Biopsy In Men Research Articles

Histo-MRI map study protocol: a prospective cohort study mapping MRI to histology for biomarker validation and prediction of prostate cancer

IntroductionMultiparametric MRI (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. However, the technique has modest specificity and...

Early experience in avoiding biopsies for biopsy-naïve men with clinical suspicion of prostate cancer but non-suspicious biparametric magnetic resonance imaging results and prostate-specific antigen density < 0.15ng/mL2: A 2-year follow-up study.

BackgroundOnly limited data have been published on the diagnostic accuracy of combining biparametric (bp) magnetic resonance imaging (MRI) and prostate-specific antigen density (PSAd) to rule out biopsies.PurposeThe purpose is to assess the 2-year risk of being diagnosed with sPCa following the strategy of avoiding immediate biopsies in men with non-suspicious bp MRIs and a PSAd <0.15 ng/mL2.Material and MethodsTwo hundred biopsy-naïve men with clinical suspicion of PCa underwent a pre-biopsy bp MRI from March to July 2019. Of these, 109 men had a Prostate Imaging Reporting and Data System (PI-RADS) score of 1–3 including 77 men with calculated PSAd <0.15 ng/mL2. As a result, no biopsies were performed in these 77 men, who were clinically followed up for at least 2 years and re-examined in case of rising suspicion of sPCa. The remaining 32 men with a calculated PSAd ≥0.15 ng/mL2 underwent systematic biopsies and targeted biopsies of any PI-RADS 3 lesion.ResultsOne of the 77 men (1.3%) had an sPCa diagnosed within 2 years of follow-up. All men were referred back to their general practitioner within 1 year and 9% (7/77) were re-referred to the urology department during follow-up. Among these men, 43% (3/7) continued to have PSA levels that were above their individual thresholds at confirmatory testing and underwent secondary MRI scans.ConclusionsNo biopsies for men with bpMRI results exhibiting maximum PI-RADS 3 and with a PSAd <0.15 ng/mL2 resulted in a 2-year risk of being diagnosed with sPCa of 1.3%.

Oncologic Outcomes of Total Length Gleason Pattern 4 on Biopsy in Men with Grade Group 2 Prostate Cancer.

Gleason Score 7 prostate cancer comprises a wide spectrum of disease risk, and precise substratification is paramount. Our group previously demonstrated that the total length of Gleason pattern (GP) 4 is a better predictor than %GP4 for adverse pathological outcomes at radical prostatectomy. We aimed to determine the association of GP4 length on prostate biopsy with post-prostatectomy oncologic outcomes. We compared 4 GP4 quantification methods-including maximum %GP4 in any single core, overall %GP4, total length GP4 (mm) across all cores and length GP4 (mm) in the highest volume core-for prediction of biochemical recurrence-free survival after radical prostatectomy using multivariable Cox proportional hazards regression. A total of 457 men with grade group 2 prostate cancer on biopsy subsequently underwent radical prostatectomy. The 3-year biochemical recurrence-free survival probability was 85% (95% CI 81-88). On multivariable analysis, all 4 GP4 quantification methods were associated with biochemical recurrence-maximum %GP4 (HR=1.30; 95% CI 1.07-1.59; p=0.009), overall %GP4 (HR=1.61; 95% CI 1.21-2.15; p=0.001), total length GP4 (HR=2.48; 95% CI 1.36-4.52; p=0.003) and length GP4 in highest core (HR=1.32; 95% CI 1.11-1.57; p=0.001). However, we were unable to identify differences between methods of quantification with a relatively low event rate. These findings support further studies on GP4 quantification in addition to the ratio of GP3 and GP4 to classify prostate cancer risk. Research should also be conducted on whether GP4 quantification could provide a surrogate endpoint for disease progression for trials in active surveillance.

High diagnostic accuracy of inguinal ultrasonography and fine-needle aspiration followed by dynamic sentinel lymph node biopsy in men with impalpable and palpable inguinal lymph nodes.

To assess the accuracy of dynamic sentinel lymph node biopsy (DSNB) after negative ultrasonography (US) guided fine-needle aspiration (FNA) for inguinal lymph node (ILN) staging. We performed a retrospective analysis of men with ≥T1G2 penile cancer and negative inguinal US-guided FNA undergoing DSNB. Men with suspicious US but negative FNA underwent US-guided ILN excision. Men with ≥T1G2 local recurrence during follow-up and non-squamous cell histologies were excluded. Descriptive analysis was performed, and sensitivity and negative predictive values (NPVs) were calculated. We included 403 men with 728 groins with negative FNA undergoing DSNB ± US-guided LN excision. At least one sentinel LN (SN) was visualised in 93% during the first and in 7% during the second lymphoscintigraphy. The median SNs visualised preoperatively was 1 SN and a median of 2 LNs were resected. ILN metastases were detected in 9% groins in men with impalpable and in 17% men with palpable LNs. Stratified by impalpable and palpable ILN, non-local recurrence despite pathologically negative DSNBs was seen in 0.5% and 0%, respectively. Limited to men with ≥24 months follow-up, non-local recurrence after negative DSNBs was seen in 0.4% and 0%, respectively. The sensitivity of DSNB was 96% and the NPV was 100%. The main limitation of this analysis is its retrospective nature with inherit biases. Inguinal US and FNA followed by DSNB can accurately stage men with both impalpable and palpable ILN, which provides logistical and surgical advantages.

High-diagnostic accuracy of inguinal ultrasonography and fine needle aspiration followed by dynamic sentinel lymph node biopsy in men with non-palpable and palpable inguinal lymph nodes.

6 Background: Penile cancer undergoes a stepwise dissemination and metastasises first to the inguinal lymph nodes (ILN). Because men can be cured in this early stage of metastatic disease, early detection and treatment is important. Methods: We performed a retrospective analysis of men with ≥T1G2 penile cancer and negative inguinal US guided FNA undergoing DSNB. Men with suspicious US but negative FNA underwent US guided ILN excision. Men with ≥T1G2 local recurrence during follow-up and non-squamous cell histologies were excluded. Descriptive analysis was performed, and sensitivity and negative predictive values (NPV) were calculated. Results: The final cohort consisted of 403 men with a median age of 65 years (IQR 55-73) and body mass index (BMI) of 28.6 kg/m² (IQR 25-33) for this analysis. This gave 728 groins with negative FNA undergoing DSNB +/- US guided lymph node excision. At least one sentinel node (SN) was visualised in 93% during the 1st and in 7% during the 2nd lymphoscintigraphy. Median SNs visualised preoperatively was 1 and a median of 2 nodes were resected. ILN metastases were detected in 9% groins with non-palpable and in 17% with palpable lymph nodes. Stratified by non-palpable and palpable ILN, non-local recurrence despite pathologically negative DSNBs was observed in 0.5% and 0%. Limited to men with at least 24 months follow-up, non-local recurrence after negative DSNBs was observed in 0.4% and 0%. The sensitivity of DSNB was 96% and NPV was 100%. The main limitation of this analysis is its retrospective nature and inherit biases. Conclusions: Our results suggest that in a high volume centre pre-operative ultrasound +/- FNA and DSNB can be used to accurately stage men with non-palpable and palpable ILN in men with ≥T1G2 penile cancer. Further, FNA in advance of surgery provides logistical and surgical advantages. In those patients with palpable disease but negative FNA, we advocate ultrasound guided excision in case of enlarged or suspicious ILN during DSNB.[Table: see text]

A0272 - 3-year outcomes from the prospective ‘MRIAS’ trial: A novel active surveillance protocol which incorporates multiparametric MRI to reduce frequency of biopsy in men with prostate cancer

A0272 - 3-year outcomes from the prospective ‘MRIAS’ trial: A novel active surveillance protocol which incorporates multiparametric MRI to reduce frequency of biopsy in men with prostate cancer

Cost-Effectiveness of Multiparametric Magnetic Resonance Imaging and Targeted Biopsy Versus Systematic Transrectal Ultrasound-Guided Biopsy for Prostate Cancer Diagnosis: A Systematic Review

ObjectivesThis study aimed to systematically review the cost-effectiveness studies of multiparametric magnetic resonance imaging (mpMRI)-guided biopsy (MRGB) compared with systematic transrectal ultrasonography (TRUS)-guided biopsy for diagnosing prostate cancer (PCa). MethodsPubMed, Web of Science core collection, Embase and Scopus, and reference lists of the included studies were searched with no date and language restrictions through January 2020 for full economic evaluation studies (cost-effectiveness, cost-utility analysis, cost-benefit analysis) that assessed mpMRI and MRGB compared with systematic TRUS-guided biopsy or other sequential biopsy strategies in men undergoing initial prostate biopsy or men with previous negative prostate biopsy, with clinical suspicion of PCa based on abnormal prostate-specific antigen or digital rectal examination increase or both. Data were tabulated and analyzed using narrative synthesis. The reporting quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. This systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. ResultsFinally, 9 studies were included. All studies were conducted in high-income countries. All studies found that mpMRI and MRGB was cost-effective in the initial and before repeat biopsy in men with previous negative biopsy. The cognitive-targeted TRUS-guided biopsy was cost-effective in the initial biopsy (dominant or cost-effective at willingness-to-pay threshold of the countries); it was not evaluated for repeat biopsy in men. The direct in-bore magnetic resonance imaging (MRI)-guided biopsy was cost-effective for the initial biopsy (€323 per quality-adjusted life-year gained). The superiority of one of the targeted biopsy approaches (fusion, cognitive, or in-bore) over other approaches has not yet been established. ConclusionsThis study showed that pre-TRUS-guided biopsy MRI is more cost-effective than TRUS-guided biopsy alone. Furthermore, the use of MRI-ultrasound fusion targeted biopsy in the diagnosis of PCa in the initial biopsy and repeat biopsy and cognitive-targeted TRUS-guided biopsy in the initial biopsy is cost-effective.

The Efficacy of Proclarix to Select Appropriate Candidates for Magnetic Resonance Imaging and Derived Prostate Biopsies in Men with Suspected Prostate Cancer.

PurposeTo analyze how Proclarix is valuable to appropriately select candidates for multiparametric magnetic resonance imaging (mpMRI) and derived biopsies, among men with suspected prostate cancer (PCa). Proclarix is a new marker computing the clinically significant PCa (csPCa) risk, based on serum thosmbospondin-1, cathepsin D, prostate-specific antigen (PSA) and percent free PSA, in addition to age, that has been developed in men with serum PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and normal digital rectal examination (DRE).Materials and MethodsProclarix score (0%–100%) is analyzed in a prospective frozen serum collection of 517 correlative men scheduled for guided and/or systematic biopsies after mpMRI. Outcome variables were csPCa detection (grade group ≥2), insignificant PCa (iPCa) overdetection and avoided mpMRIs.ResultsThe area under the curve of Proclarix was 0.701 (95% CI 0.637–0.765) among 281 men with serum PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and -normal DRE, and 0.754 (95% CI 0.701–0.807) in the others, p=0.038. Net benefit of Proclarix existed in all men. After selecting 10% threshold, Proclarix was integrated in an algorithm which also used the serum PSA level and DRE. A reduction of 25.4% of mpMRIs request was observed and 17.7% of prostate biopsies. Overdetection of iPCa was reduced in 18.2% and 2.6% of csPCa were misdiagnosed.ConclusionsProclarix is valuable in all men with suspected PCa. An algorithm integrating Proclarix score, serum PSA, and DRE can avoid mpMRI requests, unnecessary prostate biopsies and iPCa overdetection, with minimal loss of csPCa detection.

Current biomarkers of prostate cancer

Prostate cancer is one of the most common malignancies in men. Early detection of prostate cancer is largely determined by the widely used prostate specific antigen (PSA) blood test. However, as a diagnostic and prognostic test of prostate cancer, PSA has limited specificity, sensitivity and leads to hyper or underdiagnosis, which, in turn, can lead to excessive treatment. There fore, it is very important to develop diagnostic markers that can be used to determine prostate cancer at an early stage of development, assess the possible progression of the disease and prescribe optimal therapy. Significant progress has been made in the discovery of biomarkers for prostate cancer. For example, biomarkers such as %-free PSA, Prostate Health Index (PHI) or 4K score can be used to increase specificity and reduce the number of unnecessary biopsies, while the PCA3 test can be used to reduce the number of repeated biopsies in men with previously negative biopsy. To determine aggressiveness and predict the outcome of the disease, tissue multigenic tests can be used, such as: T2-ERG, ExoDx, SelectMDx and ConfirmMDx, Prolaris, Oncoytype DX, Decipher. The development of such diagnostic tests opens up new opportunities for improving the diagnosis of prostate cancer, prognosis and decision-making on the appointment of therapy. And with the increase in their availability, finally, the possibility of an individual approach to the appointment of treatment for men with prostate cancer appears on the horizon. This review paper presents the data on the most advanced diagnostic biomarkers of prostate cancer.

A non-inferiority comparative analysis of micro-ultrasonography and MRI-targeted biopsy in men at risk of prostate cancer.

To compare the efficacy of multiparametric magnetic resonance imaging (mpMRI)-directed and micro-ultrasonography (micro-US)-directed biopsy for detecting clinically significant (Grade Group >1) prostate cancer (csPCa). A total of 203 patients were prospectively enrolled at three institutions across Germany and Austria in the period from January 2019 to December 2019. During each biopsy, the urologist was blinded to the mpMRI report until after the micro-US targets had been assessed. After unblinding, targets were then sampled using software-assisted fusion, followed by systematic samples. The primary outcome measure was non-inferiority of micro-US to detect csPCa, with a detection ratio of at least 80% that of mpMRI. A total of 79 csPCa cases were detected overall (39%). Micro-US-targeted biopsy detected 58/79 cases (73%), while mpMRI-targeted biopsy detected 60/79 (76%) and non-targeted (completion sampling) samples detected 45/79 cases (57%). mpMRI-targeted samples alone detected 7/79 (9%) csPCa cases which were missed by micro-US-targeted and non-targeted samples. Three of these seven were anterior lesions with 2/7 in the transition zone. Micro-US-targeted samples alone detected 5/79 (6%) and completion sampling alone detected 4/79 cases (5%). Micro-US was non-inferior to mpMRI and detected 97% of the csPCa cases detected by mpMRI-targeted biopsy (95% CI 80-116%; P = 0.023). This is the first multicentre prospective study comparing micro-US-targeted biopsy with mpMRI-targeted biopsy. The study provides further evidence that micro-US can reliably detect cancer lesions and suggests that micro-US biopsy might be as effective as mpMRI for detection of csPCA. This result has significant implications for increasing accessibility, reducing costs and expediting diagnosis.

Simultaneous analysis of serum α2,3-linked sialylation and core-type fucosylation of prostate-specific antigen for the detection of high-grade prostate cancer

Altered prostate-specific antigen (PSA) glycosylation patterns can be useful biomarkers in detecting high-grade prostate cancer (HGPC). The microfluidic immunoassay system can analyse α2,3-linked sialylated PSA (α2,3-Sia-PSA) and α1,6-linked fucosylated PSA (α1,6-Fuc-PSA) using different lectins, Mackkia amurensis agglutinin and Pholiota squarrosa lectin, respectively. Here, we investigated the diagnostic value of simultaneous analysis of α2,3-Sia-PSA and α1,6-Fuc-PSA for the detection of HGPC. Men with serum PSA levels of 4-20 ng/mL who underwent prostate biopsy were included. The model to predict HGPC (Gleason grade ≥2) was constructed by multivariate logistic regression analysis, in combination with α2,3-Sia-PSA and α1,6-Fuc-PSA (SF index). In the development cohort (n = 150), the SF index showed good discrimination for HGPC (area under the receiver-operating curve (AUC) 0.842; 95% confidence interval (CI) 0.782-0.903), compared to the single PSA test (AUC 0.632, 95% CI 0.543-0.721), α2,3-Sia-PSA (AUC 0.711, 95% CI 0.629-0.793) and α1,6-Fuc-PSA (AUC 0.738, 95% CI 0.657-0.819). Decision-curve analysis showed the superior benefit of the SF index. In the validation cohort (n = 57), the SF index showed good discrimination for HGPC (AUC 0.769, 95% CI 0.643-0.895). The SF index could differentiate HGPC, providing useful information for decision making for prostate biopsy in men with abnormal PSA levels.

Optimization of prostate biopsy - Micro-Ultrasound versus MRI (OPTIMUM): A 3-arm randomized controlled trial evaluating the role of 29 MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer

BackgroundMicro-ultrasound (microUS) is a novel ultrasound-based imaging modality which has demonstrated the ability to visualize prostate cancer. Multiparametric MRI/ultrasound (mpMRI/US) fusion has recognized advantages for the performance of prostate biopsy, however, it encompasses additional cost, time and technical expertise to performing prostate biopsy in comparison to conventional trans-rectal ultrasound biopsy. MicroUS may simplify and optimize this pathway. MethodsOPTIMUM is a 3-arm randomized controlled trial comparing microUS guided biopsy with MRI/US fusion and MRI/MicroUS “contour-less” fusion. This trial will investigate whether microUS alone, or in combination with mpMRI, provides effective guidance during prostate biopsy for the detection of clinically significant prostate cancer (csPCa) for biopsy naïve subjects. 1200 subjects will be randomized. The economic impact will be evaluated. ResultsThe rate of csPCa (defined as Grade Group 2 and above) in each arm will be compared. The primary hypothesis is non-inferiority of csPCa rate between the MRI/US fusion arm and the microUS-only arm (including the blinded microUS-only portion of the MRI/MicroUS arm). As a secondary objective, the csPCa rate between MRI/MicroUS fusion and MRI/US fusion arms will also be compared. Other secondary objectives include the increase in rate of patients diagnosed with csPCa due to each type of sample (mpMRI targeted, microUS targeted, systematic), the negative predictive value of each imaging modality, and a health economic analysis of the procedures in each arm. ConclusionsOPTIMUM will determine whether microUS can be used as an alternative to MRI/US fusion biopsy. The trial will also evaluate the efficacy of the simplified “contour-less” MRI/MicroUS fusion procedure. The adoption of the microUS technique will increase the proportion of men who can benefit from modern imaging-centric diagnostic strategies, and may help reduce variability, complexity, waiting time and cost within the diagnostic pathway.

Imaging of Prostate Cancer.

Prostate cancer is the most common type of solid tumor in men and the second most common cause of cancer-related death in males in Germany. The conventional strategy for its primary detection, i.e., systematic ultrasound-guided prostate biopsy in men who have elevated PSA levels and/or positive findings on digital rectal examination, fails to reveal all cases. The same is true of the use of conventional computed tomography (CT), magnetic resonance imaging (MRI), and skeletal scintigraphy for the early detection of recurrences and distant metastases. This review is based on pertinent publications retrieved by a selective search, including the German clinical practice guideline on prostate cancer and systematic review articles. Prospective multicenter trials have shown that the detection of clinically significant prostate cancer is markedly improved with multiparametric MRI (mpMRI) and MR/TRUS fusion biopsy (TRUS = transrectal ultrasonography), compared to conventional systematic biopsy. A recent Cochrane review showed that the rate of overdiagnosis of low-risk prostate cancer was reduced with mpMRI and MR/TRUS fusion biopsy compared with conventional systematic biopsy (95/1000 vs. 139/1000), and that clinically significant prostate cancer was more reliably detected (sensitivity 72% vs. 63%), albeit with slightly lower specificity (96% vs. 100%). Prostate- specific membrane antigen (PSMA) hybrid imaging improves the detection of lymphogenic and bony metastases in patients with high-risk prostate cancer. PSMA hybrid imaging is most commonly used to detect biochemical recurrences. A metaanalysis showed that the detection rate depends on the PSA concentration: 74.1% overall, 33.7% with PSA <0.2 ng/mL, and 91.7% with PSA ≥= 2.0 ng/mL. The appropriate use of mpMRI and MR/TRUS fusion biopsy improves the initial detection of prostate cancer as well as the assessment of the prognosis. PSMA hybrid imaging is useful for the staging of high-risk patients and for the detection of recurrences. These methods are now recommended in the German clinical practice guideline on prostate cancer as well as in guidelines from other countries.

Multiparametric Magnetic Resonance Imaging-Ultrasound Fusion Transperineal Prostate Biopsy: Diagnostic Accuracy from a Single Center Retrospective Study.

Simple SummaryThe introduction of imaging techniques has improved the diagnostic pathway for prostate cancer. In this study we compared the diagnostic accuracy of multiparametric MRI with fusion ultrasound-guided prostate biopsy and standard biopsy, both performed through the transperineal route. Our results support the combined targeted and standard biopsy pathway to reduce the risk of missing clinically significant prostate cancer.The management of prostate biopsy in men with clinical suspicion of prostate cancer has changed in the last few years, especially with the introduction of imaging techniques, to overcome the low efficacy of risk stratification based on PSA levels. Here, we aimed to compare the diagnostic accuracy of multiparametric MRI with fusion ultrasound-guided prostate biopsy and standard biopsy, both performed through the transperineal route. To this end, we retrospectively analyzed 272 patients who underwent combined transperineal targeted and standard biopsy during the same session. The primary outcome was to compare the cancer detection rate between targeted and standard biopsy. The secondary outcome was to evaluate the added value of combined targeted and standard biopsy approach as compared to only targeted or standard biopsy. Results showed that a rate of 16.7% clinically significant tumors (International Society of Urological Pathology (ISUP) grade ≥ 2) would have been lost if only the standard biopsy had been used. The combined targeted and standard biopsy showed an added value of 10.3% and 9.9% in reducing the risk of prostate cancer missing after targeted or standard biopsy alone, respectively. The combined targeted and standard biopsy pathway is recommended to reduce the risk of missing clinically significant prostate cancer.

FSH levels and testicular volumes are associated with the severity of testicular histopathology in men with non-obstructive azoospermia

PurposeThe purpose of this study is to assess a potential association between FSH levels and testicular volumes with the severity of testicular histopathology on testicular biopsy in men with non-obstructive azoospermia (NOA) undergoing microdissection testicular sperm extraction (microTESE).MethodsA retrospective chart review was performed from the electronic health records of men who underwent microTESE with NOA.ResultsEighty-six men with NOA underwent microTESE with concomitant testicular biopsy for permanent section to assess the testicular cellular architecture. The histopathological patterns were categorized by severity indicating the odds of sperm retrieval into 2 categories. The unfavorable category included Sertoli cell only pattern and early maturation arrest (n = 50) and the favorable category included late maturation arrest and hypospermatogenesis patterns (n = 36). In the men with unfavorable histopathologic patterns, the mean FSH level was 22.9 ± 16.6 IU/L, and the mean testicular volume was 10.4 ± 6.0 cc. This was in comparison to men with favorable histopathologic patterns revealing a mean FSH level of FSH 13.3 ± 12.0 with a mean testicular volume of 13.3 ± 5.9 cc. There was a statistically significant higher FSH level in men with unfavorable histopathology than favorable (p = 0.004) as well as a significant smaller mean testicular volume in men with unfavorable histopathology (p = 0.029).ConclusionsHigher serum FSH levels and smaller testicular volumes are associated with more severe testicular histopathological patterns in men with NOA.

MRI-Targeted or Standard Biopsy in Prostate Cancer Screening

BackgroundHigh rates of overdiagnosis are a critical barrier to organized prostate cancer screening. Magnetic resonance imaging (MRI) with targeted biopsy has shown the potential to address this challenge, but the implications of its use in the context of organized prostate cancer screening are unknown.MethodsWe conducted a population-based noninferiority trial of prostate cancer screening in which men 50 to 74 years of age from the general population were invited by mail to participate; participants with prostate-specific antigen (PSA) levels of 3 ng per milliliter or higher were randomly assigned, in a 2:3 ratio, to undergo a standard biopsy (standard biopsy group) or to undergo MRI, with targeted and standard biopsy if the MRI results suggested prostate cancer (experimental biopsy group). The primary outcome was the proportion of men in the intention-to-treat population in whom clinically significant cancer (Gleason score ≥7) was diagnosed. A key secondary outcome was the detection of clinically insignificant cancers (Gleason score 6).ResultsOf 12,750 men enrolled, 1532 had PSA levels of 3 ng per milliliter or higher and were randomly assigned to undergo biopsy: 603 were assigned to the standard biopsy group and 929 to the experimental biopsy group. In the intention-to-treat analysis, clinically significant cancer was diagnosed in 192 men (21%) in the experimental biopsy group, as compared with 106 men (18%) in the standard biopsy group (difference, 3 percentage points; 95% confidence interval [CI], −1 to 7; P<0.001 for noninferiority). The percentage of clinically insignificant cancers was lower in the experimental biopsy group than in the standard biopsy group (4% [41 participants] vs. 12% [73 participants]; difference, −8 percentage points; 95% CI, −11 to −5).ConclusionsMRI with targeted and standard biopsy in men with MRI results suggestive of prostate cancer was noninferior to standard biopsy for detecting clinically significant prostate cancer in a population-based screening-by-invitation trial and resulted in less detection of clinically insignificant cancer. (Funded by the Swedish Research Council and others; STHLM3-MRI ClinicalTrials.gov number, NCT03377881.)

LBA02-09 A HIGH THROUGH-PUT TEST INTERROGATING 442 SMALL NON-CODING RNAS (SNCRNA) EXTRACTED FROM URINE EXOSOMES ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW-, INTERMEDIATE- OR HIGH-RISK DISEASE

You have accessJournal of UrologyLate-breaking Abstract II - Malignant1 Sep 2021LBA02-09 A HIGH THROUGH-PUT TEST INTERROGATING 442 SMALL NON-CODING RNAS (SNCRNA) EXTRACTED FROM URINE EXOSOMES ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW-, INTERMEDIATE- OR HIGH-RISK DISEASE Laurence Klotz, Carl Olsson, Deepak Kapoor, Ann Anderson, Frederico Corica, Alberto Corica, San Juan, Puerto Rico, James Libby, Martin Tenniswood, Rebecca Devaux, Greg DiRienzo, and Winnie Wang Laurence KlotzLaurence Klotz More articles by this author , Carl OlssonCarl Olsson More articles by this author , Deepak KapoorDeepak Kapoor More articles by this author , Ann AndersonAnn Anderson More articles by this author , Frederico CoricaFrederico Corica More articles by this author , Alberto CoricaAlberto Corica More articles by this author , San JuanSan Juan More articles by this author , Puerto RicoPuerto Rico More articles by this author , James LibbyJames Libby More articles by this author , Martin TenniswoodMartin Tenniswood More articles by this author , Rebecca DevauxRebecca Devaux More articles by this author , Greg DiRienzoGreg DiRienzo More articles by this author , and Winnie WangWinnie Wang More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002149.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The miR Sentinel® PCC4 Test measures the expressions of 442 small non-coding RNAs (sncRNAs) extracted from urinary exosomes to differentiate patients with no molecular evidence of prostate cancer (NMEPC) from those with molecular evidence of prostate cancer (MEPC). The test further classifies men with MEPC into low-, intermediate- or high-risk disease. We compared the results of the miR Sentinel® PCC4 Test to systematic core needle biopsy in men presenting with initial suspicion of prostate cancer. METHODS: A total of 444 men over 45 years of age, scheduled for their first core needle biopsy, were recruited to the study. sncRNAs were isolated from urinary exosomes and interrogated by RT-PCR on a custom designed OpenArray platform to provide the molecular classifications of “NMEPC” or low-, intermediate- or high-risk prostate cancer. RESULTS: The molecular classification was compared to the Gleason Grade Group (GG). Sensitivity and Specificity for the classification of {NPEPC or GG1} versus {GG2-5} was 130/132=98% and 300/312=96% respectively. The concordance between the two methods is shown on the diagonal below as 413/444=93%. The false-negatives of the Test are the lower-left discordances (5/444=1%), whereas the apparent false-positives correspond to the upper-right discordances (26/444=6%). The term ‘apparent’ alludes to the known false negative rate of systematic biopsy for significant cancer, which may account for some of the false positive test results. Negative and positive predictive values of the Test for NMEPC versus MEPC were 97% (164/169) and 92% (253/275), respectively. CONCLUSIONS: The miR Sentinel® PCC4 Test appears to offer an accurate non-invasive means to accurately identify the presence or absence of prostate cancer and predict pathological grade on biopsy. Source of Funding: The study was funded by miRScientific © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1178-e1179 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence Klotz More articles by this author Carl Olsson More articles by this author Deepak Kapoor More articles by this author Ann Anderson More articles by this author Frederico Corica More articles by this author Alberto Corica More articles by this author San Juan More articles by this author Puerto Rico More articles by this author James Libby More articles by this author Martin Tenniswood More articles by this author Rebecca Devaux More articles by this author Greg DiRienzo More articles by this author Winnie Wang More articles by this author Expand All Advertisement Loading ...

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 ...

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.

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.