Project description:To develop and validate biopsy-free nomograms to more accurately predict clinically significant prostate cancer (csPCa) in biopsy-naïve men with prostate imaging reporting and data system (PI-RADS) ≥ 4 lesions. A cohort of 931 patients with PI-RADS ≥ 4 lesions, undergoing prostate biopsies or radical prostatectomy from January 2020 to August 2023, was analyzed. Various clinical variables, including age, prostate-specific antigen (PSA) levels, prostate volume (PV), PSA density (PSAD), prostate health index (PHI), and maximum standardized uptake values (SUVmax) from PSMA PET-CT imaging, were assessed for predicting csPCa. Model performance was evaluated using area under the receiver operating characteristic curve (AUC), calibration plots, and decision-curve analyses, with internal validation. The foundational model (nomogram 1) encompassed the entire cohort, accurately predicting csPCa by incorporating variables such as age, PSAD, PV, PSA ratio variations, suspicious lesion location, and history of acute urinary retention (AUR). The AUC for csPCa prediction achieved by the foundational model was 0.918, with internal validation confirming reliability (AUC: 0.908). Advanced models (nomogram 2 and 3), incorporating PHI and PHI + PSMA SUVmax, achieved AUCs of 0.908 and 0.955 in the training set and 0.847 and 0.949 in the validation set, respectively. Decision analysis indicated enhanced biopsy outcome predictions with the advanced models. Nomogram 3 could potentially reduce biopsies by 92.41%, while missing only 1.53% of csPCa cases. In conclusion, the newly biopsy-free approaches for patients with PI-RADS ≥ 4 lesions represent a significant advancement in csPCa diagnosis in this high-risk population.
Project description:PurposeTo compare the performance of radiomics to that of the Prostate Imaging Reporting and Data System (PI-RADS) v2.1 scoring system in the detection of clinically significant prostate cancer (csPCa) based on biparametric magnetic resonance imaging (bpMRI) vs. multiparametric MRI (mpMRI).MethodsA total of 204 patients with pathological results were enrolled between January 2018 and December 2019, with 142 patients in the training cohort and 62 patients in the testing cohort. The radiomics model was compared with the PI-RADS v2.1 for the diagnosis of csPCa based on bpMRI and mpMRI by using receiver operating characteristic (ROC) curve analysis.ResultsThe radiomics model based on bpMRI and mpMRI signatures showed high predictive efficiency but with no significant differences (AUC = 0.975 vs 0.981, p=0.687 in the training cohort, and 0.953 vs 0.968, p=0.287 in the testing cohort, respectively). In addition, the radiomics model outperformed the PI-RADS v2.1 in the diagnosis of csPCa regardless of whether bpMRI (AUC = 0.975 vs. 0.871, p= 0.030 for the training cohort and AUC = 0.953 vs. 0.853, P = 0.024 for the testing cohort) or mpMRI (AUC = 0.981 vs. 0.880, p= 0.030 for the training cohort and AUC = 0.968 vs. 0.863, P = 0.016 for the testing cohort) was incorporated.ConclusionsOur study suggests the performance of bpMRI- and mpMRI-based radiomics models show no significant difference, which indicates that omitting DCE imaging in radiomics can simplify the process of analysis. Adding radiomics to PI-RADS v2.1 may improve the performance to predict csPCa.
Project description:PurposeTo develop and validate a PI-RADS-based nomogram for predicting the probability of clinically significant prostate cancer (csPCa) at initial prostate biopsy.Patients and MethodsFrom February 2015 to October 2018, 573 consecutive patients made up the development cohort (DC), and another 253 patients were included as an independent validation cohort (VC). Univariate and multivariate analysis were used for determining the dependent clinical risk factors for csPCa. Prediction model1 was constructed by integrating independent clinical risk factors. T?hen added the PI-RADS score to model1 to develop the prediction model2 and present it in the form of a nomogram. The performance of the nomogram was assessed by receiver operating characteristic curve, net reclassification improvement analysis, calibration curve, and decision curve.ResultsAll clinical candidate factors were significantly different between csPCa and non-csPCa in both the DC and VC. Age, PSA density (PSAD), and free-to-total PSA ratio (f/t) were ultimately determined as dependent clinical risk factors for csPCa and integrated into prediction model1. Then, prediction model2 was developed and presented in a nomogram. In the DC, the nomogram (AUC=0.894) was superior to model1, PI-RADS score, or other clinical factors alone in detecting csPCa. Similar result (AUC=0.891) was obtained in the VC. NRI analysis showed that the nomogram improved the classification of patients significantly compared with model1. Furthermore, the nomogram showed favorable calibration and great clinical usefulness.ConclusionThis study developed and validated a nomogram that integrates PI-RADS score with other independent clinical risk factors to facilitate prebiopsy individualized prediction in high-risk patients with csPCa.
Project description:PurposeIn this study, we aimed to validate and compare three scoring systems based on biparametric magnetic resonance imaging (bpMRI) for the detection of clinically significant prostate cancer (csPCa) in biopsy-naïve patients.MethodIn this study, we included patients who underwent MRI examinations between January 2018 and December 2022, with MRI-targeted fusion biopsy (MRGB) as the reference standard. The MRI findings were categorized using three bpMRI-based scorings, in all of them the diffusion-weighted imaging (DWI) was the dominant sequence for peripheral zone (PZ) and T2-weighed imaging (T2WI) was the dominant sequence for transition zone (TZ). We also used the Prostate Imaging Reporting and Data System version (PI-RADS) v2.1 to evaluate each lesion. For each scoring, we calculated the sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the receiver operating characteristic (ROC) curves (AUC).ResultsThe calculated AUC for three bpMRI-based scorings were 83.2% (95% CI 78.8%-87.6%), 85.0% (95% CI 80.8%-89.3%), 82.9% (95% CI 78.4%-87.5%), and 86.0% (95% CI 81.8%-90.1%), respectively. Scoring 2 exhibited significantly superior performance than scoring 1 (P = 0.01) and scoring 3 (P < 0.001). Moreover, the accuracy of scoring 2 was not decreased significantly as compared to PI-RADS v2.1 (P = 0.05). There was no significant difference between 3 bpMRI-based scorings and with PI-RADS in TZ. However, although scoring 2 yielded the highest AUC, it was still notably inferior to PI-RADS (P = 0.02).ConclusionAll three bpMRI-based scorings demonstrated favorite diagnostic accuracy, and scoring 2 performed significantly better than the other two bpMRI-based scorings. Notably, scoring 2 was not significantly inferior to the full-sequence PI-RADS v2.1 in terms of sensitivity and specificity.
Project description:PurposeTo develop and validate a radiomics nomogram for the prediction of clinically significant prostate cancer (CsPCa) in Prostate Imaging-Reporting and Data System (PI-RADS) category 3 lesions.MethodsWe retrospectively enrolled 306 patients within PI-RADS 3 lesion from January 2015 to July 2020 in institution 1; the enrolled patients were randomly divided into the training group (n = 199) and test group (n = 107). Radiomics features were extracted from T2-weighted imaging (T2WI), apparent diffusion coefficient (ADC) imaging, and dynamic contrast-enhanced (DCE) imaging. Synthetic minority oversampling technique (SMOTE) was used to address the class imbalance. The ANOVA and least absolute shrinkage and selection operator (LASSO) regression model were used for feature selection and radiomics signature building. Then, a radiomics score (Rad-score) was acquired. Combined with serum prostate-specific antigen density (PSAD) level, a multivariate logistic regression analysis was used to construct a radiomics nomogram. Receiver operating characteristic (ROC) curve analysis was used to evaluate radiomics signature and nomogram. The radiomics nomogram calibration and clinical usefulness were estimated through calibration curve and decision curve analysis (DCA). External validation was assessed, and the independent validation cohort contained 65 patients within PI-RADS 3 lesion from January 2020 to July 2021 in institution 2.ResultsA total of 75 (24.5%) and 16 (24.6%) patients had CsPCa in institution 1 and 2, respectively. The radiomics signature with SMOTE augmentation method had a higher area under the ROC curve (AUC) [0.840 (95% CI, 0.776-0.904)] than that without SMOTE method [0.730 (95% CI, 0.624-0.836), p = 0.08] in the test group and significantly increased in the external validation group [0.834 (95% CI, 0.709-0.959) vs. 0.718 (95% CI, 0.562-0.874), p = 0.017]. The radiomics nomogram showed good discrimination and calibration, with an AUC of 0.939 (95% CI, 0.913-0.965), 0.884 (95% CI, 0.831-0.937), and 0.907 (95% CI, 0.814-1) in the training, test, and external validation groups, respectively. The DCA demonstrated the clinical usefulness of radiomics nomogram.ConclusionThe radiomics nomogram that incorporates the MRI-based radiomics signature and PSAD can be conveniently used to individually predict CsPCa in patients within PI-RADS 3 lesion.
Project description:PurposeThis study aimed to develop and validate a model based on biparametric magnetic resonance imaging (bpMRI) for the detection of clinically significant prostate cancer (csPCa) in biopsy-naïve patients.MethodThis retrospective study included 324 patients who underwent bpMRI and MRI targeted fusion biopsy (MRGB) and/or systematic biopsy, of them 217 were randomly assigned to the training group and 107 were assigned to the validation group. We assessed the diagnostic performance of three bpMRI-based scorings in terms of sensitivity and specificity. Subsequently, 3 models (Model 1, Model 2, and Model 3) combining bpMRI scorings with clinical variables were constructed and compared with each other using the area under the receiver operating characteristic (ROC) curves (AUC). The statistical significance of differences among these models was evaluated using DeLong's test.ResultsIn the training group, 68 of 217 patients had pathologically proven csPCa. The sensitivity and specificity for Scoring 1 were 64.7% (95% CI 52.2%-75.9%) and 80.5% (95% CI 73.3%-86.6%); for Scoring 2 were 86.8% (95% CI 76.4%-93.8%) and 73.2% (95% CI 65.3%-80.1%); and for Scoring 3 were 61.8% (95% CI 49.2%-73.3%) and 80.5% (95% CI 73.3%-86.6%), respectively. Multivariable regression analysis revealed that scorings based on bpMRI, age, and prostate-specific antigen density (PSAD) were independent predictors of csPCa. The AUCs for the 3 models were 0.88 (95% CI 0.83-0.93), 0.90 (95% CI 0.85-0.94), and 0.88 (95% CI 0.83-0.93), respectively. Model 2 showed significantly higher performance than Model 1 (P = 0.03) and Model 3 (P < 0.01).ConclusionAll three scorings had favorite diagnostic accuracy. While in conjunction with age and PSAD the prediction power was significantly improved, and the Model 2 that based on Scoring 2 yielded the highest performance.
Project description:Background and objectiveBiparametric magnetic resonance imaging (bpMRI), excluding dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI), is a potential replacement for multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer (csPCa). An extensive international multireader multicase observer study was conducted to assess the noninferiority of bpMRI to mpMRI in csPCa diagnosis.MethodsAn observer study was conducted with 400 mpMRI examinations from four European centers, excluding examinations with prior prostate treatment or csPCa (Gleason grade [GG] ≥2) findings. Readers assessed bpMRI and mpMRI sequentially, assigning lesion-specific Prostate Imaging Reporting and Data System (PI-RADS) scores (3-5) and a patient-level suspicion score (0-100). The noninferiority of patient-level bpMRI versus mpMRI csPCa diagnosis was evaluated using the area under the receiver operating curve (AUROC) alongside the sensitivity and specificity at PI-RADS ≥3 with a 5% margin. The secondary outcomes included insignificant prostate cancer (GG1) diagnosis, diagnostic evaluations at alternative risk thresholds, decision curve analyses (DCAs), and subgroup analyses considering reader expertise. Histopathology and ≥3 yr of follow-up were used for the reference standard.Key findings and limitationsSixty-two readers (45 centers and 20 countries) participated. The prevalence of csPCa was 33% (133/400); bpMRI and mpMRI showed similar AUROC values of 0.853 (95% confidence interval [CI], 0.819-0.887) and 0.859 (95% CI, 0.826-0.893), respectively, with a noninferior difference of -0.6% (95% CI, -1.2% to 0.1%, p < 0.001). At PI-RADS ≥3, bpMRI and mpMRI had sensitivities of 88.6% (95% CI, 84.8-92.3%) and 89.4% (95% CI, 85.8-93.1%), respectively, with a noninferior difference of -0.9% (95% CI, -1.7% to 0.0%, p < 0.001), and specificities of 58.6% (95% CI, 52.3-63.1%) and 57.7% (95% CI, 52.3-63.1%), respectively, with a noninferior difference of 0.9% (95% CI, 0.0-1.8%, p < 0.001). At alternative risk thresholds, mpMRI increased sensitivity at the expense of reduced specificity. DCA demonstrated the highest net benefit for an mpMRI pathway in cancer-averse scenarios, whereas a bpMRI pathway showed greater benefit for biopsy-averse scenarios. A subgroup analysis indicated limited additional benefit of DCE MRI for nonexperts. Limitations included that biopsies were conducted based on mpMRI imaging, and reading was performed in a sequential order.Conclusions and clinical implicationsIt has been found that bpMRI is noninferior to mpMRI in csPCa diagnosis at AUROC, along with the sensitivity and specificity at PI-RADS ≥3, showing its value in individuals without prior csPCa findings and prostate treatment. Additional randomized prospective studies are required to investigate the generalizability of outcomes.
Project description:BackgroundThis study attempted to develop a nomogram for predicting clinically significant prostate cancer (cs-PCa) in the transition zone (TZ) with the Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) score based on biparametric magnetic resonance imaging (bp-MRI) and clinical indicators.MethodsWe retrospectively reviewed 383 patients with suspicious prostate lesions in the TZ as a training cohort and 128 patients as the validation cohort from January 2015 to March 2020. Multivariable logistic regression analysis was performed to determine independent predictors for building a nomogram, and the performance of the nomogram was assessed by the area under the receiver operating characteristic curve (AUC), the calibration curve and decision curve.ResultsThe PI-RADS v2.1 score and prostate-specific antigen density (PSAD) were independent predictors of TZ cs-PCa. The prediction model had a significantly higher AUC (0.936) than the individual predictors (0.914 for PI-RADS v2.1 score, P=0.045, 0.842 for PSAD, P<0.001). The nomogram showed good discrimination (AUC of 0.936 in the training cohort and 0.963 in the validation cohort) and favorable calibration. When the PI-RADS v2.1 score was combined with PSAD, the diagnostic sensitivity and specificity were 80.7% and 93.8%, respectively, which were better than those of the PI-RADS v2.1 score (sensitivity, 74.2%; specificity, 92.5%) and PSAD (sensitivity, 66.1%; specificity, 88.2%).ConclusionsThe newly constructed nomogram exhibits satisfactory predictive accuracy and consistency for TZ cs-PCa. PI-RADS v2.1 based on bp-MRI is a strong predictor in the detection of TZ cs-PCa. Adding PSAD to PI-RADS v2.1 could improve its diagnostic performance, thereby avoiding unnecessary biopsies.
Project description:ObjectiveTo develop and internally validate nomograms based on multiparametric magnetic resonance imaging (mpMRI) to predict prostate cancer (PCa) and clinically significant prostate cancer (csPCa) in patients with a previous negative prostate biopsy.Materials and methodsThe clinicopathological parameters of 231 patients who underwent a repeat systematic prostate biopsy and mpMRI were reviewed. Based on Prostate Imaging and Reporting Data System, the mpMRI results were assigned into three groups: Groups "negative," "suspicious," and "positive." Two clinical nomograms for predicting the probabilities of PCa and csPCa were constructed. The performances of nomograms were assessed using area under the receiver operating characteristic curves (AUCs), calibrations, and decision curve analysis.ResultsThe median PSA was 15.03 ng/ml and abnormal DRE was presented in 14.3% of patients in the entire cohort. PCa was detected in 75 patients (32.5%), and 59 (25.5%) were diagnosed with csPCa. In multivariate analysis, age, prostate-specific antigen (PSA), prostate volume (PV), digital rectal examination (DRE), and mpMRI finding were significantly independent predictors for PCa and csPCa (all p < 0.01). Of those patients diagnosed with PCa or csPCa, 20/75 (26.7%) and 18/59 (30.5%) had abnormal DRE finding, respectively. Two mpMRI-based nomograms with super predictive accuracy were constructed (AUCs = 0.878 and 0.927, p < 0.001), and both exhibited excellent calibration. Decision curve analysis also demonstrated a high net benefit across a wide range of probability thresholds.ConclusionmpMRI combined with age, PSA, PV, and DRE can help predict the probability of PCa and csPCa in patients who underwent a repeat systematic prostate biopsy after a previous negative biopsy. The two nomograms may aid the decision-making process in men with prior benign histology before the performance of repeat prostate biopsy.
Project description:ObjectiveTo evaluate the complementary value of urinary MyProstateScore (MPS) testing and multiparametric MRI (mpMRI) and assess outcomes in patients with equivocal mpMRI.Materials and methodsIncluded patients underwent mpMRI followed by urine collection and prostate biopsy at the University of Michigan between 2015 -2019. MPS values were calculated from urine specimens using the validated model based on serum PSA, urinary PCA3, and urinary TMPRSS2:ERG. In the PI-RADS 3 population, the discriminative accuracy of PSA, PSAD, and MPS for GG≥2 cancer was quantified by the AUC curve. Decision curve analysis was used to assess net benefit of MPS relative to PSAD.ResultsThere were 540 patients that underwent mpMRI and biopsy with MPS available. The prevalence of GG≥2 cancer was 13% for PI-RADS 3, 56% for PI-RADS 4, and 87% for PI-RADS 5. MPS was significantly higher in men with GG≥2 cancer [median 44.9, IQR (29.4 -57.5)] than those with negative or GG1 biopsy [median 29.2, IQR (14.8 -44.2); P <.001] in the overall population and when stratified by PI-RADS score. In the PI-RADS 3 population (n = 121), the AUC for predicting GG≥2 cancer was 0.55 for PSA, 0.62 for PSAD, and 0.73 for MPS. MPS provided the highest net clinical benefit across all pertinent threshold probabilities.ConclusionIn patients that underwent mpMRI and biopsy, MPS was significantly associated with GG≥2 cancer across all PI-RADS scores. In the PI-RADS 3 population, MPS significantly outperformed PSAD in ruling out GG≥2 cancer. These findings suggest a complementary role of MPS testing in patients that have undergone mpMRI.