI (compared with mpMRI) was not independently predictive of csPCa (p > .05). PSAD had an AUC for csPCa of 0.71 (95% CI, 0.56-0.87) in the bpMRI cohort versus 0.68 (95% CI, 0.42-0.93) in the mpMRI cohort. For detecting csPCa, a PSAD threshold of 0.15 ng/mL2 had NPV of 90% and PPV of 28%, in the bpMRI cohort versus NPV of 92% and PPV of 44% in the mpMRI cohort. CONCLUSION. The frequencies of csPCa were not significantly different at systematic biopsy performed after negative bpMRI and mpMRI examinations. PSAD had similar diagnostic utility for csPCa in the two cohorts. CLINICAL IMPACT. Either bpMRI or mpMRI, in combination with PSAD measurement, can help avoid negative prostate biopsies.

How to optimize follow-up in patients with a suspicious multiparametric MRI and a subsequent negative targeted prostate biopsy. Results from a large, single-institution series.

We aimed at optimizing the follow-up for patients with a positive multiparametric magnetic resonance of the prostate (mpMRI) and a subsequent negative targeted biopsy (TBx) plus systematic biopsy (SBx). A total of 308 men with a clinical suspicion of PCa and a positive mpMRI (PI-RADS ≥ 3) with concomitant negative systematic and targeted Bx performed at a single tertiary referral center. All patients were then followed with serial PSA measurements, digital rectal examination and eventual follow-up mpMRI and/or repeat Bx. The primary outcome was to evaluate the overall clinically significant PCa (csPCa)-free survival. The secondary outcome was to assess the role of a repeat mpMRI (Fu-mpMRI) and PSA density as predictors of csPCa diagnosis (defined as Gleason score ≥ 3 + 4) during follow-up. Kaplan Meier analysis and univariable Cox regression were used for survival and predictive analyses. Median follow-up was 31 months (IQR: 23-43). During the study period 116 (37.7%) and 68 (22.1%) of men received a Fu-mpMRI and a Fu-Bx, respectively. Overall, 51 (16.6%) and 15 (4.9%) patients had a positive mpMRI and clinically significant (csPCa) diagnosis during follow-up, respectively. Among 68 men who received a Fu-Bx, the 2- and 3-years csPCa diagnosis-free survival in men with negative vs. positive Fu-mpMRI was 97% vs. 65% and 92% vs. 65%, respectively. At univariate Cox-regression analysis the presence of a positive Fu-mpMRI resulted to be significantly associated with the presence of csPCa at Fu-Bx (HR: 5.8, 95% CI: 1.3-26.6, P = 0.008). The 2- and 3-years csPCa diagnosis-free survival in men with PSAd <0.15 vs. ≥0.15 was 89% vs. 77%, and 86% vs. 66%, respectively (HR: 2.6, 95% CI: 0.75-8.87, P = 0.13). The combination of negative Fu-mpMRI and PSAd<0.15 furtherly reduced the probability of csPCa diagnosis at Fu-Bx at only 6% at 3years (HR: 9.9, 95% CI: 1.9-38.6, P < 0.001) in this subgroup of patients. After a negative TBx for a positive mpMRI, more than half of Fu-mpMRI were negative. A persistent positive mpMRI was associated with a significant risk of csPCa. The risk of csPCa diagnosis in men with negative mpMRI performed after negative TBx and low PSAd was negligible.

Who with suspected prostate cancer can benefit from Proclarix after multiparametric magnetic resonance imaging?

Proclarix is a new blood-based test to assess the likelihood of clinically significant prostate cancer (csPCa) defined as >2 grade group. In this study, we analyzed whether Proclarix and PSA density (PSAD) could improve the selection of candidates for prostate biopsy after multiparametric magnetic resonance imaging (mpMRI). Proclarix and PSAD were assessed in 567 consecutive men with suspected PCa in whom pre-biopsy 3 Tesla mpMRI, scoring with Prostate Imaging-Report and Data System (PI-RADS) v.2, and guided and/or systematic biopsies were performed. Proclarix and PSAD thresholds having csPCa sensitivity over 90% were found at 10% and 0.07 ng/(mL*cm3), respectively. Among 100 men with negative mpMRI (PI-RADS <3), csPCa was detected in 6 cases, which would have been undetected if systematic biopsies were avoided. However, Proclarix suggested performing a biopsy on 70% of men with negative mpMRI. In contrast, PSAD only detected 50% of csPCa and required 71% of prostate biopsies. In 169 men with PI-RADS 3, Proclarix avoided 21.3% of prostate biopsies and detected all 25 cases of csPCa, while PSAD avoided 26.3% of biopsies, but missed 16% of csPCa. In 190 men with PI-RADS 4 and 108 with PI-RADS 5, Proclarix avoided 12.1% and 5.6% of prostate biopsies, but missed 4.8% and 1% of csPCa, respectively. PSAD avoided 18.4% and 9.3% of biopsies, but missed 11.4% and 4.2% csPCa, respectively. We conclude that Proclarix outperformed PSAD in the selection of candidates for prostate biopsy, especially in men with PI-RADS <3.

Nomogram predicting prostate cancer in patients with negative prebiopsy multiparametric magnetic resonance.

Aim: To build two nomograms for predicting the possibilities of prostate cancer (PCa) and clinically significant PCa (csPCa) in patients with negative prebiopsy multiparametric MRI (mpMRI). Methods: The independent predictors associated with PCa or csPCa in patients with negative mpMRI were determined and served in the construction of the two nomograms. Results: The nomogram predicting PCa consisted of age, positive digital rectal examination, free/total prostate-specific antigen (PSA) ratio and PSA density, while age, positive digital rectal examination and PSA density comprised the nomogram predicting csPCa. The negative predictive value of mpMRI for PCa and csPCa improved from 77.1 and 87.5% to 90.4 and 96.1%, respectively, in the training cohort (n=376) and from 81.9 and 89.0% to 91.8 and 96.5%, respectively, in the validation cohort (n=127) when combined with the two nomograms. Conclusion: The negative predictive value of negative mpMRI for the detection of PCa or csPCa was improved with the results of the nomograms.

A0753 - Assessing the role of high-resolution micro-ultrasound among patients with a negative multiparametric MRI and a persistent suspicion of prostate cancer

A0753 - Assessing the role of high-resolution micro-ultrasound among patients with a negative multiparametric MRI and a persistent suspicion of prostate cancer

Determining the diagnostic value of PSMA-PET/CTimaging in patients with persistent high prostate specific antigen levels and negative prostate biopsies.

To assess the diagnostic performance of prostate specific membranous antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging to localize primary prostate cancer (PCa) in men with persistent elevated prostate-specific antigen (PSA) levels and previous prostate biopsies that were negative for PCa. In this study, 34 men with persistently elevated PSA-levels, previous negative for PCa biopsies and who subsequently underwent diagnostic PSMA-PET/CT imaging were retrospectively evaluated. Men were divided into 3 groups: 1. 12 men with a previous negative mpMRI scan (PI-RADS 1-2) 2. 17 men with a positive mpMRI scan (PI-RADS 3-5), but negative MRI-targeted biopsies and 3. Four men in whom mpMRI was contraindicated. If PSMA-avid lesions were seen, patients underwent 2-4 cognitive targeted biopsies in combination with systematic biopsies. The detection rate of PSMA-PET/CT for PCa, and the accuracy of (possible) targeted biopsies were calculated. Included men had a median PSA-level of 22.8 ng/mL (Interquartile Range 15.6-30.0) at the time of PSMA-PET/CT. Elevated PSMA-ligand uptake in the prostate suspicious for PCa was observed in 22/34 patients (64.7%). In 18/22 patients (54.5%), PSMA-targeted prostate biopsies were performed. In 3/18 patients (16.6%), the targeted biopsies showed International Society of Urological Pathology (ISUP) score 1-2 PCa. The other men had inflammation or benign findings after histopathological examination of the biopsy cores. In this study, the clinical value of PSMA-PET/CT for patients with an elevated PSA-level, and negative for PCa biopsies was low. Only very few men were diagnosed with PCa, and no clinically significant PCa was found.

The role of prostate-specific antigen density and negative multiparametric magnetic resonance imaging in excluding prostate cancer for biopsy-naïve men: clinical outcomes from a high-volume center in China.

This study aimed to assess the role of prostate-specific antigen density (PSAD) and negative multiparametric magnetic resonance imaging (mpMRI) in predicting prostate cancer for biopsy-naïve men based on a large cohort of the Chinese population. From a prostate biopsy database between March 2017 and July 2021, we retrospectively identified 240 biopsy-naïve patients with negative prebiopsy mpMRI (Prostate Imaging Reporting and Data System version 2 [PI-RADS v2] score <3). Logistic regression analysis was performed to select the potential predictors for clinically significant prostate cancer (csPCa). Receiver operating characteristic (ROC) curve analysis and area under the ROC curve (AUC) were performed to assess the diagnostic accuracy. The negative predictive values of mpMRI in excluding any cancer and csPCa were 83.8% (201/240) and 90.8% (218/240), respectively. ROC curve analysis indicated that PSAD was the most promising predictor, with an AUC value of 0.786 (95% confidence interval [CI]: 0.699-0.874), and multiparametric logistic regression analysis confirmed that higher PSAD remained a significant marker for predicting csPCa (odds ratio [OR]: 10.99, 95% CI: 2.75-44.02, P < 0.001). Combining negative mpMRI and PSAD below 0.20 ng ml-2 obviously increased the predictive value in excluding PCa (91.0%, 101/111) or csPCa (100.0%, 111/111). If a PSAD below 0.20 ng ml-2 was set as the criterion to omit biopsy, nearly 46.3% of patients (463 per 1000) with negative mpMRI could safely avoid unnecessary biopsy, with approximately 4.2% of patients (42 per 1000) at risk of missed diagnosis of PCa and no patients with csPCa missed. A PI-RADS v2 score <3 and a PSAD <0.20 ng ml-2 could be potential criteria for the Chinese population to omit prompt biopsy safely.

Prostate cancer detection rate in men undergoing transperineal template-guided saturation and targeted prostate biopsy.

ObjectivesTo compare prostate cancer (PCa) detection rate of transperineal template‐guided saturation prostate biopsy (SBx) and multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound fusion guided targeted biopsy (TBx).Materials and MethodsWe prospectively enrolled 392 men who underwent SBx and TBx in case of suspicious lesions from November 2016 to October 2019. Triggers for a biopsy were an elevated prostate‐specific antigen (PSA) and/or positive digital rectal examination and only treatment naïve patients without a previous diagnosis of PCa were included. Study inclusion occurred before biopsy and a prebiopsy mpMRI was available in all men. SBx were taken from 20 different locations according to the modified Barzell zones. The primary endpoint was the detection rate of clinically significant PCa (csPCa) and insignificant PCa (ciPCa) by SBx and/or TBx by comparing the two methods alone and in combination. Additional TBx were taken for any prostate imaging–reporting and data system (PI‐RADS) lesion ≥3 seen on the mpMRI. csPCa was defined as any Gleason score ≥7 and ciPCa as Gleason score 6.ResultsA total of 392 men with a median age of 64 years (interquartile range [IQR]: 58–69), a median PSA of 7.0 ng/ml (IQR: 4.8–10.1) were enrolled. Overall, PCa was found in 200 (51%) of all biopsied men, with 158 (79%) being csPCa and 42 (21%) ciPCa. A total of 268 (68%) men with a suspicious mpMRI and underwent a combined TBx and SBx, of whom csPCa was found in 139 (52%). In this subgroup, 116/139 (83%) csPCa would have been detected by TBx alone, and an additional 23 (17%) were found by SBx. Men with a negative mpMRI (PI‐RADS < 3, n = 124, 32%) were found to have csPCa in 19 (15%) cases. In patients with a negative mpMRI in combination with a PSA density <0.1 ng/ml2, only 8% (3/36) had csPCa. If only TBx would have been performed and all men with a negative mpMRI would not have been biopsed, 42/158 (27%) of csPCa would have been missed, and 38/42 (90%) ciPCa would have not been detected. On multivariable analysis, significant predictors of csPCa were increasing PSA (odds ratio, OR: 1.07 [95% confidence interval, CI: 1.03–1.11]), increasing age (OR: 1.07 [95% CI: 1.03–1.11]), PI‐RADS score ≥ 3 (OR: 6.49 [95% CI: 3.55–11.89]), and smaller prostate volume (OR: 0.96 [95% CI: 0.95 –0.97] (p < 0.05 for all parameters).ConclusionIn comparison to SBx, TBx alone detects csPCa in only ¾ of all men with a positive mpMRI lesion. Thus, systematic biopsies in addition to TBx have to be considered at least in some who undergo a prostate biopsy. In men with a negative mpMRI, SBx still detects 15% csPCa, but similarly overdetecting ciPCa. According to our results, low PSA density and negative mpMRI findings could be used to decide which men can safely avoid biopsy.

Multiparametric Prostate MRI in Biopsy-Naïve Men: A Prospective Evaluation of Performance and Biopsy Strategies.

ObjectivesThis study aims to prospectively estimate the diagnostic performance of multiparametric prostate MRI (mpMRI) and compare the detection rates of prostate cancer using cognitive targeted transrectal ultrasound (TRUS) guided biopsies, targeted MR-guided in-bore biopsies (MRGB), or both methods combined in biopsy-naïve men.MethodsThe biopsy-naïve men referred for mpMRI (including T2-weighted, diffusion-weighted and dynamic contrast enhanced MRI) due to prostate cancer suspicion (elevated prostate-specific antigen or abnormal digital rectal examination) were eligible for inclusion. The images were scored according to Prostate Imaging Reporting and Data System (PI-RADS) v2, and men with PI-RADS 1–2 lesions were referred for routine systematic TRUS, while those with PI-RADS 3–5 lesions were randomized to MRGB or cognitive targeted TRUS. Men randomized to MRGB were referred to a secondary TRUS 2 weeks after MRGB. Gleason grade group ≥2 was defined as clinically significant prostate cancer. The performance of mpMRI was estimated using prostate cancer detected by any biopsy method as the reference test.ResultsA total of 210 men were included. There was no suspicion of prostate cancer after mpMRI (PI-RADS 1–2) in 48% of the men. Among these, significant and insignificant prostate cancer was diagnosed in five and 11 men, respectively. Thirty-five men who scored as PI-RADS 1–2 did not undergo biopsy and were therefore excluded from the calculation of diagnostic accuracy. The overall sensitivity, specificity, negative predictive value, and positive predictive value of mpMRI for the detection of significant prostate cancer were 0.94, 0.63, 0.92, and 0.67, respectively. In patients with PI-RADS 3–5 lesions, the detection rates for significant prostate cancer were not significantly different between cognitive targeted TRUS (68.4%), MRGB (57.7%), and the combination of the two biopsy methods (64.4%). The median numbers of biopsy cores taken per patient undergoing systematic TRUS, cognitive targeted TRUS, and MRGB were 14 [8-16], 12 [6-17], and 2 [1-4] respectively.ConclusionsmpMRI, in a cohort of biopsy-naïve men, has high negative predictive value, and our results support that it is safe to avoid biopsy after negative mpMRI. Furthermore, MRGB provides a similar diagnosis to the cognitive targeted TRUS but with fewer biopsies.

PD17-07 IS CONFIRMATORY BIOPSY STILL NECESSARY IN MEN WITH GRADE GROUP 1 PROSTATE CANCER IN THE MULTIPARAMETRIC MRI ERA?

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance I (PD17)1 Sep 2021PD17-07 IS CONFIRMATORY BIOPSY STILL NECESSARY IN MEN WITH GRADE GROUP 1 PROSTATE CANCER IN THE MULTIPARAMETRIC MRI ERA? Yasin Bhanji, Mufaddal Mamawala, Sean Fletcher, Patricia Landis, Katarzyna Macura, and Christian Pavlovich Yasin BhanjiYasin Bhanji More articles by this author , Mufaddal MamawalaMufaddal Mamawala More articles by this author , Sean FletcherSean Fletcher More articles by this author , Patricia LandisPatricia Landis More articles by this author , Katarzyna MacuraKatarzyna Macura More articles by this author , and Christian PavlovichChristian Pavlovich More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001999.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men with low-risk prostate cancer (PCa) considering active surveillance (AS) undergo a confirmatory biopsy (CB) within 6-12 months of diagnostic biopsy (DB) to guide decision-making for inclusion in AS protocols. Other clinical variables, such as PSA and multiparametric prostate MRI (mpMRI), are also used to determine AS eligibility. We sought to compare rates of upgrading on CB between men who received a pre-DB MRI and those who did not. We hypothesized that the upgrading rate would be comparatively lower in men with a pre-DB mpMRI. METHODS: We studied a cohort of men diagnosed with GG1 PCa on DB who underwent CB in 2019-2020. Patients were stratified into two groups (Figure). The first group underwent mpMRI prior to DB; if a PIRADS≥3 lesion was present, the patient received systematic biopsy (SB) + targeted biopsy (TB). If no lesion was present, then only SB was performed. The second group underwent DB without mpMRI, then had mpMRI prior to CB which followed the aforementioned biopsy protocol. Primary outcome was detection on CB of Gleason ≥3+4 (Grade Group [GG]≥2) PCa. RESULTS: 247 men had a DB demonstrating only GG1 PCa. 111 of these (44%) underwent pre-biopsy mpMRI and thus MRI-informed DB (Group 1), of whom 28 (25%) upgraded to GG>1 at CB. 136 men (55%) underwent DB followed by mpMRI-informed CB (Group 2), of whom 30 (22%) upgraded to GG>1 at CB. 41 (37%) men in Group 1 had a negative mpMRI (PI-RADS≤2) and of these, 7 (17%) were diagnosed with GG>1 PCa at CB (NPV of mpMRI for GG>1= 83%). 62 (45%) men in group 2 had a negative mpMRI, 7 (11.2%) of whom were diagnosed with GG>1 prostate cancer at CB (NPV 89%; p=0.6 compared to group 1). Time interval between DB and CB was not associated with upgrading overall or in either group. CONCLUSIONS: Rates of upgrading to GG>1 on CB were similar in men who had an mpMRI-informed DB (25%) and in those who did not have a pre-DB mpMRI (22%). This suggests that men considering AS benefit from a CB (SB+TB as needed) regardless of the presence of pre-DB mpMRI or of mpMRI findings. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e287-e287 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Yasin Bhanji More articles by this author Mufaddal Mamawala More articles by this author Sean Fletcher More articles by this author Patricia Landis More articles by this author Katarzyna Macura More articles by this author Christian Pavlovich More articles by this author Expand All Advertisement Loading ...

Identifying Risk Factors for MRI-Invisible Prostate Cancer in Patients Undergoing Transperineal Saturation Biopsy

PurposeProstatic multi-parametric magnetic resonance imaging (mpMRI) has markedly improved the assessment of men with suspected prostate cancer (PCa). Nevertheless, as mpMRI exhibits a high negative predictive value, a negative MRI may represent a diagnostic dilemma. The aim of this study was to evaluate the incidence of positive transperineal saturation biopsy in men who have negative mpMRI and to analyse the factors associated with positive biopsy in this scenario.Patients and MethodsA retrospective study of men with normal mpMRI and suspicion of PCa who underwent saturation biopsy (≥20 cores) was carried out. A total of 580 patients underwent transperineal MRI/transrectal ultrasound fusion targeted biopsies or saturation prostate biopsies from January 2017 to September 2020. Of them, 73 had a pre-biopsy negative mpMRI (with Prostate Imaging – Reporting and Data System, PI-RADS, ≤2) and were included in this study. Demographics, clinical characteristics, data regarding biopsy results and potential predictive factors of positive saturation biopsy were collected. Univariate and multivariate logistic regression analyses were used to identify independent risk factors for MRI-invisible PCa.ResultsThe detection rate of PCa with saturation biopsy in patients with negative MRI was 34/73 (46.58%). Out of 34 MRI-invisible prostate cancers detected, 12 (35.29%) were clinically significant PCa (csPCa) forms. Regarding factors of positive biopsy, in univariate analysis, the use of 5-alpha reductase inhibitors and free:total prostate-specific antigen (PSA) ratio were associated with the result of the saturation biopsy. In multivariate analysis, only an unfavourable free:total PSA ratio remained a risk factor (OR 11.03, CI95% 1.93–63.15, p=0.01). Furthermore, multivariate logistic analysis demonstrated that prostate volume >50mL significantly predicts the absence of csPCa on saturation biopsy (OR 0.11, 95% CI 0.01–0.94, p=0.04).ConclusionA free:total PSA ratio <20% is a risk factor for MRI-invisible PCa. Saturation biopsy could be considered in patients with suspected PCa, despite having a negative MRI.

Can Prostate-Specific Antigen Density Be an Index to Distinguish Patients Who Can Omit Repeat Prostate Biopsy in Patients with Negative Magnetic Resonance Imaging?

PurposeWe evaluated the negative predictive value (NPV) of multiparametric magnetic resonance imaging (mpMRI) in detecting clinically significant prostate cancer (csPCa) according to biopsy setting and prostate-specific antigen density (PSAD) using transperineal template-guided saturation prostate biopsy (TPB) as the reference standard.MethodsA total of 161 patients with biopsy histories and negative pre-biopsy mpMRI (Prostate Imaging Reporting and Data System version 2 scores of less than 3) participated in the study. TPB was performed on the following indications: “prior negative biopsy” in patients with persistent suspicion of prostate cancer (n = 91) or “confirmatory biopsy” in patients who were candidates for active surveillance (n = 70). The csPCa was defined as a Gleason score of 3 + 4 or greater. We calculated the NPV of mpMRI in detecting csPCa according to biopsy history and prostate-specific antigen density (PSAD) and conducted a logistic regression analysis to determine the clinical predicator for the absence of csPCa.ResultsThe detection rate of csPCa was 5.5% in the prior negative biopsy group and 14.3% in the confirmatory biopsy group (P = 0.057). None of the variables in the logistic regression models including PSAD <0.15 ng/mL/cc and prior negative biopsy could predict the absence of csPCa. The NPV of mpMRI in detecting csPCa in patients with a prior negative biopsy worsen from 94.5% to 93.3% when combined with PSAD <0.15 ng/mL/cc.ConclusionPatients with negative mpMRI findings may not omit repeat biopsy even if their prior biopsy histories are negative and PSADs are <0.15 ng/mL/cc.

Integrative Machine Learning Prediction of Prostate Biopsy Results From Negative Multiparametric MRI.

Multiparametric MRI (mpMRI) is commonly recommended as a triage test prior to any prostate biopsy. However, there exists limited consensus on which patients with a negative prostate mpMRI could avoid prostate biopsy. To identify which patient could safely avoid prostate biopsy when the prostate mpMRI is negative, via a radiomics-based machine learning approach. Retrospective. Three hundred thirty patients with negative prostate 3T mpMRI between January 2016 and December 2018 were included. A 3.0 T/T2-weighted turbo spin echo (TSE) imaging (T2 WI) and diffusion-weighted imaging (DWI). The integrative machine learning (iML) model was trained to predict negative prostate biopsy results, utilizing both radiomics and clinical features. The final study cohort comprised 330 consecutive patients with negative mpMRI (PI-RADS < 3) who underwent systematic transrectal ultrasound-guided (TRUS) or MR-ultrasound fusion (MRUS) biopsy within 6 months. A secondary analysis of biopsy naïve subcohort (n=227) was also conducted. The Mann-Whitney U test and Chi-Squared test were utilized to evaluate the significance of difference of clinical features between prostate biopsy positive and negative groups. The model performance was validated using leave-one-out cross-validation (LOOCV) and measured by AUC, sensitivity, specificity, and negative predictive value (NPV). Overall, 306/330 (NPV 92.7%) of the final study cohort patients had negative biopsies, and 207/227 (NPV 91.2%) of the biopsy naïve subcohort patients had negative biopsies. Our iML model achieved NPVs of 98.3% and 98.0% for the study cohort and subcohort, respectively, superior to prostate-specific antigen density (PSAD)-based risk assessment with NPVs of 94.9% and 93.9%, respectively. The proposed iML model achieved high performance in predicting negative prostate biopsy results for patients with negative mpMRI. With improved NPVs, the proposed model can be used to stratify patients who in whom we might obviate biopsies, thus reducing the number of unnecessary biopsies. 3 TECHNICAL EFFICACY: Stage 2.