Diagnostic Performance of 68Ga Prostate-specific Membrane Antigen PET/MRI Compared with Multiparametric MRI for Detecting Clinically Significant Prostate Cancer.

Objective: To analyze 68-Ga prostate-specific membrane antigen (PSMA) uptake pattern of the prostate and its correlation with prostate-specific antigen (PSA), digital rectal examination (DRE), and Gleason’s score in the diagnosis of carcinoma of the prostate (CaP). Methods: This was a retrospective study conducted between June 2015 and August 2017. Patients who had undergone whole body 68-Ga PSMA HBED-CC simultaneous positron emission tomography (PET) or magnetic resonance imaging (MRI) for the diagnosis or staging of CaP were eligible. Patients who presented with persistently raised serum PSA (>4 ng/mL) and normal urine routine and negative culture were included in the study. Results: A total of 74 patients were included in the study. Significant positive correlation was observed between PSMA delayed uptake with the Prostate Imaging Reporting and Data System (PI-RADS) score ( p<0.001, ρ=0.750), PSA level ( p<0.001, ρ=0.414), DRE ( p<0.002, ρ=0.400), and Gleason’s score ( p<0.300, ρ=0.02). There was a significant difference between early and delayed phase of PSMA uptake in malignant prostatic lesions ( p<0.001). Delayed phase of PSMA uptake was able to characterize prostate lesions with an area under curve (AUC) of 0.91. Combined receiver operating characteristic analysis of PI-RADS score derived from multiparametric MRI and differential PSMA uptake to characterize prostatic lesions improved AUC to 0.94. Conclusion: Results demonstrated that the correlation with clinicopathological features (PSA, DRE, and Gleason’s score) could be used in prognostication of prostatic lesion along with PSMA PET/MRI.

Objective: To analyze the relationship between Prostate Imaging Reporting and Data System (PI-RADS) scores and the pathological results of transperineal magnetic resonance-ultrasound fusion guided biopsy. Methods: The clinical data, magnetic resonance imaging (MRI) results and prostate puncture biopsies of 517 patients who were assigned to PI-RADS score of 4 or 5 and underwent transperineal magnetic resonance-ultrasound fusion guided biopsy at The First Affiliated Hospital of Nanjing Medical University from June 2019 to March 2022 were retrospectively analyzed. Patients were divided into the PI-RADS 4 and PI-RADS 5 groups according to their PI-RADS scores and were stratified by their prostate specific antigen (PSA) values (PSA<10 ng/ml vs. PSA 10-20 ng/ml). The pathological negative rates from the biopsy, the distribution of the grade groups according to the grading system by World Health Organization/International Society of Urological Pathology (WHO/ISUP), the detection rates of prostate cancer (PCa) and clinically significant prostate cancer (CsPCa)between the groups were compared. Results: 369 patients with a PI-RADS score of 4 and 148 patients with a PI-RADS score of 5 were included in our research. The overall detection rates of PCa and CsPCa were 77.8% (402/517) and 66.7% (345/517), respectively. In the PI-RADS 4 group, patients with prostate negative biopsies or in WHO/ISUP 1, 2, 3, 4, or 5 grade groups accounted for 28.2%, 12.7%, 20.1%, 17.1%, 18.4% and 3.5%, respectively, whereas in the PI-RADS 5 group the rates were 7.4%, 6.8%, 22.3%, 22.3%, 26.4%, and 14.9%, respectively. The difference was statistically significant (P<0.001). The detection rates of PCa and CsPCa in the PI-RADS 4 group [71.8% (265/369) vs. 59.1% (218/369), P<0.001] were lower than those of the PI-RADS 5 group [92.6% (137/148) vs. 85.8% (127/148), P<0.001]. In the PI-RADS 4 group, the proportion of patients classified into WHO/ISUP 4-5 grade groups was lower than that of patients in the PI-RADS 5 group [22.0% (81/369) vs 41.2% (61/148) (P<0.001)]. The detection rates of PCa and CsPCa in the PSA<10 ng/ml stratification were less than that in the PSA 10-20 ng/ml stratification[74.1% (281/379) vs. 87.7% (121/138), P=0.001], and [60.9% (231/379) vs. 82.6% (114/138), P<0.001]. For patients with PSA<10 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS5 group [70.9% (217/306) vs. 87.7% (64/73), P=0.003], and [56.2% (172/306) vs. 80.8% (59/73), P<0.001]. For those with a PSA value of 10-20 ng/ml, the detection rates of PCa and CsPCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group [76.2% (48/63) vs. 97.3% (73/75), P<0.001], and [73.0% (46/63) vs. 90.7% (68/75), P=0.006]. There were statistically significant differences in the proportions of patients with prostate negative biopsy and those falling into WHO/ISUP grade groups 1, 2, 3, 4, or 5 (P<0.001) between the PI-RADS 4 group and the PI-RADS 5 group in both stratifications. Conclusions: In this study, the detection rates of CsPCa and PCa in the PI-RADS 4 group were less than those in the PI-RADS 5 group. With the increase of PI-RADS scores, the detection rate of high-grade PCa increased. The same results held for patients with PSA<10 ng/ml or with PSA 10-20 ng/ml.

The Prostate Imaging Reporting and Data System (PI-RADS) score reports the likelihood of a clinically significant prostate cancer (CsPCa) based on various multiparametric prostate magnetic resonance imaging (mpMRI) characteristics. The PI-RADS category 3 is an intermediate status, with an equivocal risk of malignancy. The PSA density (PSAD) has been proposed as a tool to facilitate biopsy decisions on PI-RADS category 3 lesions. The objective of this study is to determine the frequency of CsPCa, assess the diagnostic value of targeted biopsy and identify clinical predictors to improve the CsPCa detection rate in PI-RADS category 3 lesions. Between 1st January 2017 and 31st December 2022, a total of 1661 men underwent a prostate biopsy at our institution. Clinical and mpMRI data of men with PI-RADS 3 lesions was reviewed. The study population was divided into two groups: target group, including those submitted to systematic plus targeted biopsy versus non-target group when only systematic or saturation biopsy were performed. Patients with PI-RADS 3 lesions were divided into three categories based on pathological biopsy results: benign, clinically insignificant disease (score Gleason = 6 or International Society of Urologic Pathologic (ISUP) 1) and clinically significant cancer (score Gleason ≥ 7 (3+4) or ISUP ≥ 2) according to target and non-target group. Univariate and multivariate analyses were performed to identify clinical predictors to improve the CsPCa detection rate in PI-RADS category 3 lesions. A total of 130 men with PIRADS 3 index lesions were identified. Pathologic results were benign in 77 lesions (59.2%), 19 (14.6%) were clinically insignificant (Gleason score 6) and 34 (26.2%) were clinically significant (Gleason score 7 or higher). Eighty-seven of the patients were included in the target group (66.9%) and 43 in the non-target group (33.1%). The CsPCa detection was higher in the non-target group (32.6%, n = 14 vs 23.0%, n = 20 respectively). When systematic and target biopsies were jointly performed, if the results of systematic biopsies are not considered and only the results of target biopsies are taken into account, a CsPCa diagnosis would be missed on 9 patients. The differences of insignificant cancer and CsPCa rates among the target or non-target group were not statistically significant (p = 0.50 and p = 0.24, respectively). on multivariate analysis, the abnormal DRE and lesions localized in Peripheral zone (PZ) were significantly associated with a presence of CsPCa in PI-RADS 3 lesions (oR = 3.61, 95% CI [1.22,10.72], p = 0.02 and oR = 3.31, 95% CI [1.35, 8.11], p = 0.01, respectively). A higher median PSAD significantly predisposed for CsPCa on univariate analyses (p = 0.05), however, was not significant in the multivariate analysis (p = 0.76). In our population, using 0.10 ng/ml/ml as a cut-off to perform biopsy, 41 patients would have avoided biopsy (31.5%), but 5 cases of CsPCa would not have been detected (3.4%). We could not identify any statistical significance between other clinical and imagiological variables and CsPCa detection. PI-RADS 3 lesions were associated with a low likelihood of CsPCa detection. A systematic biopsy associated or not with target biopsy is essential in PI-RADS 3 lesions, and targeted biopsy did not demonstrate to be superior in the detection of CsPCa. The presence of abnormal DRE and lesions localized in PZ potentially predict the presence of CsPCa in biopsied PI-RADS 3 lesions.

BackgroundAny non-invasive test that can predict the absence of prostate cancer (PCa) or absence of clinically significant PCa (CSPCa) is necessary, as it can reduce the number of unnecessary biopsies in patients with gray zone prostate-specific antigen (PSA, 4 - 10 ng/mL). This study evaluated the diagnostic performance of free PSA% and PSA density (PSAD), and Prostate Imaging Reporting and Data System (PIRADS) score (version 2.0) alone and combined in predicting CSPCa in patients with PSA between 4 and 10 ng/mL.MethodsThis prospective study included a total of 104 consecutive patients with lower urinary tract symptoms (LUTS) and serum PSA between 4 and 10 ng/mL, with or without abnormal digital rectal examination (DRE) findings or any hypoechoic lesion on ultrasound sonography of prostate and without prior transrectal ultrasound (TRUS) biopsy of prostate. PIRADS score was calculated using multi-parametric magnetic resonance imaging (mp-MRI) before TRUS biopsy of prostate. Relationships among PIRADS score, PSAD, free PSA% and presence of CSPCa in TRUS biopsy were statistically analyzed.ResultsIn patients with CSPCa, significantly higher median age (P = 0.001), PSA level (P < 0.001), PSAD (P < 0.001) and significantly lower prostate volume (P < 0.001) and free PSA% were observed as compared to patients with non-CSPCa. Significantly higher proportion of patients with CSPCa showed PIRADS positive test compared to those with non-CSPCa (86.4% vs. 53.3%, P < 0.001). Cut-off values for PSAD and free PSA% were 0.12 ng/mL2 and 25%, respectively. Age, PSAD and free PSA% were significant predictors of PCa, while age and PSAD were significant predictors of CSPCa. Criteria 2, 3 and 4 demonstrated higher specificity and positive predictive value (PPV) in predicting CSPCa as compared to criterion 1. The overall accuracies of criterion 1, 2, 3 and 4 were 64.42%, 85.58%, 80.77% and 79.81%, respectively. The area under the curve (AUC) values of criterion 2, 3 and 4 were higher (0.827, 0.732 and 0.792) than criterion 1 (0.665).ConclusionUsing PIRADS score for predicting CSPCa as a screening test, criteria 2, 3 and 4 have much higher diagnostic performance and present accuracy of mp-MRI to predict CSPCa can be increased with addition of PSAD and free PSA%.

Background/Objectives: Multiparametric MRI (mpMRI) and targeted biopsies have revolutionized prostate cancer (PC) detection through the Prostate Imaging Reporting and Data System (PIRADS). However, the effect of prostate volume on cancer detection and the predictive accuracy of PIRADS in the mpMRI-guided biopsy era remains unclear. The aim was to assess whether prostate volume affects detection rates of clinically significant prostate cancer (CSPC) and high-risk prostate cancer (HRPC) and modifies the predictive performance of the PIRADS score. Methods: We retrospectively analyzed 361 biopsy-naïve men who underwent mpMRI-fusion transperineal biopsies between 2016 and 2023. Lesions graded PIRADS ≥ 3 were targeted alongside systematic sampling. A receiver-operating characteristic (ROC) curve (AUC = 0.74) defined a 44 mL cutoff separating small (<44 mL; n = 160) and large (≥44 mL; n = 193) prostates. Logistic regression and cubic-spline analyses evaluated associations between prostate volume, PIRADS, and cancer outcomes. Results: Any cancer was detected in 74.3% of small versus 35.5% of large prostates (p < 0.001); CSPC in 42.5% vs. 19.6% (p < 0.001); HRPC in 14.3% vs. 5.5% (p < 0.001). Small prostate volume independently predicted any cancer (OR 7.31; 95% CI 4.22–12.7), CSPC (OR 5.08; 95% CI 2.87–8.99), and HRPC (OR 4.50; 95% CI 1.80–11.3). Between 40 and 70 mL, each 10 mL increase in volume reduced CSPC risk by 61% (p = 0.008). Prostate volume significantly modified PIRADS accuracy: in large glands, PIRADS 3 lesions carried only 2% risk for CSPC and 0% for HRPC, while in small prostates, PIRADS 3 conferred a 16.9-fold increased CSPC risk. Conclusions: Prostate volume inversely correlates with cancer detection and aggressiveness. PIRADS performance is volume-dependent; PIRADS 3 lesions in large prostates rarely represent significant cancer and may not warrant biopsy.

Background Multiparametric MRI (mpMRI) is effective for detecting prostate cancer (PCa); however, there is a high rate of equivocal Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions and false-positive findings. Purpose To investigate whether fluorine 18 (18F) prostate-specific membrane antigen (PSMA) 1007 PET/CT after mpMRI can help detect localized clinically significant PCa (csPCa), particularly for equivocal PI-RADS 3 lesions. Materials and Methods This prospective study included participants with elevated prostate-specific antigen (PSA) levels referred for prostate mpMRI between September 2020 and February 2022. 18F-PSMA-1007 PET/CT was performed within 30 days of mpMRI and before biopsy. PI-RADS category and level of suspicion (LOS) were assessed. PI-RADS 3 or higher lesions at mpMRI and/or LOS 3 or higher lesions at 18F-PSMA-1007 PET/CT underwent targeted biopsies. PI-RADS 2 or lower and LOS 2 or lower lesions were considered nonsuspicious and were monitored during a 1-year follow-up by means of PSA testing. Diagnostic accuracy was assessed, with histologic examination serving as the reference standard. International Society of Urological Pathology (ISUP) grade 2 or higher was considered csPCa. Results Seventy-five participants (median age, 67 years [range, 52-77 years]) were assessed, with PI-RADS 1 or 2, PI-RADS 3, and PI-RADS 4 or 5 groups each including 25 participants. A total of 102 lesions were identified, of which 80 were PI-RADS 3 or higher and/or LOS 3 or higher and therefore underwent targeted biopsy. The per-participant sensitivity for the detection of csPCa was 95% and 91% for mpMRI and 18F-PSMA-1007 PET/CT, respectively, with respective specificities of 45% and 62%. 18F-PSMA-1007 PET/CT was used to correctly differentiate 17 of 26 PI-RADS 3 lesions (65%), with a negative and positive predictive value of 93% and 27%, respectively, for ruling out or detecting csPCa. One additional significant and one insignificant PCa lesion (PI-RADS 1 or 2) were found at 18F-PSMA-1007 PET/CT that otherwise would have remained undetected. Two participants had ISUP 2 tumors without PSMA uptake that were missed at PET/CT. Conclusion 18F-PSMA-1007 PET/CT showed good sensitivity and moderate specificity for the detection of csPCa and ruled this out in 93% of participants with PI-RADS 3 lesions. Clinical trial registration no. NCT04487847 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Turkbey in this issue.

Introduction: Prostate cancer is a prevalent and potentially lethal malignancy affecting men worldwide. To enhance early detection and accurate risk stratification, various diagnostic methods have been developed. Prostate cancer diagnoses include a digital rectal examination, prostate-specific antigen analysis and prostate biopsy in case prostate cancer is suspected. Total prostate-specific antigen (tPSA) is a widely used, first line and acceptable biomarker for prostate cancer screening. Rising tPSA levels cannot be a definitive diagnosis for prostate cancer and further examination is needed. Мagnetic resonance imaging (MRI) is an irreplaceable part of prostate cancer diagnosis. The introduction of Prostate Imaging-Reporting and Data System (PI-RADS) in MRI of prostate gland precises the cases in which performance of target biopsy is needed by classifying suspected prostate lеsions according to the probability of detecting prostate cancer. Objectivе: The objective of this study is to assess the correlation between tPSA levels and PI-RADS scores in patients who underwent MRI of the prostate gland due to elevated tPSA levels. Material and methods: A retrospective study of 374 patients medical records was carried out from January 2019 to June 2023. All patients had tPSA over 4 ng/ml and underwent MRI. Lesions were classified according to PI-RADS v2.1. Results: Patients mean age was 67.8 ± 8.2 years. Mean prostate volume was 52.67 ± 19.6 cc. 87.5 % of the patients had a negative rectal digital exam and 12.5 % had a positive one. tPSA levels ranged from 4.10 to 500 ng/ml. Patients were categorized in four groups according to their tPSA levels: group A with tPSA levels ranging from 4 to 9.9 ng/ml; group B – tPSA from 10 to 19.9 ng/ ml; group C – tPSA from 20 to 39.9 ng/ml; group D – tPSA over 40 ng/ml. MRI and PI-RADS v2 scoring were performed in all patients. 29.4 % of the MRI exams found lesions scored as PI-RADS 3, 47.1 % – as PI-RADS 4 and 22.5 % as PI-RADS 5. There were only 3 cases of lesions categorized as PI-RADS 2 in the study. These patients did not undergo a biopsy and were followed up. 33.9 % of patients in group A were c assified with PI-RADS score 3, 52.3 % – PI-RADS score 4 and 13.8 % – PI-RADS 5. In group B 1.8 %were categorized in PI-RADS score 2, 28.9 % – PI-RADS score 3, 44.7 % were PI-RADS 4 and 24.6 % PI-RADS 5. In group C the majority of patients (47.9 % and 32.6 %) had lesions classified as PI-RADS 4 and 5. In group D most of the patients` lesions – 60.7 %, were categorized as PI-RADS 5. Conclusion: There is a significant correlation between PI-RADS score and serum total PSA levels with a tendency of higher PI-RADS scores as the tPSA level reaches 10 ng/ml. Elevation of tPSa levels over 4 ng/ml requires MRI of the prostate gland and PI-RADS classification as a diagnostic and confirmation tool for further decision making.

Simple SummaryThe newest Prostate Imaging Reporting and Data System (PI-RADS) version 2.1, was published in 2019. There are a few variations of the new standard, which will change prostate lesions’ classification rules. Our study aims to analyze the pattern change of lesion positron emission tomography (PET) standardized uptake values maximum (SUVmax) distribution under PI-RADS V2.1, compared with PI-RADS V2.0. Moreover, we studied the correlation between prostate-specific membrane antigen (PSMA) SUVmax and magnetic resonance imaging (MRI) PI-RADS. So far, there is no article reporting the effect of the newest PI-RADS on [68Ga]Ga-PSMA-11 PET/MRI. We did a thorough analysis, including two subgroups, peripheral zone, transitional zone, and 215 lesions. We analyzed the impact of each variation of PI-RADS one by one.Purpose: We aimed to evaluate the correlation between PSMA uptake and magnetic resonance imaging (MRI) PI-RADS of simultaneous [68Ga]Ga-PSMA-11 PET/MRI regarding PI-RADS version 2.0 and 2.1 respectively and compared the difference between these two versions. Materials and Methods: We retrospectively analyzed a total of forty-six patients with biopsy-proven prostate cancer who underwent simultaneous [68Ga]Ga-PSMA-11 PET/MRI. We classified the lesions regarding PI-RADS version 2.0 and 2.1, peripheral zone (PZ), and transitional zone (TZ), respectively. Based on regions of interest (ROI), standardized uptake values maximum (SUVmax), and corresponding lesion-to-background ratios (LBR) of SUVmax of each category, PI-RADS score 1 to 5, were measured. A comparison between PI-RADS version 2.0 and PI-RADS version 2.1 was performed. Results: A total of 215 focal prostate lesions were analyzed, including two subgroups, 125 TZ and 90 PZ. Data are reported as median and interquartile range (IQR). Regarding PI-RADS version 2.1, TZ SUVmax of each category were 1.5 (0.5, 1.9), 1.9 (0.8, 2.3), 3.3 (2.1, 4.6), 4.2 (3.1, 5.7), 7.3 (5.2, 9.7). PZ SUVmax of each category were 1.0 (0.8, 1.6), 2.5 (1.5, 3.2), 3.3 (1.9, 4.5), 4.3 (3.0, 5.4), 7.4 (5.0, 9.3). Regarding the inter-reader agreement of the overall PI-RADS assessment category, the kappa value was 0.723 for version 2.0 and 0.853 for version 2.1. Conclusion: Revisions of PI-RADS version 2.1 results in variations in lesions classification. Lesions with the PI-RADS category of 3, 4, and 5 present relatively higher intraprostatic PSMA uptake, while lesions with the PI-RADS category of 1 and 2 present relatively lower and similar uptake. Version 2.1 has higher inter-reader reproducibility than version 2.0.

To evaluate the effectiveness of magnetic resonance imaging/ultrasound (MRI-US)-guided fusion biopsy in the detection of clinically significant prostate cancer (CSPC) and analyze the clinical features of patients highly suspected of having prostate cancer (PCa) but shown to be negative in target biopsies (TB) among patients with prostate imaging reporting and data system (PI-RADS) 4 or 5 lesions on multiparametric MRI (mpMRI) evaluations. We retrospectively evaluated all patients who underwent MRI/transrectal ultrasound (TRUS)-guided fusion biopsies at our institution between April 2018 and April 2022. All patients with at least one PI-RADS 3 or higher lesion and prostate-specific antigen (PSA) ≤20 ng/ml were enrolled in our study and subjected to TB in the region of interest (ROI). CSPC was defined as grade group (GG) ≥2 (equivalent to a Gleason score of 3+4). The detection rates of CSPC were higher in patients who underwent systematic biopsy (SB) and TB (54%; 177/328) than in those who underwent SB alone (39%; 128/328). Significant differences were noted in the detection of CSPC depending on age, prostate volume, PI-RADS score, PSA density (PSAD), number of biopsies obtained, lesion location, and ROI. MRI/TRUS-guided fusion prostate biopsy increased the detection rate of CSPC. PCa was less likely to be detected in patients with a low PSAD, large prostate volume and no family history among those with PI-RADS 4 or 5 lesions and should be considered in such patients and addressed by performing additional SB for improving CSPC detection rate.

Invited Commentary: Changing Landscape of Imaging in Recurrent Prostate Cancer.

Background Use of multi-parametric magnetic resonance imaging (mp-MRI) and Prostate Imaging Reporting and Data System (PI-RADS) scoring system allowed more precise detection of prostate cancer (PCa). Our study aimed at evaluating the diagnostic performance of mp-MRI in detection of PCa. Methods Eighty-six patients suspected to have prostate cancer were enrolled. All patients underwent mp-MRI followed by systematic and targeted trans-rectal ultrasound (TRUS) guided prostate biopsies. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of mp-MRI were evaluated. Results Forty-six patients (53.5%) had prostate cancer on targeted and systematic TRUS biopsies. On mp-MRI, 96.6% of lesions with PI-RADS < 3 revealed to be benign by TRUS biopsy, 73.3% of lesions with PI-RADS 4 showed ISUP grades ≥1, whereas all PI-RADS 5 lesions showed high ISUP grades ≥ 3. For PI-RADS 3 lesions, 62.5% of them revealed to be benign and 37.5% showed ISUP grades ≥1 by TRUS biopsy. PI-RADS scores ˃3 had 69.57% sensitivity and 85% specificity for detection of PCa. On adding the equivocal PI-RADS 3 lesions, PI-RADS scores ≥3 had higher sensitivity (97.83%), but at the cost of lower specificity (32.5%). Conclusion Mp-MRI using PI-RADS V2 scoring system categories ≤3 and >3 could help in detection of PCa. PI-RADS 3 lesions are equivocal. Including PI-RADS lesions ≥3 demonstrated higher sensitivity, but at the cost of lower specificity for mp-MRI in diagnosis for Pca. Abbreviations CDR: cancer detection rates; DRE: digital rectal examination; ISUP: international society of urological pathology; mp-MRI: multi-parametric magnetic resonance imaging; NPV: negative predictive value; PCa: prosatate cancer; PI-RADS: Prostate Imaging Reporting and Data System; PPV: Positive predictive value; PSA: prostate specific antigen; TRUS: transrectal ultrasound.

Background. Multiparametric magnetic resonance imaging and Prostate Imaging Reporting and Data System (PI-RADS) are widely used to diagnose clinically significant prostate cancer. Meanwhile, PI-RADS diagnostic accuracy varies between 30 % for PI-RADS score 3 to 80 % for PI-RADS score 5. The value of PI-RADS scores in patients already diagnosed with prostate cancer remains unclear.Aim. To evaluate the impact of PI-RADS score on adverse surgical outcomes: prostate cancer upstaging, increased Gleason score, lymph node metastases, positive surgical margin, and oncological outcomes in patients of the ISUP grade 1 group per the International Society of Urological Pathology (ISUP) scale who underwent radical prostatectomy.Materials and methods. Forty patients with ISUP grade 1 prostate cancer underwent radical prostatectomy (robotic or laparoscopic). All patients underwent diagnostic multiparametric magnetic resonance imaging with PI-PADS score v2 (v2.1) prior to radical prostatectomy. PI-RADS 3 was determined in 14 (35 %), PI-RADS 4 – in 10 (25 %) and PI-RADS 5 – in 16 (40 %) patients, respectively. The age of patients was 62.7 ± 6.6 years. Stage cT2a was diagnosed in 19 (47.5 %), cT2b – in 5 (12.5 %), cT2c – in 11 (27.5 %), cT3a – in 5 (12.5 %) patients, respectively. Pelvic lymph node dissection was performed in 23 (57.5 %) cases. The median follow-up was 12.6 months.Results. Upstaging events to pT3a occurred in 2 (15.2 %) patients with PI-RADS 3 lesions, in 5 (31.3 %) patients with PI-RADS 5 lesions; upstaging events to pT3b occurred in 1 (10 %) patient with PI-RADS 4 lesions, and in 1 (6.25 %) patient with PI-RADS 5 lesions. Increased Gleason score (GS) was observed in 22 (55 %) patients: GS increase ≥2 was diagnosed in 8 (57.1 %) patients with PI-RADS 3 lesions, in 3 (30 %) patients with PI-RADS 4 lesions, in 11 (68.7 %) patients with PI-RADS 5 lesions, respectively. Lymph node metastases were observed only in 1 (4.3 %) patient with PI-RADS 5 lesions. Positive surgical margin (&gt;3 mm) was observed in 2 (12.4 %) patients with PI-RADS 5 lesions. Biochemical recurrence occurred in 1 (2.5 %) patient with PI-RADS 3 lesions. One-year biochemical recurrence-free survival was 97.5 %.Conclusion. Increased PI-RADS score from 3 to 5 is accompanied by increased frequency of prostate cancer upstaging and Gleason score increase in patients with ISUP grade 1 prostate cancer. PI-RADS scores 3–5 can be important in selecting patients for nerve-sparing prostatectomy, pelvic lymph node dissection, and play a part in prediction of biochemical recurrence and lymph node metastasis.

Most Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions do not contain clinically significant prostate cancer (CSPCa; grade group ≥2). This study was aimed at identifying clinical and magnetic resonance imaging (MRI)-derived risk fac- tors that predict CSPCa in men with PI-RADS 3 lesions. This study analyzed the detection of CSPCa in men who underwent MRI-targeted biopsy for PI-RADS 3 lesions. Multivariable logistic regression models with goodness-of-fit testing were used to identify variables associated with CSPCa. Receiver operating curves and decision curve analyses were used to estimate the clinical utility of a predictive model. Of the 1784 men reviewed, 1537 were included in the training cohort, and 247 were included in the validation cohort. The 309 men with CSPCa (17.3%) were older, had a higher prostate-specific antigen (PSA) density, and had a greater likelihood of an anteriorly located lesion than men without CSPCa (p < .01). Multivariable analysis revealed that PSA density (odds ratio [OR], 1.36; 95% confidence interval [CI], 1.05-1.85; p < .01), age (OR, 1.05; 95% CI, 1.02-1.07; p < .01), and a biopsy-naive status (OR, 1.83; 95% CI, 1.38-2.44) were independently associated with CSPCa. A prior negative biopsy was negatively associated (OR, 0.35; 95% CI, 0.24-0.50; p < .01). The application of the model to the validation cohort resulted in an area under the curve of 0.78. A predicted risk threshold of 12% could have prevented 25% of biopsies while detecting almost 95% of CSPCas with a sensitivity of 94% and a specificity of 34%. For PI-RADS 3 lesions, an elevated PSA density, older age, and a biopsy-naive status were associated with CSPCa, whereas a prior negative biopsy was negatively associated. A predictive model could prevent PI-RADS 3 biopsies while missing few CSPCas. Among men with an equivocal lesion (Prostate Imaging-Reporting and Data System 3) on multiparametric magnetic resonance imaging (mpMRI), those who are older, those who have a higher prostate-specific antigen density, and those who have never had a biopsy before are at higher risk for having clinically significant prostate cancer (CSPCa) on subsequent biopsy. However, men with at least one negative biopsy have a lower risk of CSPCa. A new predictive model can greatly reduce the need to biopsy equivocal lesions noted on mpMRI while missing only a few cases of CSPCa.

The objective of this investigation was to explore the diagnostic capability of Prostate Specific Antigen Mass Ratio (PSAMR) combined with Prostate Imaging Reporting and Data System (PI-RADS) scoring for clinically significant prostate cancer (CSPC), develop and validate a Nomogram prediction model for the probability of prostate cancer occurrence in patients who have not undergone prostate biopsy. Initially, we retrospectively collected clinical and pathological data of patients who underwent trans-perineal prostate puncture at Yijishan Hospital of Wanan Medical College from July 2021 to January 2023. Through logistic univariate and multivariate regression analysis, independent risk factors for CSPC were determined. Receiver Operating Characteristic (ROC) curves were generated to compare the ability of different factors for diagnosis of CSPC. Then, we split the dataset into a training set and validation set, compared their heterogeneity, and developed a Nomogram prediction model based on the training set. Finally, we validated the Nomogram prediction model in terms of discrimination, calibration, and clinical usefulness. Logistic multivariate regression analysis illustrated that age [64-69 (OR = 2.736, P = 0.029); 69-75 (OR = 4.728, P = 0.001); > 75 (OR = 11.344, P < 0.001)], PSAMR [0.44-0.73 (OR = 4.144, P = 0.028); 0.73-1.64(OR = 13.022, P < 0.001); > 1.64(OR = 50.541, P < 0.001)], and PI-RADS score [4 points (OR = 7.780, P < 0.001); 5 points (OR = 24.533, P < 0.001)] were independent risk factors for CSPC. The Area Under the Curve (AUC) of the ROC curves of PSA, PSAMR, PI-RADS score, and PSAMR combined with PI-RADS score were respectively 0.797, 0.874, 0.889, and 0.928. The performance of PSAMR and PI-RADS score for diagnosis of CSPC was superior to PSA, but inferior to PSAMR combined with PI-RADS. Age, PSAMR, and PI-RADS were included in the Nomogram prediction model. The AUCs of the training set ROC curve and the validation set ROC curve were 0.943 (95% CI 0.917-0.970) and 0.878 (95% CI 0.816-0.940), respectively, in the discrimination validation. The calibration curve showed good consistency, and the decision analysis curve suggested the model had good clinical efficacy. We found that PSAMR combined with PI-RADS scoring had a strong diagnostic capability for CSPC, and provided a Nomogram prediction model to predict the probability of prostate cancer occurrence combined with clinical data.

PurposeFor men with an elevated prostate-specific antigen (PSA), there is a strong evidence for prostate MRI to assess the risk of clinically significant prostate cancer (CSPC) and guide targeted-biopsy interventions....