Predictive clinical features for negative histopathology of MRI/ Ultrasound-fusion-guided prostate biopsy in patients with high likelihood of cancer at prostate MRI: Analysis from a urologic outpatient clinic1

2020 ◽  
pp. 1-9
Author(s):  
Maria Apfelbeck ◽  
Paulo Pfitzinger ◽  
Robert Bischoff ◽  
Lukas Rath ◽  
Alexander Buchner ◽  
...  
Keyword(s):  
Clinical Features ◽  
Prostate Biopsy ◽  
Prostate Volume ◽  
Transitional Zone ◽  
Multivariate Logistic Regression Model ◽  
Operating Characteristics ◽  
Index Lesion ◽  
Negative Biopsy ◽  
Systematic Prostate Biopsy ◽  
Negative Outcome

OBJECTIVE: The aim of this study was to evaluate clinical features associated with benign histopathology of falsely classified Prostate Imaging Reporting and Data System (PI-RADS) category 4 and 5 lesions. MATERIALS AND METHODS: Between March 2015 and November 2020, 1161 patients underwent mpMRI/Ultrasound-fusion-guided prostate biopsy (FBx) and concurrent 12-core systematic prostate biopsy (SBx) at the Department of Urology of the Ludwig-Maximilian-University of Munich, Germany. 848/ 1161 (73%) patients presented with either PI-RADS 4 or 5 index lesion and were retrospectively evaluated. Multivariate analysis was performed to evaluate clinical parameters associated with a negative outcome of PI-RADS 4 or 5 category lesions after FBx. Area under the receiver operating characteristics (ROC) curve (AUC) was conducted using ROC-analysis. RESULTS: 676/848 (79.7%) patients with either PI-RADS 4 or 5 index lesion were diagnosed with prostate cancer (PCa) by FBx and 172/848 (20.3%) patients had a negative biopsy (including the concurrent systematic prostate biopsy), respectively. Prostate volume (P-Vol) (OR 0.99, 95% CI = 0.98–1.00, p = 0.038), pre-biopsy-status (OR 0.48, 95% CI = 0.29–0.79, p = 0.004) and localization of the lesion in the transitional zone (OR 0.28, 95% CI = 0.13–0.60, p = 0.001) were independent risk factors for a negative outcome of FBx. Age (OR 1.09, 95% CI = 1.05–1.13, p < 0.001) and PSA density (PSAD) (OR 75.92, 95% CI = 1.03–5584.61, p = 0.048) increased the risk for PCa diagnosis after FBx. The multivariate logistic regression model combining all clinical characteristics achieved an AUC of 0.802 (95% CI = 0.765–0.835; p < 0.001) with a sensitivity and specificity of 66% and 85%. CONCLUSION: Falsely positive described lesions with high or highly likelihood of PCa on multiparametric magnetic resonance imaging (mpMRI) occur in a small amount of patients. Localization of the lesion in the transitional zone, prostate volume and prebiopsy were shown to be predictors for benign histopathology of category 4 or 5 lesions on mpMRI. Integration of these features into daily clinical routine could be used for risk-stratification of these patients after negative biopsy of PI-RADS 4 or 5 index lesions.

scholarly journals PSA Density Help to Identify Patients With Elevated PSA Due to Prostate Cancer Rather Than Intraprostatic Inflammation: A Prospective Single Center Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Salvatore M. Bruno ◽  
Ugo G. Falagario ◽  
Nicola d’Altilia ◽  
Marco Recchia ◽  
Vito Mancini ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Prostate Volume ◽  
Multivariable Analysis ◽  
Binary Logistic Regression Analysis ◽  
Single Center ◽  
Negative Biopsy ◽  
Psa Density ◽  
Clinically Significant ◽  
Prostatic Inflammation

The association between PSA density, prostate cancer (PCa) and BPH is well established. The aim of the present study was to establish whether PSA density can be used as a reliable parameter to predict csPCa and to determine its optimal cutoff to exclude increased PSA levels due to intraprostatic inflammation. This is a large prospective single-center, observational study evaluating the role of PSA density in the discrimination between intraprostatic inflammation and clinically significant PCa (csPCa). Patients with PSA ≥ 4 ng/ml and/or positive digito-rectal examination (DRE) and scheduled for prostate biopsy were enrolled. Prostatic inflammation (PI) was assessed and graded using the Irani Scores. Multivariable binary logistic regression analysis was used to assess if PSA density was associated with clinically significant PCa (csPCa) rather than prostatic inflammation. A total of 1988 patients met the inclusion criteria. Any PCa and csPCa rates were 47% and 24% respectively. In the group without csPCa, patients with prostatic inflammation had a higher PSA (6.0 vs 5.0 ng/ml; p=0.0003), higher prostate volume (58 vs 52 cc; p&lt;0.0001), were more likely to have a previous negative biopsy (29% vs 21%; p=0.0005) and a negative DRE (70% vs 65%; p=0.023) but no difference in PSA density (0.1 vs 0.11; p=0.2). Conversely in the group with csPCa, patients with prostatic inflammation had a higher prostate volume (43 vs 40 cc; p=0.007) but no difference in the other clinical parameters. At multivariable analysis adjusting for age, biopsy history, DRE and prostate volume, PSA density emerged as a strong predictor of csPCA but was not associated with prostatic inflammation. The optimal cutoffs of PSA density to diagnose csPCa and rule out the presence of prostatic inflammation in patients with an elevated PSA (&gt;4 ng/ml) were 0.10 ng/ml2 in biopsy naïve patients and 0.15 ng/ml2 in patients with a previous negative biopsy. PSA density rather than PSA, should be used to evaluate patients at risk of prostate cancer who may need additional testing or prostate biopsy. This readily available parameter can potentially identify men who do not have PCa but have an elevated PSA secondary to benign conditions.

scholarly journals Importance of prostate volume for detection of prostate cancer by first sextant biopsy in high-risk patients

Medicina ◽  
2007 ◽  
Vol 43 (4) ◽  
pp. 285 ◽  
Author(s):  
Kęstutis Vaičiūnas ◽  
Stasys Auškalnis ◽  
Aivaras Matjošaitis ◽  
Darius Trumbeckas ◽  
Mindaugas Jievaltas
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Transition Zone ◽  
Prostate Biopsy ◽  
Prostate Volume ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Transitional Zone ◽  
Antigen Level ◽  
Sextant Biopsy

The aim of this study was to evaluate the relevance of prostate gland volume, transitional zone volume, and transitional zone index for the detection of prostate cancer by the first sextant biopsy. Material and methods. A total of 121 men with high risk of prostate cancer were included in our study (prostate-specific antigen level higher than 4 ng/mL and/or pathological digital rectal examination). We consulted the patients in Outpatient Department of Kaunas University of Medicine Hospital during 2003–2006. Total prostate volume and transition zone volume were measured, and all patients underwent transrectal ultrasoundguided sextant biopsy of the prostate. According to histological results of prostate biopsy, patients were divided into two groups: benign group (benign prostate hyperplasia and high-grade intraepithelial neoplasia) and prostate cancer group. Statistical analysis was made by SPSS (Statistical Package for Social Sciences) 12.0.1 for Windows. Results. After histological examination, prostate cancer was detected in 20.7% of patients (n=25). Prostate cancer was found in 24.6% of patients with a total prostate volume of less than 60 cm3 and only in 8.2% of patients with a total prostate volume greater than 60 cm3 (P=0.026). Prostate cancer was found in 27.1% of patients with transition zone volume smaller than 30 cm3 and only in 7.5% of patients with transition zone volume greater than 30 cm3 (P=0.007). A statistically significant difference was found when patients were divided into the groups according to transition zone index: when transition zone index was lower than 0.45, prostate cancer was detected in 37.1% of patients, and when transition zone index was higher than 0.45, prostate cancer was observed in 9.1% of patients (P=0.001). The possibility to detect prostate cancer was 5.9 times higher in patients with transition zone index lower than 0.45. Conclusions. Prostate cancer detection rate by first sextant prostate biopsy in patients with elevated prostate-specific antigen level and/or pathological digital rectal examination was higher when total prostate volume was less than 60 cm3, transition zone was less than 30 cm3, and transition zone index was less than 0.45.

scholarly journals MRI/US fusion prostate biopsy: Our initial experience

2016 ◽  
Vol 88 (4) ◽  
pp. 296 ◽  
Author(s):  
Vito Lacetera ◽  
Bernardo Cervelli ◽  
Antonio Cicetti ◽  
Giuliana Gabrielloni ◽  
Michele Montesi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Detection Rate ◽  
Prostate Volume ◽  
Initial Experience ◽  
Fusion Biopsy ◽  
Negative Biopsy ◽  
Group A ◽  
Group B ◽  
Target Biopsy

Aim: The objective of this study is to present our initial experience with magnetic resonance imaging/ultrasound (MRI/US) fusion biopsy using the Koelis Trinity device after the first consecutive 59 patients. Materials and methods: 59 consecutive patients with suspected prostate cancer (PCA) underwent prostate biopsy using Trinity Koelis® (Koelis, Grenoble, France). We divided the patients into 2 groups: patients with a previous negative mapping underwent to a MRI/US fusion re-biopsy (Group A); and biopsy-naïve patients who underwent to a first stereotactic 3-D mapping of the prostate (Group B). Group A (22 patients):mean age 64 years (CI 48-73), mean PSA = 7.7 ng/ml (CI 4.2- 9.9); mean prostate volume 55 ml(CI 45-82), Digital Rectal Examination (DRE) positive in 2/22, number of lesions detected by MRI 1.4, mean cores from each MRI target lesion 3 (CI 2-5), mean total cores 15 ( CI 12-19). Group B (37 patients): mean age 66 years (CI 49-77), mean PSA= 4.7 (3.2- 7.9); mean prostate volume 45 ml (33-67), DRE positive in 5/37, mean total cores 14 ( CI 10-16) Results: In Group A 10/22 patients were positive for PCA (overall detection rate of 45.5%): 6 PCA were detected by target biopsy and 4 cancer by random biopsy. Significant prostate cancer (defined as the presence of Gleason pattern 4) was detected in 4/10 patients (Significant PCA detection rate of 40%) and all significant PCA were detected by MRI target biopsy. All PCA detected by random biopsy had Gleason score 3 + 3 = 6. In Group B (biopsy naïve patients) 14/37 patients were positive for PCA (overall detection rate of 37.8%), Significant prostate cancer was detected in 5/14 patients (Significant PCA detection rate of 35,7%). No significant side effects were recorded. Conclusions: Our overall detection rate was 45.5% and 37.8% in Group A (patients with previous negative biopsy and persistent suspicion of PCA) and in Group B (biopsy naïve patients) respectively; clinical significant PCA detection rate was respectively 40% and 35.7%. These results are similar to current literature and promising for the future. We believe that using platforms of co-registered MRI/US fusion biopsy can potentially improve risk stratification and reduces understaging, undergrading and the need for repeat biopsies in biopsy naïve patients (using a stereotactic first mapping) and in patients with previous negative biopsy and persistent suspicion of PCA ( using a second MRI/US fusion biopsy).

scholarly journals  A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Repeat Biopsy ◽  
Superior Performance ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

scholarly journals A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Repeat Biopsy ◽  
Superior Performance ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

Prostate Volume Index Stratified Prostate Cancer Risk in Patients Elected to a First Random Biopsy Set

2017 ◽  
Vol 103 (4) ◽  
pp. 374-379 ◽  
Author(s):  
Antonio B. Porcaro ◽  
Paolo Corsi ◽  
Nicolò de Luyk ◽  
Marco Sebben ◽  
Alessandro Tafuri ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Goodness Of Fit ◽  
Prostate Volume ◽  
Digital Rectal Examination ◽  
Prostate Cancer Risk ◽  
Peripheral Zone ◽  
Transitional Zone ◽  
Volume Index ◽  
Multivariate Logistic Regression Model ◽  
Random Biopsy

Objective To investigate prostate volume index (PVI), defined as the ratio of volume of the transitional zone on that of the peripheral zone, as a factor stratifying prostate cancer (PCA) risk in patients elected to a first random biopsy set. Methods The study evaluated 596 patients who were elected to a first random biopsy set because of suspected PCA in a period between September 2010 and September 2015. Prostate volume index was dichotomized to PVI ≤1 vs PVI >1. The multivariate logistic regression model investigated clinical factors with dichotomized PVI associating with PCA. Results The detection rate of PCA was 49%. The dichotomized PVI >1 stratified PCA risk (odds ratio [OR] 0.455; p<0.0001) beyond age (OR 1.062; p<0.0001), PSA (OR 1.167; p<0.0001), PV (OR 0.957; p<0.0001), and abnormal digital rectal examination (OR 2.094; p<0.0001). The goodness of fit statistics assessed model efficacy. Conclusions A large cohort of patients elected to a first random biopsy set had PCA risk stratified by dichotomized PVI beyond other clinical independent factors. Confirmatory studies are required.

scholarly journals A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Repeat Biopsy ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract Background : Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate (IntelliScore) , or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods : As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results.Results : 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. Conclusions : The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

1498: The Number of Cores Needed for Prostate Biopsy Depends on Prostate Volume and Age: Evaluation of the Vienna Nomogram

2005 ◽  
Vol 173 (4S) ◽  
pp. 406-406
Author(s):  
Mesut Remzi ◽  
Yan K. Fong ◽  
Michael Dobrovits ◽  
Theodore Anagnostou ◽  
Christian Seitz ◽  
...  
Keyword(s):  
Prostate Biopsy ◽  
Prostate Volume

scholarly journals Is PSA density of the peripheral zone as a useful predictor for prostate cancer in patients with gray zone PSA levels?

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jaegeun Lee ◽  
Seung Woo Yang ◽  
Long Jin ◽  
Chung Lyul Lee ◽  
Ji Yong Lee ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Diagnosis ◽  
Prostate Biopsy ◽  
Peripheral Zone ◽  
Transitional Zone ◽  
Gray Zone ◽  
Prostate Cancer Diagnosis ◽  
Psa Density ◽  
Diagnosis Group ◽  
Predictive Rate

Abstract Background Serum prostate-specific antigen (PSA) is widely used in screening tests for prostate cancer. As the low specificity of PSA results in unnecessary and invasive prostate biopsies, we evaluated the clinical significance of various PSAs and PSA density (PSAD) related to peripheral zones in patients with gray zone PSA level (4–10 ng/mL). Methods A total of 1300 patients underwent transrectal ultrasonography-guided prostate biopsy from 2014 to 2019. Among them, 545 patients in the gray zone were divided into the prostate cancer diagnosis group and the non-prostate cancer diagnosis group, and PSA, relative extra transitional zone PSA (RETzPSA), estimated post holmium laser enucleation of the prostate PSA (EPHPSA), PSAD, peripheral zone PSA density (PZPSAD) and extra-transitional zone density (ETzD) were compared and analyzed using receiver-operating characteristics (ROC) analysis after 1:1 matching using propensity score. Results Area under the ROC curve values of PSA, EPHPSA, RETzPSA, PSA density, ETzD, and PZPSAD were 0.553 (95% CI: 0.495–0.610), 0.611 (95% CI: 0.554–0.666), 0.673 (95% CI: 0.617–0.725), 0.745 (95% CI: 0.693–0.793), 0.731 (95% CI: 0.677–0.780) and 0.677 (95% CI: 0.611–0.719), respectively. PSAD had 67.11% sensitivity, 71.71% specificity, and 70.34% positive predictive rate at 0.18 ng/mL/cc. ETzD had 69.08% sensitivity, 64.47% specificity, and 66.04% positive predictive rate at 0.04 ng/mL/cc. When the cut-off value of PSAD was increased to 0.18 ng/mL/cc, the best results were obtained with an odds ratio of 5.171 (95% CI: 3.171–8.432), followed by ETzD with 4.054 (95% CI: 2.513–6.540). Conclusions These results suggested that volume-adjusted parameters (ETzD and PSAD) might be more sensitive and accurate than various PSA in gray zone patients who required prostate biopsy to reduce unnecessary biopsy.

MP48-05 ASSESSMENT OF TUMOUR AGGRESSIVENESS IN TRANPERINEAL MRI/ULTRASOUND-FUSION BIOPSY IN COMPARISON TO TRANSRECTAL SYSTEMATIC PROSTATE BIOPSY

2015 ◽  
Vol 193 (4S) ◽  
Author(s):  
Angelika Borkowetz ◽  
Stefan Zastrow ◽  
Ivan Platzek ◽  
Marieta Toma ◽  
Michael Froehner ◽  
...  
Keyword(s):  
Prostate Biopsy ◽  
Fusion Biopsy ◽  
Systematic Prostate Biopsy
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