Underwent Prostate Biopsy Research Articles

Added value of amide proton transfer-weighted magnetic resonance imaging to Prostate Imaging Reporting and Data System version 2.1 in differentiating clinically significant prostate cancer.

Amide proton transfer-weighted magnetic resonance imaging (APTw-MRI) and apparent diffusion coefficient (ADC) values can effectively differentiate clinically significant prostate cancer (csPCa). However, their added value in Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v. 2.1) remains uncertain. This study aimed to investigate the added value of APTw-MRI and ADC to PI-RADS v. 2.1 in differentiating csPCa. This study included 161 participants who underwent prostate biopsy or radical prostatectomy within 1 month following MRI. Six magnetic resonance (MR) parameters [minimum APT value (APTmin), maximum APT value (APTmax), mean APT value (APTmean), minimum ADC value (ADCmin), maximum ADC value (ADCmax), and mean ADC value (ADCmean)] and the PI-RADS score were acquired by two radiologists. Receiver operating characteristic (ROC) curve analysis was performed to evaluate and select parameters with the greatest performance from the APT and ADC values. Multivariate logistic regression analysis was conducted to construct models based on selected MR parameters and the PI-RADS score. The Delong test was applied to compare the area under the ROC curve (AUC) between models. The lesions of csPCa exhibited higher APT values and lower ADC values than not clinically significant prostate cancer (ncsPCa). The greatest comprehensive performance in differentiating csPCa was achieved by APTmean (AUC: 0.723; cutoff value: >1.644) and ADCmean (AUC: 0.759; cutoff value: <0.656). The addition of APTmean significantly improved the performance of the model based on the PI-RADS score (AUC: APT PI-RADS 0.867 vs. PI-RADS 0.813; P=0.002). The introduction of ADCmean further improved the performance of the model based on APTmean and PI-RADS (AUC: combined model 0.875 vs. PI-RADS 0.867, P=0.69), and it retained high diagnostic efficacy (AUC: 0.835) in the validation cohort. Further verification through calibration curve and decision curve analysis demonstrated that the adjusted PI-RADS model exhibited remarkable precision and practicality. APTw-MRI and ADC are valuable parameters for differentiating csPCa and can provide additional value for improving the efficiency and clinical benefit of PI-RADS v. 2.1.

A Machine Learning Model for Prostate Cancer Prediction in Korean Men

Purpose: Unnecessary prostate biopsies for detecting prostate cancer (PCa) should be minimized. Therefore, this study developed a machine learning (ML) model to predict PCa in Korean men and evaluated its usability.Materials and Methods: We retrospectively analyzed clinical data from 928 patients who underwent prostate biopsies at Kangwon National University Hospital between May 2013 and May 2023. Of these, 377 (41.6%) were diagnosed with PCa, and 551 (59.4%) did not have cancer. For external validation, clinical data from 385 patients aged 48–89 years who underwent prostate biopsies from September 2005 to September 2023 at Wonju Severance Christian Hospital were also included. Twenty-two clinical features were used to develop an ML model to predict PCa. Features were selected based on their contributions to model performance, leading to the inclusion of 15 features. A meta-learner was constructed using logistic regression to predict the probability of PCa, and the classifier was trained and validated on randomly extracted training and test sets at an 8:2 ratio.Results: The prostate health index, prostate volume, age, nodule on digital rectal examination, and prostate-specific antigen were the top 5 features for predicting PCa. The area under the receiver operating characteristic curve (AUC) of the meta-learner logistic regression model was 0.89, and the accuracy, sensitivity, and specificity were 0.828, 0.711, and 0.909, respectively. Our model also showed excellent prediction performance for high-grade PCa, with a Gleason score of 7 or higher and an AUC of 0.903. Furthermore, we evaluated the performance of the model using external cohort clinical data and achieved an AUC of 0.863.Conclusions: Our ML model excelled in predicting PCa, specifically clinically significant PCa. Although extensive cross-validation in other clinical cohorts is needed, this ML model is a promising option for future diagnostics.

Tumor characteristics, treatments, and oncological outcomes of prostate cancer in men aged ≤60 years: real-world data from a single urological center over a 10-year period.

Prostate cancer (PCa) has emerged as one of the most common malignancies among men globally. However, its pathogenesis, clinical features, and treatment responses in younger patients (aged 60 years or below) remain underexplored. This study aims to evaluate the distinctive clinical features, treatment strategies, and oncological outcomes of PCa in men aged 60 years or younger over a 10-year period at a single urological center. We retrospectively analyzed data from The Second Hospital of Tianjin Medical University, spanning January 2010 to June 2020. The study included patients aged ≤60 years who underwent prostate biopsies. We examined clinical characteristics, pathological findings, treatment approaches, and survival outcomes using t-tests and chi-square tests. Adjusted linear regression models evaluated the relationships between treatment modalities and outcomes, while Kaplan-Meier survival analysis and Cox regression assessed progression-free survival (PFS), cancer-specific survival (CSS), and overall survival (OS). Of the 5,686 patients who underwent prostate biopsy, 643 (11.3%) were ≤60 years old. Among these, 42.8% (275/643) were diagnosed with PCa, with 59.6% presenting at advanced stages. Compared to those with negative pathology, patients with PCa were older and more likely to have hypertension, alcohol consumption, and metabolic syndrome. Most patients (69.8%) received definitive local therapy, while 22.2% opted for palliative care and 8.0% were loss to follow-up. The median follow-up period for the entire cohort was 28.0 months and the median PFS was 77.0 months. For patients receiving definitive local therapy, the median CSS and OS were not reached, while those undergoing palliative therapy had median CSS and OS of 52.0 and 59.0 months, respectively. Multivariable analysis identified prostate-specific antigen >20 ng/mL, International Society of Urological Pathology >3, bone metastasis, and localized treatment as independent factors affecting PFS. Propensity score matching showed that definitive therapy led to superior PFS compared to palliative therapy for patients with localized PCa and a life expectancy of over 5 years. Our findings highlight the influence of incidence, diagnostic characteristics, and treatment methods in younger men with PCa, emphasizing the need to identify specific risk factors and treatment response patterns. Further large-scale, multi-center research is necessary to improve diagnosis and outcomes for PCa patients in this age group.

The Comparative Study on the Application Value of Transperineal Prostate Combined Biopsy and Transrectal Prostate Systematic Biopsy in Diagnosing Prostate Cancer in Patients with Different PSA Zones.

This study aimed to compare the effects of transperineal prostate combined biopsy (TP-CB) and transrectal prostate systematic biopsy (TR-SB) on the detection rate and safety of prostate cancer in patients with prostate-specific antigen (PSA) gray zone, PSA levels of 10~20 ng/mL, and 20~40 ng/mL, and explore the comparative value of their applications. We collected 243 samples from patients with PSA ≤ 40 ng/mL who underwent prostate biopsy. All patients were divided into two groups according to different patterns of prostate biopsy. The detection rates of prostate cancer and clinically significant prostate cancer (CsPCa) in patients with PSA levels of 4~10, 10~20, and 20~40 ng/mL were compared between two different biopsy methods, surgical conditions, and the incidence of complications. The rate of a positive prostate cancer biopsy was significantly higher in TP-CB than in TR-SB (P < 0.05). Further subgroup analyses revealed no statistical significance in the rate of positive prostate cancer biopsy in patients with PSA levels of 4~10 and 20~40 ng/mL between the two groups (P > 0.05). However, patients with PSA levels of 10~20 ng/mL in the TP-CB group exhibited a higher detection rate (P < 0.05), with CsPCa accounting for a higher proportion. The TP-CB and TR-SB groups did not exhibit a significant difference in surgical conditions or overall complication rates (P > 0.05). However, the TR-SB group exhibited a higher risk of postoperative febrile infection than the TP-CB group (P < 0.05). For patients with PSA in the 'sub-gray zone' (10~20 ng/mL), TP-CB has a better diagnostic and application value and is more suitable for clinical promotion.

Proportion of Gleason Score ≥8 Prostate Cancer on Biopsy and Tumor Aggressiveness in Matched Cohorts of East Asian and Non-East Asian Men.

Historically, Asia had a lower prostate cancer (PCa) incidence and mortality compared with Western countries, but the gap is narrowing. Paradoxically, Asians have been reported to present with more advanced disease though more favorable outcomes. Despite PCa becoming an emerging health priority in East Asia, our knowledge remains limited. We compared the prevalence of high-grade PCa on biopsy and disease progression after radical prostatectomy (RP) in East Asian men from Asia and non-East Asian men from Western countries. This retrospective cohort study included men who underwent prostate biopsy and RP at academic centers in Shanghai, China, and Toronto, Canada (2014-2019). The expanded RP cohort included East Asian men from Singapore (n=282) and non-East Asians from Paris (n=192). Primary endpoints included the proportion of men with Gleason score (GS) ≥8 on biopsy and metastasis-free survival (MFS) after RP for GS ≥8. Multivariable logistic regression and Cox proportional hazard models were performed. Propensity score matching was used to reduce imbalances between cohorts. PCa was found on biopsy in 2,343 of 4,905 (48%) East Asians and 2,317 of 3,482 (67%) non-East Asians (P<.001). Prostate-specific antigen (PSA) levels at presentation and the proportion of men with GS ≥8 were higher in East Asians than non-East Asians (12.4 vs 6.6 ng/mL and 15.0% vs 8.8%, respectively; both P<.001). On multivariable analysis, there was no difference in the proportion of men with GS ≥8 between matched cohorts with PSA <20 ng/mL (n=3,572; odds ratio, 1.05 [95% CI, 0.77-1.43]; P=.76). No difference in MFS was found after RP between matched cohorts (hazard ratio, 0.97 [95% CI, 0.55-1.70]; P=.92). This contemporary study demonstrates that East Asian men are equally as likely to harbor aggressive PCa on biopsy as non-East Asian men at PSA levels observed in screening programs, with no difference in disease aggressiveness after RP. The assumption that unfavorable PCa at diagnosis is more common but less aggressive in East Asians should be revisited and viewed in the context of the expected increase in the PCa burden worldwide.

Single-dose vs prolonged antibiotic prophylaxis of fosfomycin for transrectal prostate biopsy: a single-center prospective, randomized, controlled trial

BackgroundTransrectal prostate biopsy is a commonly performed urological procedure in which antibiotic prophylaxis is recommended. Fluoroquinolone-type antibiotics are no longer acceptable in the EU. Fosfomycin-trometamol may be used, but there is no evidence regarding its ideal dose and administration time. MethodsPatients who underwent prostate biopsy between 2021 and 2023 were evaluated prospectively. 204 patients were randomized into two arms: 102 patients (Arm A) received a single-dose of fosfomycin-trometamol one hour before surgery, and 102 patients (Arm B) received one additional dose of fosfomycin-trometamol 48 hours after the first dose. Urine tests and questionnaires were administered during the postoperative period and the subsequent four weeks to identify any symptoms, infectious, or other complications. ResultsThere was no statistical difference in the rate of asymptomatic bacteriuria (4.90% (5) vs. 8.82% (9), P = 0.27) symptomatic urinary tract infection (0% (0) vs. 1.96% (2), P = 0.50), or febrile urinary tract infection (0% (0) vs. 0.98% (1), P = 1) between the groups. Only hematuria was significantly more common in Arm B (6.86% (7) vs. 16.67% (17), P = 0.03), whereas other complications did not differ significantly. There was no statistical difference in hospitalization (0.98% (1) vs. 2.94 (3), P = 0.62) or mortality rate (0 % (0) vs. 0.98% (1), P = 1). Sub-group analysis of previous antibiotic users showed no difference in terms of complications. ConclusionThere is no significant difference in infectious complications between single-dose and prolonged prophylaxis of fosfomycin-trometamol for transrectal prostate biopsy. A single-dose of fosfomycin one hour before biopsy is an ideal choice with a better ecological impact compared with prolonged antibiotic prophylaxis for transrectal prostate biopsy.

A Novel Machine Learning-Based Predictive Model of Clinically Significant Prostate Cancer and Online Risk Calculator

ObjectivesTo create a machine learning predictive model combining PI-RADS score, PSA density, and clinical variables to predict clinically significant prostate cancer (csPCa). MethodsWe evaluated a cohort of patients who underwent prostate biopsy for suspected prostate cancer (PCa) in New Zealand, Australia, and Switzerland. We collected data on age, body mass index (BMI), PSA level, prostate volume, PSA density (PSAD), PI-RADS scores, previous biopsy, and corresponding histology results. The dataset was divided into derivation (training) and validation (test) sets using random splits. An independent dataset was obtained from the Harvard Dataverse for external validation. A cohort of 1272 patients was analyzed. We fitted a Lasso model, XGBoost, and LightGBM to the training set and assessed their accuracy. ResultsAll models demonstrated ROC AUC values ranging from 0.830 to 0.851. LightGBM was considered the superior model, with an ROC of 0.851 [95%CI: 0.804 – 0.897] in the test set and 0.818 [95% CI: 0.798 – 0.831] in the external dataset. The most important variable was PI-RADS, followed by PSA density, history of previous biopsy, age, and BMI. ConclusionsWe developed a predictive model for detecting csPCa that exhibited a high ROC-AUC value for internal and external validations. This suggests that the integration of the clinical parameters outperformed each individual predictor. Additionally, the model demonstrated good calibration metrics, indicative of a more balanced model than the existing models.

Assessing the predictive value of intraductal carcinoma of the prostate (IDC-P) in determining abiraterone efficacy for metastatic hormone-sensitive prostate cancer (mHSPC) patients.

This study explored the value of intraductal carcinoma of the prostate (IDC-P) in predicting the efficacy of abiraterone treatment in metastatic hormone-sensitive prostate cancer (mHSPC) patients. A retrospective study of 925 patients who underwent prostate biopsies to detect IDC-P was conducted, with participants divided into two cohorts. The first cohort of 165 mHSPC patients receiving abiraterone treatment was analyzed to compare therapeutic effectiveness between IDC-P positive and negative cases. Utilizing propensity score matching (PSM) to reduce bias, outcomes such as PSA response, progression-free survival (PSA-PFS), radiographic progression-free survival (rPFS), and overall survival were assessed. Additionally, the second cohort of 760 mHSPC patients compared the efficacy of abiraterone with conventional hormone therapy, focusing on differences between IDC-P positive and negative individuals. After PSM, our first cohort included 108 patients with similar baseline characteristics. Among them, 50% (54/108) were diagnosed with IDC-P, with 22.2% (12/54) having IDC-P pattern 1 and 77.8% (42/54) with IDC-P pattern 2. While no notable difference was seen in PSA responses between IDC-P positive and negative patients, IDC-P presence linked to worse clinical outcomes (PSA-PFS: 18.6 months vs. not reached [NR], p = 0.009; rPFS: 23.6 months vs. NR, p = 0.020). Further analysis showed comparable outcomes for IDC-P pattern 1 but significantly worse prognosis for IDC-P pattern 2 (PSA-PFS: 18.6 months vs. NR, p = 0.002; rPFS: 22.4 months vs. NR, p = 0.010). Subgroup analysis revealed IDC-P pattern 2 consistently predicted poorer outcomes across patient subgroups. Remarkably, both IDC-P positive and negative patients gained more from androgen deprivation therapy with abiraterone than conventional treatment, with IDC-P negative patients showing a more significant survival advantage, supported by better hazard ratios (0.47 and 0.66). This study found that IDC-P, especially pattern 2, predicts poor prognosis in mHSPC patients on abiraterone therapy. Also, abiraterone's advantage over hormone therapy is reduced in cases with IDC-P compared to those without.

Clinical value of a radiomics model based on machine learning for the prediction of prostate cancer.

Radiomics models have demonstrated good performance for the diagnosis and evaluation of prostate cancer (PCa). However, there are currently no validated imaging models that can predict PCa or clinically significant prostate cancer (csPCa). Therefore, we aimed to identify the best such models for the prediction of PCa and csPCa. We performed a retrospective study of 942 patients with suspected PCa before they underwent prostate biopsy. MRI data were collected to manually segment suspicious regions of the tumor layer-by-layer. We then constructed models using the extracted imaging features. Finally, the clinical value of the models was evaluated. A diffusion-weighted imaging (DWI) plus apparent diffusion coefficient (ADC) random-forest model and a T2-weighted imaging plus ADC and DWI multilayer perceptron model were the best models for the prediction of PCa and csPCa, respectively. Areas under the curve (AUCs) of 0.942 and 0.999, respectively, were obtained for a training set. Internal validation yielded AUCs of 0.894 and 0.605, and external validation yielded AUCs of 0.732 and 0.623. Models based on machine learning comprising radiomic features and clinical indicators showed good predictive efficiency for PCa and csPCa. These findings demonstrate the utility of radiomic models for clinical decision-making.

Unlocking Precision Enhancing Prostate Cancer Detection and Reducing Unnecessary Biopsies with Combined Prostate-Specific Antigen Density and PI-RADS Score.

To determine clinically significant prostate cancer (csPCa) detection rate by combining the prostate-specific antigen density (PSAD) and prostate imaging-reporting and data system (PI-RADS) scores. Descriptive study. Place and Duration of the Study: Department of Urology, University of Health Sciences, Ankara Oncology Training and Research Hospital, from January 2018 to April 2023. Patients who underwent prostate biopsies after multiparametric magnetic resonance imaging (mpMRI) were included in the study. PI-RADS 4 and 5 lesions were considered as MR positive. The cut-off values for PSAD were also determined to evaluate csPCa. csPCa detection rates were evaluated by grouping the patients based on the PSAD and mpMRI findings. PSAD cut-off value of 0.165 ng/mL/mL (sensitivity 80%, specificity 72%) was detected to predict csPCa (AUC = 0.81, 95% CI:0.756-0.866, p<0.001). csPCa detection rate was low (3%) in patients who have low PI-RADS scores (1-3) and a PSAD <0.165 ng/mL/mL. On the other hand, csPCa detection rate was high (50.5%) in patients who have a high PI-RADS score (4-5 lesions) and with a PSAD ≥0.165 ng/mL/mL. csPCa detection rates are low in patients with PI-RADS 1-3 lesions and low PSAD values. Unnecessary biopsy may be avoided in these patients. Gleason score, PI-RADS, Prostate cancer, Prostate-specific antigen, Prostate-specific antigen density.

Abstract A039: Joint roles of proteomics and neighborhood-level social determinants of metastatic prostate cancer

Abstract Introduction: Striking racial disparities in prostate cancer (PCa) outcomes among American Black men warrant significant efforts to identify early predictors of lethal PCa, to avoid over- treatment of clinically favorable disease with minimal risk of progression. Building on prior work, this study examined independent and joint roles of proteomic markers and social determinants of health (SDOHs) in predicting prostate disease aggressiveness in a racially diverse cohort of men undergoing prostate biopsy. Methodology: A retrospective cohort of 300 men biopsied for prostate cancer was assembled at University Hospitals (UH) Seidman Cancer Center in Cleveland, Ohio between January 1, 2005-May 2022. An extensive medical chart review was performed to identify Black and White men undergoing transrectal ultrasound- guided biopsy that resulted in: (i) a negative biopsy in patients with a history of 1+ prior negative biopsy and no PCa history (“NEG”); (ii) a biopsy-detected PCa of Gleason sum 6 (“GL6”); and (iii) biopsy-detected PCa with nodal and/or distant metastases at initial cancer detection (“METS”). Prostate biopsy tissues were obtained on each patient, balancing 100 men per biopsy group, and balanced on race (1:1) within each biopsy group. Informed by findings from an untargeted analysis of the entire proteome of 60 patients (“Discovery cohort”), we conducted a targeted proteomics analysis of 16 protein markers generated from prostate biopsy tissue, using mass spectrometry, on n=240 patients (“Verification cohort”). Chi-square testing and Analysis of Variance (ANOVA) were used to assess associations between protein expression, neighborhood-level SDOHs, and biopsy group. Race-stratified analyses were performed to examine statistical interactions between study associations. Principal components (PC) analysis was used to identify protein markers that predicted the greatest variance in biopsy group. Multivariable logistic regression (MLR) was used to predict METS (vs. NEG and GL6, combined), as a function of PC-selected protein markers and census block-group level area deprivation index (ADI). Bonferroni correction was used to establish the threshold for the decision rule of statistical significance (alpha error 0.05/16 markers: p&amp;lt; 0.0031). Results: Median patient age was 68 years. Protein expression distributions were transformed into quintiles due to non-normality. Of 16 protein markers, 14 were significantly correlated with biopsy group, including PARP 1 and TGFB1, for which METS patients had the highest expression. ADI was strongly correlated with race but not protein expression. ADI was significantly higher in METS patients, followed by GL6 and lowest in NEG group; however no associations were seen for ADI with protein expression. Eight proteins were found to predict METS in PC and MLR analysis. Conclusions: These data support use of proteomics markers to predict a metastatic versus non-metastatic biopsy result. Next steps include deep exploration of proteome findings generated in the Discovery cohort, such as biological pathways. Citation Format: Jennifer Cullen, Tao Liu, Holly Hartman, Fangzhou Liu, Anood Alfahmy, Rini Ghosh, Ayesha Shafi, Julia Payne, Randy Vince, Lee Ponsky, Gregory MacLennan. Joint roles of proteomics and neighborhood-level social determinants of metastatic prostate cancer [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A039.

Clinical relevance of urinary 8‑hydroxydeoxyguanosine levels in patients undergoing prostate biopsy.

Urinary 8-hydroxydeoxyguanosine (8-OHdG) level is an oxidative stress marker in patients with cancer; however, little is currently known about the clinical relevance of urinary 8-OHdG levels in patients with prostate cancer at diagnosis. Voided urine samples were collected from patients at the time of prostate biopsy and stored at -80˚C after centrifugation. All of the patients were classified according to histology of the biopsy. Once the patients were diagnosed with prostate cancer, the standard of care and treatments were administered according to the standard guidelines. The association between clinicopathological parameters and urinary 8-OHdG and N-terminal telopeptide (NTx) levels were explored. A total of 409 patients received prostate biopsy, of which 190 were benign, 41 were diagnosed with prostatitis and 178 were diagnosed with prostate cancer. The urinary 8-OHdG/creatinine ratio was marginally associated with prostate size (P=0.052) but not with serum prostate-specific antigen levels (P=0.707). With correction for prostate size, the ratio of urinary 8-OHdG/creatinine was significantly higher in patients with prostate cancer than those without malignancy (P=0.004). Moreover, urinary 8-OHdG levels were weakly associated with urinary NTx levels (r2=0.04, P=0.009). In conclusion, urinary 8-OHdG levels normalized for prostate volume may reflect prostate cancer risk and could be used to predict prostate cancer aggressiveness.

Management considerations and treatment outcomes for newly diagnosed prostate cancer in advanced age patients (≥80 years): real-world data from a single urological center over a 10-year period.

There is ongoing debate regarding prostate cancer (PCa) screening in advanced age males, leading to treatment decisions often based on tumor staging and life expectancy. A critical gap in clinical evidence and tailored guidelines for the advanced age with PCa persists. This study aims to compare survival outcomes of various treatment approaches in this demographic. We analyzed data from a large urological center for advanced age patients suspected of having PCa between 2012 and 2022. We collected clinical and pathological characteristics and evaluated treatment modalities, including palliative therapy and definitive therapy. Propensity score matching (PSM) analysis was implemented to reduce bias between treatment modalities. Kaplan-Meier and multivariate Cox proportional hazard regression analyses were conducted to evaluate progression-free survival (PFS), cancer-specific survival (CSS), and overall survival (OS). Out of 4,333 suspected patients, 376 individuals aged 80 years and older underwent prostate biopsy. The overall detection rate of PCa was 78.7%, with a high prevalence of high-grade tumors [International Society of Urological Pathology (ISUP) grade ≥2]. Most patients (86.5%) received palliative therapy, while 13.5% underwent definitive therapy. Patients in the definitive therapy group had lower prostate-specific antigen (PSA) values, lower tumor stage, and Charlson Comorbidity Index (CCI), longer life expectancy, and a higher Geriatric 8 (G8) score compared to the palliative therapy group. The median OS for the entire cohort was 72.0 months, with 70.0 months for palliative therapy and 96.0 months for definitive therapy. Multivariable analyses identified lymphatic and bone metastasis, as well as definitive therapy, as independent prognostic factors for PFS, CSS, and OS. Advanced age patients, although a small group, have distinct characteristics, including higher PSA levels, positive biopsy rates, and pathological grading and staging. In medically fit elderly patients, especially those with localized PCa and a life expectancy of ≥5 years, definitive therapy could improve survival outcomes.

Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial.

Asian, Black, and Hispanic men are underrepresented in prostate cancer (PCa) clinical trials. Few novel prostate cancer biomarkers have been validated in diverse cohorts. We aimed to determine if Stockholm3 can improve prostate cancer detection in a diverse cohort. An observational prospective multicentered (17 sites) clinical trial (2019-2023), supplemented by prospectively recruited participants (2008-2020) in a urology clinic setting included men with suspicion of PCa and underwent prostate biopsy. Before biopsy, sample was collected for measurement of the Stockholm3 risk score. Parameters include prostate-specific antigen (PSA), free PSA, KLK2, GDF15, PSP94, germline risk (single-nucleotide polymorphisms), age, family history, and previous negative biopsy. The primary endpoint was detection of International Society of Urological Pathology (ISUP) Grade ≥2 cancer (clinically significant PCa, csPC). The two primary aims were to (1) demonstrate noninferior sensitivity (0.8 lower bound 95% CI noninferiority margin) in detecting csPC using Stockholm3 compared with PSA (relative sensitivity) and (2) demonstrate superior specificity by reducing biopsies with benign results or low-grade cancers (relative specificity). A total of 2,129 biopsied participants were included: Asian (16%, 350), Black or African American (Black; 24%, 505), Hispanic or Latino and White (Hispanic; 14%, 305), and non-Hispanic or non-Latino and White (White; 46%, 969). Overall, Stockholm3 showed noninferior sensitivity compared with PSA ≥4 ng/mL (relative sensitivity: 0.95 [95% CI, 0.92 to 0.99]) and nearly three times higher specificity (relative specificity: 2.91 [95% CI, 2.63 to 3.22]). Results were consistent across racial and ethnic subgroups: noninferior sensitivity (0.91-0.98) and superior specificity (2.51-4.70). Compared with PSA, Stockholm3 could reduce benign and ISUP 1 biopsies by 45% overall and between 42% and 52% across racial and ethnic subgroups. In a substantially diverse population, Stockholm3 significantly reduces unnecessary prostate biopsies while maintaining a similar sensitivity to PSA in detecting csPC.

Clinical value of ultrasound-guided full-needle path anesthesia in transperineal prostate biopsy: An observational study.

The pain sensation in a transperineal prostate biopsy was obvious. This study explored the clinical value of ultrasound-guided full-needle path anesthesia in transperineal prostate biopsy. Two hundred patients who underwent ultrasound-guided transperineal prostate biopsy at our department were randomly divided into 2 groups. The control group received routine local infiltration anesthesia, and the experimental group received ultrasound-guided full-needle path anesthesia. Immediately after biopsy, visual analog scoring was used to evaluate pain during the biopsy process. Seven days postbiopsy, telephone follow-up revealed symptoms, such as hematuria and discomfort during urination. The measured data were expressed as x ± s. The 2 groups were compared using the t test, and the differences were statistically significant (P < .05). There were no significant differences in age, prostate-specific antigen (PSA) level, or prostate volume between the 2 groups, and all patients underwent prostate biopsy. The pain score of visual analog score was (2.55 ± 0.88), urination discomfort was (1.86 ± 0.67) days and hematuria time was (2.87 ± 0.91) days in the experimental group after biopsy. In the control group, the pain score of visual analog scale was (4.32 ± 0.94), the urination discomfort was (2.3 ± 0.77) days, and the hematuria time was (2.85 ± 0.83) days. Pain scores and urination discomfort were compared between the 2 groups (P < .01). Pain and urination discomfort associated with prostate biopsy in the experimental group were significantly lower than those in the control group. Ultrasound-guided full needle path anesthesia can alleviate pain sensation in patients undergoing transperineal prostate biopsy and has high clinical value.

ProsTAV, a clinically useful test in prostate cancer: an extension study

PurposeTo assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa).MethodsPreliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3–10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center’s routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined.ResultsThe mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85–0.95) and specificity of 0.27 (95% CI, 0.19–0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46–0.60) and 0.74 (95% CI, 0.62–0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI.ConclusionsProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.

A 2-year prospective evaluation of the Prostate Health Index in guiding biopsy decisions in a large cohort.

To prospectively evaluate how the Prostate Health Index (PHI) impacts on clinical decision in a real-life setting for men with a prostate-specific antigen (PSA) level between 4 and 10 ng/mL and normal digital rectal examination. Since 2016, the PHI has been available at no cost to eligible men in all Hong Kong public hospitals. All eligible patients who received PHI testing in all public Urology units (n = 16) in Hong Kong between May 2016 and August 2017 were prospectively included and followed up. All included men had a PHI test, with its result and implications explained; the subsequent follow-up plan was then decided via shared decision-making with urologists. Patients were followed up for 2 years, with outcomes including prostate biopsy rates and biopsy findings analysed in relation to the initial PHI measurements. A total of 2828 patients were followed up for 2 years. The majority (82%) had PHI results in the lower risk range (score <35). Knowing the PHI findings, 83% of the patients with elevated PSA decided not to undergo biopsy. In all, 11% and 45% opted for biopsy in the PHI score <35 and ≥35 groups, respectively. The initial detection rate of International Society of Urological Pathology (ISUP) Grade Group (GG) ≥2 cancer was higher in the PHI score ≥35 group (23%) than in the PHI score <35 group (7.9%). Amongst patients with no initial positive biopsy findings, the subsequent positive biopsy rate for ISUP GG ≥2 cancer was higher in the PHI score ≥35 group (34%) than the PHI score <35 group (13%) with a median follow-up of 2.4 years. In a real-life setting, with the PHI incorporated into the routine clinical pathway, 83% of the patients with elevated PSA level decided not to undergo prostate biopsy. The PHI pathway also improved the high-grade prostate cancer detection rate when compared to PSA-driven strategies. Higher baseline PHI predicted subsequent biopsy outcome at 2 years. The PHI can serve as a tool to individualise biopsy decisions and frequency of follow-up visits.

Diagnostic properties of percent-free PSA as a predictor of prostate cancer in Thai men with total serum PSA level of 4-10 ng/ml

Objective: The percent-free prostate specific antigen (%fPSA) could enhance total PSA (tPSA) with regards to early prostate cancer detection by increasing its specificity. However, due to significant physiologic differences across races, the optimal cut-off level for %fPSA may vary. We aimed to determine optimal %fPSA cut-off level for Thai men aged between 50 to 80 years whose tPSA score ranged from 4-10 ng/mL and to evaluate its corresponding diagnostic properties, specifically sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). The secondary endpoint is the relationship between Gleason Grade Group and %fPSA value. Materials and Methods: A total of 184 male patients from age 50-80 years whose tPSA was between 4-10 ng/ml were enrolled onto the study. Their %fPSA were measured before undergoing transrectal ultrasonography (TRUS) guided prostate biopsy, which procured at least 10 cores. All histologic reports were reviewed and confirmed for further analysis. Results: Out of the 184 patients registered the final diagnoses were 31 (16.84%) were positive for prostate cancer and the other 153 (83.16%) had benign prostate hypertrophy (BPH). At %fPSA cut-off of ≤ 10%, the sensitivity would be 22.6%, specificity 95.4%, PPV 50.0% and NPV 85.9%. However, at a %fPSA cut-off of ≤ 20%, the sensitivity was 77.4%, specificity 32.7%, PPV 18.9%, and NPV 87.7%. The %fPSA value has a direct relationship with sensitivity and NPV whereas it is inversely proportional to specificity and PPV. Lower %fPSA is associated with higher risk of prostate cancer. The area under the curve (AUC) of ROC curve was 0.65. The incidence of prostate cancer among patients with Gleason Grade Groups 1, 2, 3, 4, and 5 were 41.94%, 32.26%, 16.13%, 6.45%, and 3.23% respectively. The mean %fPSA scores among those groups were 14.75%, 17.64%, 10.19% ,13.33%, and 15.65% respectively. Conclusion: The decision to undergo prostate biopsy in Thai males with a tPSA score between 4-10 ng/ml can be guided by %fPSA, which proved to be an effective and useful predictive tool. The cut-off level of %fPSA ≤ 20% had the highest diagnostic properties in Thai men in our study which yielded a sensitivity of 77.4%, specificity of 32.7%, PPV of 18.9%, and NPV 87.7%. If %fPSA was ≥ 30%, there was no risk of prostate cancer in this cohort. In addition, with regard to disease severity, we found that %fPSA level is not associated with the Gleason Grade Grouping.

Natural history of histologically benign PIRADS 4-5 lesions in multiparametric MRI: Real-life experience in an academic center.

The follow-up findings of patients who underwent prostate biopsy for prostate image reporting and data system (PIRADS) 4 or 5 multiparametric magnetic resonance imaging (mpMRI) findings and had benign histology were retrospectively reviewed. There were 190 biopsy-naive patients. Patients with at least 12 months of follow-up between 2012 and 2023 were evaluated. All MRIs were interpreted by two very experienced uroradiologists. Of the patients, 125 had either cognitive or software fusion MR-targeted biopsies with 4 + 8/10 cores. The remaining 65 patients had in-bore biopsies with 4-5 cores. Prostate-specific antigen (PSA) levels below 4 ng/mL were defined as PSA regression following biopsy. PIRADS 1-3 lesions on new MRI images were classified as MRI regression. Median patient age and PSA were 62 (39-82) years and six (0.4-33) ng/mL, respectively, at the initial work-up. During a median follow-up period of 44 months, 37 (19.4%) patients were lost to follow-up. Of the remaining 153 patients, 82 (53.6%) had persistently high PSA. Among them, 72 (87.8%) had repeat mpMRI within 6-24 months which showed regressive findings (PIRADS 1-3) in 53 patients (73.6%) and PIRADS 4-5 index lesion persistence in 19 cases (26.4%). The latter group was recommended to have rebiopsy. Of these 19 patients, 16 underwent MRI-targeted rebiopsy. Prostate cancer was diagnosed in six (37.5%) patients and of these four (25%) were clinically significant (>Grade Group 1). Totally, clinically significant prostate cancer was detected in 4/153 (2.6%) patients followed up. Patients should be warned against the relative relaxing effect of a negative biopsy after identification of PIRADS 4-5 index lesion. While PSA decrease was observed in many patients during follow-up, persistent MRI findings were present in nearly a quarter of patients with persistently high PSA. A rebiopsy is warranted in these patients, with significant prostate cancer diagnosed in a quarter of patients with rebiopsy.

The effectiveness of mapping-targeted biopsies on the index lesion in transperineal prostate biopsies.

To evaluate the effectiveness of mapping-targeted biopsies (MTB) on the index lesion for the detection of clinically significant prostate cancer (csPCa) in transperineal fusion-image prostate biopsies. A retrospective analysis was conducted on 309 men with suspected PCa who underwent prostate biopsies at the Creu Blanca reference center in Barcelona, Spain. The Prostate Imaging-Reporting and Data System (PI-RADS v.2.1) of the magnetic resonance images (MRI) were reclassified by an expert radiologist reading of pre-biopsy biparametric MRI used for segmentation of suspected lesions. Transperineal MTB of suspicious lesions and 12-core systematic biopsies were performed using the Artemis™ platform. CsPCa was defined as International Society of Urological Pathology grade group ≥ 2. CsPCa was detected in 192 men (62.1%), with detection rates of 6.3% for PI-RADS 2, 26.8% for PI-RADS 3, 87.3% for PI-RADS 4, and 93.1% for PI-RADS 5. MTB of the index lesion identified 185 csPCa (96.3%). CsPCa was detected solely in systematic biopsies in three cases (1.6%), while an additional four cases (2.1%) were identified only in the second suspected lesion. A predictive model for csPCa detection in MTB of the index lesion was developed, with an AUC of 0.918 (95% CI 0.887-0.950). This model had the potential to avoid 23.3% of prostate biopsies without missing additional csPCa cases. MTB of the index lesion was highly effective for identifying csPCa in fusion transperineal prostate biopsies. A developed predictive model successfully reduced the need for almost one quarter of biopsies without missing csPCa cases.