Risk of false conformity decisions due to measurement uncertainty of Active Pharmaceutical Ingredient: A multiparametric evaluation

Abstract Medicines must be subject to physical, chemical, and biological analysis to guarantee their quality, safety, and effectiveness. Despite the efforts to ensure the reliability of analytical results, some uncertainty will always be associated with the measured value, which can lead to false decisions regarding conformity/non-conformity assessment. This work aims to calculate the specific risk of false decisions regarding conformity/non-conformity of acetaminophen oral solution dosage form. The acetaminophen samples from five different manufacturers (A, B, C, D, and E) were subject to an active pharmaceutical ingredient assay, density test, and dose per drop test according to the official compendia. Based on measured values and their respective uncertainties, the risk values were calculated using the Monte Carlo method implemented in an MS Excel spreadsheet. The results for two acetaminophen oral solution samples (C and D) provided an increased total risk value of false acceptance (33.1% and 9.6% for C and D, respectively). On the other hand, the results for the other three acetaminophen samples (A, B, and E) provided a negligible risk of false acceptance (0.004%, 0.025%, and 0.045% for A, B, and E, respectively). This indicates that measurement uncertainty is very relevant when a conformity assessment is carried out, and information on the risks of false decisions is essential to ensure proper decisions.

Diagnóstico por imágenes de un síndrome de Wernicke Korsakoff con estigmas de Marchiafava-Bignami / maging diagnosis of Wernicke - Korsakoff syndrome with Marchiafava-Bignami stigmat

Las enfermedades de Marchiafava-Bignami y de Wernicke Korsakoff, se consideran complicaciones neuropsiquiátricas causadas por el consumo crónico de bebidas alcohólicas. Son encefalopatías poco frecuentes caracterizadas por una desmielinización y necrosis del cuerpo calloso, con la subsiguiente atrofia por daño en las partes bajas del cerebro (tálamo e hipotálamo). Se presenta un paciente masculino de 29 años, con antecedentes de alcoholismo, el cual acude a consulta de Oftalmología por presentar disminución de la visión del ojo derecho durante un año. Se le realizaron, tomografía simple y resonancia magnética con contraste endovenoso de cráneo, donde se observaron hallazgos radiológicos compatibles con el síndrome de Wernicke Korsakoff (ocasiona afectación de la memoria y el aprendizaje) con estigmas de Marchiafava-Bignami (enfermedad poco conocida). Es necesario el dominio de la epistemología de estas enfermedades, porque, a pesar del mal pronóstico en su forma aguda, se reportan casos con buena evolución, si se le realiza un diagnóstico y tratamiento oportunos.

Marchiafava-Bignami and Wernicke-Korsakoff diseases are considered neuropsychiatric complications caused by the chronic consumption of alcoholic beverages. They are rare encephalopathies characterized by demyelination and necrosis of the corpus callosum, with subsequent atrophy due to damage in the lower parts of the brain (thalamus and hypothalamus). We present a 29-year-old male patient with a history of alcoholism who went to the Ophthalmology consultation due to decreased vision in his right eye for a year. Simple tomography and magnetic resonance imaging with intravenous contrast of the skull were performed, observing radiological findings of Wernicke -Korsakoff syndrome (affect memory and learning) with Marchiafava-Bignami stigmata (little-known disease). Mastery of the epistemology of these diseases is necessary, because, despite the poor prognosis in its acute form, cases with good evolution are reported, if an opportune diagnosis and treatment is made.

Value of multiparametric ultrasonography in the differential diagnosis of benign and malignant testicular lesions / 中华超声影像学杂志

Objective:To explore the value of multiparametric ultrasonography consisting of gray-scale ultrasound(US), color Doppler flow imaging (CDFI), real-time strain elastography(RTE), and contrast-enhanced ultrasound(CEUS) in the differential diagnosis of testicular lesions.Methods:Forty patients (40 lesions) detected by ultrasonography examination at the Ultrasound Medical Center of Lanzhou University Second Hospital from June 2020 to June 2022 were retrospectively analyzed, and further the CDFI, CEUS and RTE were performed. The presence of vascularization in the lesion was determined by CDFI and CEUS, avascular lesions were defined as benign, vascularization lesions were defined as malignant. The lesion tissue elasticity was assessed by real-time strain elastography, tissue stiffness was encoded as red(soft), green(intermediate), and blue(hard), and the hard lesions were defined as malignant, soft lesions were defined as benign. All lesions were subjected to pathological histologic examination after surgical resection or puncture biopsy as a reference standard. The correct classification rate, sensitivity, specificity and likelihood ratio of the multiparametric ultrasonography imaging for the diagnosis of benign and malignant testicular lesions were analyzed by ROC.Results:Of 40 testicular lesions, 24 (60.0%) were benign and 16 (40.0%) were malignant. The sensitivity of CDFI, CEUS and RTE in the diagnosis of testicular lesions was 0.875, 1.000 and 1.000, and the specificity was 0.833, 0.750 and 0.708, respectively. The correct classification rate was 85.0%, 85.0% and 82.5%, and the positive likelihood ratio was 5.24, 4.00 and 4.42, respectively. AUC was 0.781, 0.802, 0.771, respectively. By combining RTE and CDFI, a sensitivity of 1.000 and specificity of 0.875 and correct classification rate of 92.8% and positive likelihood ratio of 8.00 and AUC of 0.915 ( P<0.001) were achieved in differentiating testicular lesions. And combining RTE and CEUS, achieved sensitivity of 1.000 and specificity of 0.917 and correct classification rate of 95.0% and positive likelihood ratio of 12.0 and AUC of 0.958( P<0.001). Conclusions:Multiparametric US is of great value in the differential diagnosis of benign and malignant testicular lesions.

Building a diagnosis and prediction model for prostate cancer based on multimodal data / 中国医师杂志

Objective:To explore the diagnostic value of clinical, multi-parameter magnetic resonance imaging (MP-MRI) combined with transrectal ultrasound elasticity data for prostate cancer.Methods:A retrospective analysis was conducted on patient data from November 2021 to March 2023 when transrectal prostate two-dimensional ultrasound, real-time strain elastography of the prostate, MP-MRI examination of the prostate, and prostate biopsy were performed simultaneously at the Meizhou People′s Hospital. We collected patient age, height, weight, free serum prostate specific antigen (fPSA), total prostate specific antigen (tPSA), fPSA/tPSA, MRI prostate imaging report and data system (PI-RADS) scores, and ultrasound elasticity values. Four predictive models for prostate cancer diagnosis were constructed using multivariate logistic regression for comparison, and the optimal model was selected to construct a column chart. The diagnostic performance of different models was evaluated using receiver operating characteristic (ROC) curves, and the diagnostic performance of column charts was evaluated using calibration curves.Results:This study included a total of 117 patients with 117 prostate lesions, 47 benign prostate lesions, and 70 prostate cancer lesions. There were statistically significant differences in age, fPSA, tPSA, fPSA/tPSA, PI-RADS scores, and ultrasound elasticity values between benign and malignant lesions patients (all P<0.01). The area under the curve (AUC) of the clinical model (age+ tPSA+ fPSA+ fPSA/tPSA), MRI model (PI-RADS score), ultrasound elastic model, and clinical+ MRI+ ultrasound elastic combined model for diagnosing prostate cancer were 0.86, 0.86, 0.92, and 0.98, respectively. Conclusions:Compared with a single diagnostic model, the combination of age, tPSA, fPSA/tPSA, PI-RADS scores, and ultrasound elasticity value model can improve the diagnostic rate of prostate cancer.

Transrectal ultrasound examination of prostate cancer guided by fusion imaging of multiparametric MRI and TRUS: avoiding unnecessary mpMRI-guided targeted biopsy / 亚洲男科学杂志(英文版)

The purpose of this study was to explore transrectal ultrasound (TRUS) findings of prostate cancer (PCa) guided by multiparametric magnetic resonance imaging (mpMRI) and to improve the Prostate Imaging Reporting and Data System (PI-RADS) system for avoiding unnecessary mpMRI-guided targeted biopsy (TB). From January 2018 to October 2019, fusion mpMRI and TRUS-guided biopsies were performed in 162 consecutive patients. The study included 188 suspicious lesions on mpMRI in 156 patients, all of whom underwent mpMRI-TRUS fusion imaging-guided TB and 12-core transperineal systematic biopsy (SB). Univariate analyses were performed to investigate the relationship between TRUS features and PCa. Then, logistic regression analysis with generalized estimating equations was performed to determine the independent predictors of PCa and obtain the fitted probability of PCa. The detection rates of PCa based on TB alone, SB alone, and combined SB and TB were 55.9% (105 of 188), 52.6% (82 of 156), and 62.8% (98 of 156), respectively. The significant predictors of PCa on TRUS were hypoechogenicity (odds ratio [OR]: 9.595, P = 0.002), taller-than-wide shape (OR: 3.539, P = 0.022), asymmetric vascular structures (OR: 3.728, P = 0.031), close proximity to capsule (OR: 3.473, P = 0.040), and irregular margins (OR: 3.843, P = 0.041). We propose subgrouping PI-RADS score 3 into categories 3a, 3b, 3c, and 3d based on different numbers of TRUS predictors, as the creation of PI-RADS 3a (no suspicious ultrasound features) could avoid 16.7% of mpMRI-guided TBs. Risk stratification of PCa with mpMRI-TRUS fusion imaging-directed ultrasound features could avoid unnecessary mpMRI-TBs.

Preoperative evaluation of prostate cancer by 68Ga-PMSA positron emission tomography/computed tomography: comparison with magnetic resonance imaging and with histopathological findings / Avaliação pré-operatória do câncer de próstata pela tomografia por emissão de pósitrons/tomografia computadorizada com PSMA-68Ga: comparação com ressonância magnética e com achados histopatológicos

Abstract Objective: To evaluate the accuracy of preoperative positron emission tomography/computed tomography with 68Ga-labeled prostate-specific membrane antigen (68Ga-PSMA PET/CT) for staging prostate cancer and compare it with magnetic resonance imaging (MRI) using histopathology of surgical specimens as the gold standard. Materials and Methods: In this retrospective study, 65 patients with prostate cancer were analyzed. Results: The accuracy of 68Ga-PSMA PET/CT for tumor detection was 95%, and that of MRI was 91%. There was no difference between 68Ga-PSMA PET/CT and MRI regarding localization of the lesion. The sensitivity of 68Ga-PSMA PET/CT for detecting extraprostatic extension was quite low (14%). For detection of seminal vesicle invasion, 68Ga-PSMA PET/CT showed a sensitivity of 57% and accuracy of 91%. There was a moderate correlation between the maximum standardized uptake value (SUVmax) and the serum level of prostate-specific antigen (p < 0.01; ρ = 0.368) and between the SUVmax and the International Society of Urological Pathology (ISUP) grade (p < 0.01; ρ = 0.513). Conclusion: 68Ga-PSMA PET/CT is a promising tool for detecting and evaluating the primary tumor, which can alter the staging and management of the disease.

Resumo Objetivo: Avaliar a acurácia da tomografia por emissão de pósitrons/tomografia computadorizada com PSMA (PET-PMSA) pré-operatória para estadiamento do câncer de próstata e compará-la com a ressonância magnética (RM) utilizando o histopatológico cirúrgico como padrão ouro. Materiais e Métodos: Neste estudo retrospectivo foram analisados 65 pacientes com câncer de próstata. Resultados: A acurácia da PET-PSMA para a detecção tumoral foi de 95% e a da RM foi de 91%. Não houve diferença entre a PET-PSMA e a RM quanto à localização da lesão. A PET-PSMA apresentou baixa sensibilidade (14%) para detecção de extensão extraprostática em comparação ao histopatológico. Para detecção de invasão de vesícula seminal, a PET-PSMA apresentou sensibilidade de 57% e acurácia de 91% em comparação ao histopatológico. Houve correlação moderada entre o SUVmax e o PSA (p < 0,01; ρ = 0,368) e entre o SUVmax e o ISUP (p < 0,01; ρ = 0,513). Conclusão: A PET-PSMA é uma ferramenta promissora para detecção e avaliação do tumor primário, alterando o estadiamento e a conduta do paciente.

Magnetic resonance imaging at 3.0-T in postmenopausal osteoporosis: a prospective study and review of the literature / Ressonância magnética de 3.0-T na osteoporose pós-menopausa: estudo prospectivo e revisão da literatura

Abstract Objective: To promote advanced research using magnetic resonance imaging (MRI) in the diagnosis of and screening for osteoporosis by looking for correlations among the T-scores measured by dual-energy X-ray absorptiometry (DEXA), the apparent diffusion coefficient (ADC) values on diffusion-weighted imaging (DWI), and the T1-weighted signal intensity values. Materials and Methods: This was a prospective study of postmenopausal women with no contraindications to MRI and no history of cancer who underwent DEXA within 30 days before or after the MRI examination. A 3.0-T scanner was used in order to acquire sagittal sequences targeting the lumbar spine. Results: Thirteen women underwent DEXA and MRI. In two cases, the MRI was discontinued early. Therefore, the final sample comprised 11 patients. The ADC values and T1-weighted signal intensity were found to be higher in patients with osteoporosis. However, among the patients > 60 years of age with osteoporosis, ADC values were lower and T1-weighted signal intensity was even higher. Conclusion: It is unlikely that MRI will soon replace DEXA for the diagnostic workup of osteoporosis. Although DWI and ADC mapping are useful for understanding the pathophysiology of osteoporosis, we believe that T1-weighted sequences are more sensitive than is DWI as a means of performing a qualitative analysis of vertebral alterations.

Resumo Objetivo: Promover pesquisas avançadas usando ressonância magnética (RM) no diagnóstico e rastreamento de osteoporose, procurando correlações entre os escores T medidos por absorciometria de raios-X de dupla energia (DEXA), valores de coeficiente de difusão aparente (ADC) na difusão e valores de intensidade de sinal ponderado em T1. Materiais e Métodos: Estudo prospectivo de mulheres na pós-menopausa sem contraindicações para RM e sem histórico de câncer que foram submetidas a DEXA 30 dias antes ou após o exame de RM. Um scanner 3.0-T foi utilizado para adquirir sequências sagitais direcionadas à coluna lombar. Resultados: Treze mulheres foram submetidas a DEXA e RM. Em dois casos, a RM foi interrompida precocemente. Portanto, a amostra final foi composta por 11 pacientes. Os valores de ADC e intensidade de sinal ponderado em T1 foram mais elevados nas pacientes com osteoporose. No entanto, no subgrupo de pacientes > 60 anos de idade com osteoporose, os valores de ADC foram menores e a intensidade do sinal ponderado em T1 foi ainda maior. Conclusão: É improvável que a RM substitua DEXA para a investigação diagnóstica da osteoporose no futuro próximo. Embora a difusão e o mapeamento ADC sejam úteis para a compreensão da fisiopatologia da osteoporose, acreditamos que as sequências ponderadas em T1 são mais sensíveis do que a difusão como meio de realizar uma análise qualitativa das alterações vertebrais.

Risk factors and stratification of clinical significant prostate cancer in biopsy-naive patients with nonsuspicious multiparametric MRI / 中华泌尿外科杂志

Objective:To explore independent risk factors and risk stratification for diagnosis of clinically significant prostate cancer (CsPCa) in biopsy-naive patients with nonsuspicious multiparametric magnetic resonance imaging (mpMRI).Methods:The data of 549 patients who underwent initial systematic biopsy (SB) in the First Affiliated Hospital of Soochow University, the Second Affiliated Hospital of Soochow University and Traditional Chinese Medicine Hospital of Kunshan between October 2015 and January 2021 were retrospectively reviewed. Nonsuspicious mpMRI was defined as Prostate Imaging-Reporting and Data System (PI-RADS)≤2. All patients received systematic 12 core prostate biopsy, 278 of them by transperineal and 271 by transrectal biopsies. The median age of the patients was 67 (62, 73) years, the median prostate specific antigen (PSA) was 9.01 (6.15, 13.64) ng/ml, the median prostate volume was 48.41 (35.85, 64.28) ml, and 54 patients were positive in digital rectal examination (DRE). Taking CsPCa as the outcome index, receiver operating characteristic (ROC) analysis was performed on age, tPSA, f/tPSA and PSA density (PSAD) to obtain the optimal cut-off value, and logistics regression was used to explore the independent risk factor of CsPCa in mpMRI negative patients. The optimal cut-off value when the negative predictive value (NPV) of mpMRI diagnosis of CsPCa was 100%, was taken as the protective factor, and the risk stratification model was finally proposed.Results:Of all 549 cases, 44 were CsPCa, 35 were clinically insignificant prostate cancer and 470 were non-prostate cancer. There were significant differences in age (71 vs. 67 years old), tPSA (11.95 vs. 8.75 ng/ml), PSAD [0.31 vs. 0.18 ng/(ml·cm 3)], f/tPSA (0.12 vs. 0.16) and DRE positive rate (38.6% vs. 7.3%) between CsPCa group and non-CsPCa group ( P<0.01). Cut-off values were taken in ROC analysis when the Youden index was at its maximum. The optimal cut-off values of each continuous variable were: age=65 years, tPSA=10ng/ml, f/tPSA=0.2 and PSAD=0.15 ng/(ml·cm 3). Multivariate analysis showed that ages over 65 years ( OR=3.43, 95% CI 1.55-7.58, P=0.002), f/t PSA ratio<0.2 ( OR=3.84, 95% CI 1.28-11.56, P=0.016), PSAD>0.15 ng/(ml·cm 3) ( OR=3.60, 95% CI 1.13-11.51, P=0.03) and positive DRE ( OR=5.20, 95% CI 2.39-11.32, P<0.001) were independent risk factors of CsPCa. When NPV was 100%, the cut-off values were taken as the protective factors: age≤55 years, f/tPSA≥0.3, PSAD≤0.1 ng/(ml·cm 3). Combined with independent risk factors, preliminary risk stratification was conducted: those with ≥2 high risk factors were considered as high risk group, those with ≥2 protective factors were considered as low risk group, and the middle region was considered as medium risk group. Conclusions:Patients with age>65 years, f/tPSA<0.2, PSAD > 0.15 ng/(ml·cm 3) and DRE positive are independent risk factors of CsPCa in mpMRI negative patients. Patients in the high-risk group were recommended to undergo prostate biopsy, while patients in the low-risk group could be considered to avoid biopsy.

Diagnostic value of 18F-prostate specific membrane antigen PET/CT combined with multiparametric-MRI in identifying the grade group of prostate cancer / 中华泌尿外科杂志

Objective:To investigate the diagnostic value of the combination of 18F-prostate specific membrane antigen (PSMA) PET/CT and multiparametric magnetic resonance imaging (mpMRI) in identifying the grade group of prostate cancer, using parameters derived from the two imaging modalities. Method:Prostate cancer patients diagnosed by histopathology and received 18F-PSMA PET/CT and mpMRI during September 2018 to May 2021 in our hospital were retrospectively studied. The median age was 68(64-75), with the median PSA level of 14.74(7.75-24.19)ng/mL. All patients received mpMRI before biopsy. On biopsy, 6(12.2%) patients had International Society of Urological Pathology grade group(ISUP GG) 1 diseases, 16(32.7%) had ISUP GG 2 diseases, 12(24.5%) had ISUP GG 3 diseases, and 15(10.9%) had ISUP GG 4 or 5 diseases. Patients were then divided into high-grade group (ISUP 4-5) and low-grade group(ISUP 1-3). The median age of patients in high-grade group and low-grade group were 65(62-76) and 71(65-74), respectively. The PSA level in high-grade group and low-grade group were 15.11(6.63-42.86) ng/ml and 12.31(7.94-18.25) ng/ml, respectively. No significant differences were found in age and PSA level between the two groups ( P=0.334, P=0.448). All patients underwent 18F-PSMA PET/CT within 4 weeks after biopsy. The maximum standardized uptake value(SUV max) and the minimum apparent diffusion coefficient(ADC min)were recorded, and the ratio of SUV max/ ADC minwere calculated. The correlation between the above parameters and ISUP grade group were analyzed.The diagnostic value of the parameters was evaluated by the receiver operating characteristic (ROC) curve. Results:The data of 49 patients were analyzed. The average ADC minwas (0.57±0.16)×10 -3 mm 2/s, with the average SUV max and SUV max/ADC min of 15.30±12.54 and (29.69±23.72)×10 3, respectively. Statistical differences were found in SUV max ( P=0.012) and SUV max/ADC min ( P=0.002) between the high- and low-grade groups, while ADC min ( P=0.411) showed no statistical differences between the two groups. Significant positive correlations were found between SUV max(r=0.501, P<0.001), SUV max/ADC min (r=0.527, P<0.001) and ISUP grade group, respectively. There was a negative correlation between ADC min and ISUP grade group (r=-0.296, P=0.039). SUV max/ADC min was the best index to distinguish high-grade group from low-grade group prostate cancer with the area under the curve(AUC) of 0.749. In contrast, the AUC of SUV maxand ADC min were 0.731 and 0.615, respectively. The diagnostic sensitivity and specificity of SUV max/ADC min were 73.3% and 85.3%, respectively, with a critical value of 37.23×10 3. Conclusion:The combination use of 18F-PSMA PET/CT and mpMRI could improve the diagnostic efficiency for prostate cancer, compared to either modality alone. The ratio of SUV max/ADC min has a positive correlation with ISUP grade group, and is a promising index for distinguishing the high-grade prostate cancer from low-grade cancer.

Feasibility of radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by mpMRI and 68Ga-PSMA PET/CT / 中华泌尿外科杂志

Objective:To explore the feasibility of radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by multiparametric magnetic resonance imaging (mpMRI) and 68Ga-PSMA PET/CT. Methods:Patients were enrolled in this single-arm prospective study from March 2019 to January 2022 in the Second Hospital of Tianjin Medical University. Eligible patients were aged ≤80 years with an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. Based on mpMRI and 68Ga-PSMA PET/CT, patients were diagnosed with highly suspected localized prostate cancer with no evidence of distant lymphatic, bone or visceral metastases. Patients were excluded if they had obvious important organs dysfunction, suspected metastatic lesions or history of other malignant tumor. After fully informed of the surgical risks and possibilities of final pathology, patients received laparoscopic or robot-assisted laparoscopic radical prostatectomy. According to final pathological results, the diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT was evaluated. Pathological features were compared between low 68Ga-PSMA PET/CT maximum standardized uptake value (SUV max) group (SUV max<10) and high SUV max group (SUV max≥10). Baseline characteristics were compared between clinically significant prostate cancer (CsPCa) and clinically insignificant prostate cancer (cisPCa) + high grade prostatic intraepithelial neoplasia (HGPIN) patients. Additional analysis of the correlation between baseline parameters and different subgroups including pathological stage, ISUP grades and risk groups were performed in CsPCa patients. Results:31 patients were enrolled. Median age was 68 (ranging 48-79)years old. Median BMI was 25.6(ranging 21.9-31.4)kg/m 2. Median prostate specific antigen (PSA) was 23.5 (ranging 5.6-94.7)ng/ml. Median prostate volume was 37.6(ranging 16.2-127.9)ml. Median PSA density (PSAD) was 0.56(ranging 0.11-2.86)ng/ml 2. Fifteen cases were scored prostate imaging reporting and data system (PI-RADS) 4 and 16 cases were scored PI-RADS 5. Median 68Ga-PSMA PET/CT SUV max was 13.3 (ranging 4.6-36.7). All surgeries were successfully accomplished without open conversion. Median postoperative hospitalization time was 5 (ranging 4-7)d. No major complication occurred perioperatively. Recovery of urinary continence was within 6 months in all patients. According to the final pathological results, 1(3.2%) patient was confirmed with HGPIN. 30 (96.8%) patients were confirmed with adenocarcinoma, including 26 (86.7%) patients with CsPCa and 4(13.3%) patients with cisPCa. Among prostate cancer cases, the pathological stage of 11(36.7%) was T 2 and 19(63.3%) was T 3. Four(13.3%) cases were with ISUP grade 1, 7(23.3%) cases were with ISUP grade 2, 7(23.3%) cases were with ISUP grade 3 and 12 (40.0%) cases were with ISUP grade≥4.Two(6.7%) cases were in low risk group, 3(10.0%) cases were in intermediate risk group and 25 (83.3%) cases were in high risk group. Twelve(40.0%) patients had positive surgical margins. Standard pelvic lymph node dissection was carried out in 18 (17 prostate cancer and 1 HGPIN) cases. Sixty-two lymph nodes were dissected and none of them was positive. The diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT was 96.8%(30/31) in prostate cancer. Compared to low SUV max group, patients in high SUV max group had higher ISUP grade ( P=0.003) but there was no significant difference in positive surgical margin, seminal vesical invasion or pathological stage ( P>0.05). Among CsPCa patients, 10 (38.5%) cases were scored PI-RADS 4 and 16(61.5%) cases were scored PI-RADS 5. Median 68Ga-PSMA PET/CT SUV max was 14.3 (range 6.1-36.7). Compared to cisPCa and HGPIN patients, a smaller median prostate volume (34.3 vs. 73.0 ml, P=0.006), higher median PSAD (0.70 vs. 0.13 ng/ml 2, P=0.001), higher rates of PI-RADS 5 patients (61.5% vs. 0, P=0.018) and higher 68Ga-PSMA PET/CT SUV max (14.3 vs. 6.1, P=0.001) were found in CsPCa patients. Subgroup analysis showed no significant difference between SUV max and pathological stage (25.5 vs. 13.9), ISUP grades (15.4 vs. 14.4 vs. 14.0) and risk groups (9.7 vs. 14.9) in CsPCa patients ( P>0.05). Conclusions:The diagnostic accuracy of mpMRI and 68Ga-PSMA PET/CT is high in prostate cancer. With efficient communication, radical prostatectomy without biopsy for patients with highly suspected localized prostate cancer diagnosed by mpMRI and 68Ga-PSMA PET/CT is safe.

Clinical analysis of prostate targeted biopsy guided by multiparametric magnetic resonance imaging and 68Ga-PSMA PET/CT image fusion / 中华泌尿外科杂志

Objective:To explore clinical value of prostate target biopsy guided by multiparametric magnetic resonance imaging (mpMRI) and 68Ga-labeled prostate specific membrane antigen ligand imaging positron emission tomography/X-ray computed tomography ( 68Ga-PSMA PET/CT) image fusion. Methods:The data of 50 patients admitted to Fudan University Shanghai Cancer Center from January 2021 to February 2022 who underwent mpMRI and 68Ga-PSMA PET/CT to guide prostate biopsy were retrospectively analyzed. The median age was 70 (63-79) years, the median serum tPSA value was 8.1 (6.8-83.0) ng/ml, and the prostate volume was 45.5 (30-80) ml. 36 cases were positive by mpMRI, including PI-RADS score 3 in 5 cases, 4 score in 19 cases, 5 score in 12 cases. 32 cases were positive by 68Ga-PSMA PET/CT examination, of which 30 cases were double positive and the fusion of both imaging techniques was positive, referred to as PET/CT-MRI. The patient's mpMRI and 68Ga-PSMA PET/CT images were imported into the MIM fusion software, and the outline of the prostate and the target area were outlined respectively. When PET/CT and MRI double positive cases were biopsied, the two images were alternately fused, calibrated and locked with the real-time prostate ultrasound interface(PET/CT-MRI). Single-positive cases were guided by positive images to complete targeted biopsy, and 12-needle systematic biopsies were completed after targeted biopsy and double-negative cases. The advantages of targeted biopsy and systematic biopsy was evaluated, and the diagnostic performance (sensitivity, specificity, positive predictive value, and negative predictive value) was analyzed. Results:Among the 50 biopsy patients in this group, 31 (62%) had prostate cancer, of which 22 (44%) were CsPCa. There was no significant difference in the detection rate of prostate cancer between targeted biopsy and systematic biopsy [78.9% (30/38) and 62.0% (31/50), P=0.088], and there was no significant difference in the detection rate of CsPCa [57.9% (22/38) and 40.0% (20/50), P=0.096]. The positive rate of the biopsy needles number was significantly different [86.3% (69/80) and 19.0% (114/ 600), P<0.001]. The detection rates of prostate cancer in mpMRI positive, PET/CT positive and PET/CT-MRI positive cases were 83.3% (30/36), 90.6% (29/32) and 96.6% (29/30) respectively, the detection rates of CsPCa were 61.1% (22/36), 68.8% (22/32) and 73.3% (22/30) respectively.The sensitivity, specificity, positive predictive value and negative predictive value of mpMRI in the diagnosis of prostate cancer were 96.8%(30/31), 68.4%(13/19), 83.3%(30/36)and 92.9%(13/14), respectively.Those values in 68Ga-PSMA PET/CT were 93.5%(29/31), 84.2%(16/19), 90.6%(29/32)and 88.9%(16/18), respectively.Those values in PET/CT-MRI were 93.8%(29/31), 94.7%(18/19), 96.7%(29/30)and 90.0%(18/20), respectively. The above four indicators of mpMRI diagnosis of CsPCa were 100.0%(22/22), 50.0%(14/28), 61.1%(22/36)and 100.0%(14/14), respectively.Those indicators in 68Ga-PSMA PET/CT were 100.0%(22/22), 64.3%(18/28), 68.8%(22/32)and 100.0%(18/18), respectively.Those indicators in PET/CT-MRI was 100.0%(22/22), 71.4%(20/28), 73.2%(22/30)and 100.0%(20/20), respectively. The detection efficiency of PET/CT-MRI was better than that of mpMRI (Kappa value was 0.737, P=0.031). Conclusions:PET/CT-MRI image fusion-guided targeted prostate biopsy can effectively improve the detection efficiency of prostate cancer and clinically significant prostate cancer, and increase the positive rate.

Safety and efficacy of individualized transperineal prostate biopsy based on the segmentation of PI-RADS version 2 for mpMRI / 中华泌尿外科杂志

Objective:To investigate the safety and efficacy of individualized transperineal prostate biopsy based on the segmentation of PI-RADS v2 for mpMRI.Method:The clinical data of patients undergoing prostate biopsy in Beijing Friendship Hospital from December 2018 to November 2021 were analyzed retrospectively . A total of 228 patients with a median age of 65(49-83)years underwent biopsy. There were 102(44.7%) with tPSA <10 ng / ml, 108(47.4%) with tPSA 10-20 ng /ml, and 18(7.9%) with tPSA >20 ng /ml, with the median tPSA of 9.87(4.1-89.0)ng /ml. There were 42(18.4%) cases without MRI results, and 32(14.0%)cases with PI-RADS score of 1-2, 47(20.6%)cases of PI-RADS 3, 66(28.9%)cases of PI-RADS 4 and 41(18.1%)cases of PI-RADS 5, respectively.Transrectal ultrasound-guided transperineal prostate targeted biopsy (TB) and systematic biopsy (SB) were performed under local anesthesia or intravenous anesthesia. SB was performed for those without MRI and PI-RADS score of 1-2 (SB group), and TB and SB were performed for those with PI-RADS score of 3-5 (TB+ SB group). Prostate image under ultrasound was cognitively fused according to PI-RADS v2. One needle per area was distributed in 10 areas of each layer(the transition zone anterior and posterior sectors, the peripheral zone anterior, lateral, and medial sectors or central zone in left and right lobe). For those whose prostate length was less than 3cm, 10 needles were punctured, and two needles were added to each lateral lobe of the apex with a total of 14 needles. For those whose prostate length was from 3 to 6 cm, selected two layers with a total of 20 needles. For those with a length greater than 6cm, selected three layers with a total of 30 needles. If there was a suspicious lesion with PI-RADS score of 3-5, two needles were targeted for each lesion.The detection rate and complication rate of prostate cancer and clinically significant prostate cancer (csPCa) in the overall samples were observed, and the difference of the detection rate of prostate cancer and csPCa between the two groups was compared.Results:Of the 228 cases, there were 46 cases undergoing biopsy of one layer, 148 cases of two layers, and 34 cases of three layers, detecting 131 prostate cancer (PCa) diagnosed by pathology, with a detection rate of 57.5%, including 40 cases (17.5%)of clinically insignificant PCa and 91 cases(39.9%)of csPCa. The detection rate of PCa in TB+ SB group was 61.0%(94/154), which was higher than that in SB group, but there was no significant difference ( P=0.114). However, the detection rate of csPCa in TB + SB group was higher than that in SB group, which was 46.8%(72/154)vs. 25.6%(19/74), respectively ( P=0.002). In the combined TB and SB group (TB + SB group), the detection rate of csPCa by TB was 44.8% (69/154), which was higher than that of 33.8%(52/154)by SB( P=0.047). In the TB+ SB group, 7(4.5%) PCa were missed by SB, which was less than 18 cases (11.7%) missed by TB( P=0.022), but csPCa were missed by SB more than that missed by TB( P<0.001). There were 37 cases suffered from complications, with Clavien Dindo classification grade 1 of 29 cases (12.7%), grade 2 of 7 cases (3.1%), and grade 3 of 1 case(0.4%). Conclusions:Individualized transperineal prostate biopsy based on the segmentation of PI-RADS v2 for mpMRI is safe and reliable. Target biopsy by cognitive fusion can improve the detection rate of significant PCa. Systematic biopsy is also an important and essential supplement, which can detect prostate cancer missed by TB. Combined TB and SB are the best choice.

Efficacy of the biopsy strategy combining 6-core systematic and 3-core MRI-targeted biopsy in the detection of prostate cancer / 中华泌尿外科杂志

Objective:To investigate the efficacy of the biopsy strategy combining 6-core systematic and 3-core MRI-targeted biopsy on prostate cancer (PCa) detection in biopsy-na?ve patients.Methods:The clinical data of 121 biopsy-na?ve patients who underwent transperineal prostate biopsy in West China Hospital of Sichuan University from July 2018 to January 2020 were retrospectively analyzed. The average age was (64.7±9.1) years old. Pre-biopsy prostate-specific antigen (PSA) was (12.4±7.5)ng/ml, f/t PSA was 0.13±0.05. Prostate volume was (43.1±26.1) ml and PASD was (0.35±0.27) ng/ml 2. The prostate-imaging and data system (PI-RADS) score of MRI before biopsy was reported to be 3 for 29 patients (24.0%), 4 for 54 patients (44.6%) and 5 for 38 patients (31.8%). All 121 patients underwent 12-core systematic biopsy combined with a 3-core or 5-core MRI-targeted biopsy, of which 61 patients underwent 3-core targeted biopsy and 60 underwent 5-core targeted biopsy. There was no significant difference in the pre-biopsy clinical data between the two groups ( P>0.05). A 6-core systematic biopsy was redefined as the results of 6 cores among the 12-core systematic biopsy. We compared the detection rates among the single 12-core systematic biopsy, 6-core systematic biopsy, MRI-targeted biopsy (3-core or 5-core), and different systematic biopsy combing with targeted biopsy for any PCa and clinically significant PCa, and we also analyzed the cumulative cancer detection rates for MRI-targeted biopsy of different cores. Results:Of the 121 patients in this study, the biopsy results were negative for 43 patients (35.5%) and positive for 78 (64.5%). The detection rate of clinically significant PCa was 55.4% (67/121). The detection rate of the 6-core systematic biopsy combined with MRI-targeted biopsy was 62.0% (75/121) for PCa and 55.4% (67/121) for clinically significant PCa, which was of no difference compared with that for the 12-core systematic biopsy combined with MRI-targeted biopsy ( P>0.05), but the 6-core systematic biopsy combined with MRI-targeted biopsy avoided the overdiagnosis of 3 patients with Gleason score 3+ 3. The detection rate of PCa for MRI-targeted biopsy was 57.9% (70/121), including 42.1% (51/121) for the first core, 55.4% (67/121) for the first two cores, and 57.9% (70/121) for the first three cores. Compared with the single-core targeted biopsy for suspicious lesions, the first 2-core targeted biopsy ( OR=1.7, 95% CI 1.0-2.8) and 3-core targeted biopsy ( OR=1.9, 95% CI 1.1-3.1) can significantly increase the detection rate of PCa, while the fourth or fifth core of targeted biopsy can not increase the detection rate additionally (60%, 36/60). Conclusion:For patients with suspected PCa, the prostate biopsy strategy combing 6-core systematic and 3-core MRI-targeted biopsy performs no inferior than the current 12-core systematic biopsy combined with MRI-targeted biopsy.

Predictive value of multiparametric MRI for prostate cancer pathology and tumor staging / 中国辐射卫生

Objective To evaluate the value of multiparametric MRI for prediction of prostate cancer pathology and tumor staging. Methods A total of 80 patients with prostate cancer admitted during the period from 2016 to 2021 were enrolled as the study subjects, and all patients underwent multiparametric MRI. The pathological examination of radical prostatectomy specimens was used as a gold standard to evaluate the predictive value of multiparametric MRI for significant prostate cancaer, extracapsular extension, index lesion location and lymph node metastasis. Results Multiparametric MRI showed a sensitive of 96%, specificity of 60%, positive predictive value of 97.3% and negative predictive value of 50% for prediction of significant prostate cancer, and the concordance between multiparametric MRI and pathology of radical prostatectomy specimens was 75% for prediction of index lesions. In addition, multiparametric MRI showed a 40% sensitivity, 91.4% specificity, 85.7% positive predictive value and 54.2% negative predictive value for identification of extracapsular extension and a 16.7% accuracy for detection of lymph node metastasis. Conclusion Multiparametric MRI is highly sensitive for predicting significant prostate cancer with a high positive predictive value and is highly accurate for identification of index lesions of prostate cancer, which is of great value to propose prostate cancer treatment schemes and evaluate the clinical prognosis among prostate cancer patients.

Prostatitis crónica: Aporte del contraste endovenoso en fase tardía para su caracterización en resonancia magnética multiparamétrica de próstata / Chronic Prostatitis: Contrast Contribution in Late Phase for its Characterization in Multiparametric-Magnetic Resonance Imaging of the Prostate

Resumen Objetivo: El objetivo de este estudio es demostrar la utilidad de una secuencia tardía post-contraste en la resonancia magnética multiparamétrica de próstata (RMMP) para caracterizar lesiones PI-RADS II. Materiales y métodos: Se analizaron en forma retrospectiva las RMMP realizadas entre enero de 2015 y diciembre de 2016. El protocolo de la RMMP fue basado en las recomendaciones del PI-RADS versión 2, y se agregó una adquisición tardía luego del dinámico post-contraste. Los reportes fueron revisados bajo la versión 2.1. Resultados: Se seleccionaron 31 pacientes que presentaron lesiones categorizadas como PI-RADS II en la zona periférica, los cuales se encontraban en seguimiento del antígeno prostático específico y presentaron confirmación histológica de prostatitis crónica. Se evidenció un realce tardío de la lesión en todos los pacientes. Según los resultados histopatológicos, 30 presentaban prostatitis crónica y el restante tejido benigno (tejido fibromuscular). Discusión: La prostatitis crónica no muestra realce temprano, y presenta realce tardío debido al tejido conectivo fibroso que la compone. En la RMMP, la prostatitis puede imitar el cáncer de próstata. Agregar una adquisición tardía solo adiciona 150 segundos al estudio y podría ayudar a resolver aquellos casos inciertos categorizados como PI-RADS III empleando las secuencias convencionales, debido a que el realce tardío de la lesión es altamente sugestivo de un proceso inflamatorio (PI-RADS II). Conclusión: La presencia de realce tardío es una herramienta útil para realizar un adecuado diagnóstico de una lesión PI-RADS II en la zona periférica, pudiendo evitar una biopsia innecesaria.

Abstract Objective: The aim of this study is to demonstrate the utility of a post-contrast late sequence in multiparametric magnetic resonance imaging (RMMP) to characterize PI-RADS II lesions. Materials and methods: The RMMPs performed between January 2015 and December 2016 were retrospectively analyzed. The RMMP protocol was based on the recommendations of the PI-RADS version 2, and a late acquisition was added, after the dynamic post-contrast. The reports were reviewed under the version 2.1. Results: 31 patients with PI-RADS II lesions in the peripheral zone were selected, who were in prostate specific antigen follow-up and had histological confirmation of chronic prostatitis. A late enhancement of the lesion was evidenced in all patients. According to the histopathological results, 30 had chronic prostatitis and the remaining benign tissue (fibromuscular tissue). Discussion: Chronic prostatitis does not show early enhancement, and presents late enhancement due to its fibrous connective tissue. In RMMP, prostatitis may mimic prostate cancer. Adding a late sequence only adds 150 seconds to the study and could help to resolve those uncertain cases categorized as PI-RADS III using traditional sequences because the late enhancement of the lesion is highly suggestive of an inflammatory process (PI-RADS II). Conclusion: The presence of late enhancement is a useful tool to perform an adequate diagnosis of a PI-RADS II lesion in the peripheral zone, helping to avoid an unnecessary biopsy.

Comparative study on the diagnostic value of multiparametric transrectal ultrasound and multiparametric MRI in prostate cancer / 中华泌尿外科杂志

Objective@#The aim of the study is to compare the diagnostic value of multiparametric transrectal ultrasound(TRUS) and multiparametric magnetic resonance imaging (MRI) in prostate cancer.@*Methods@#The clinical data of 102 patients who received multiparametric TRUS (including conventional transrectal ultrasound, shear wave sonoelastography and contrast enhanced ultrasound), multiparametric MRI(including T2 weighted diffusion weighted, and dynamic contrast enhanced MRI) and laboratory tests from April 2016 to May 2018 were retrospectively analyzed. The average age was 66.1 years old, ranging 38.0-85.0 years old. The average PSA was 30.1 ng/ml, ranging 0.4-227.0 ng/ml. The average PSAD was 0.67 ng/ml2, ranging 0.02-4.27 ng/ml2. The pathology results from TRUS guided biopsy or surgical operation were chosen as gold standard. Diagnostic performance including sensitivity, specificity, positive predictive value(PPV), negative predictive value(NPV), accuracy and area under the receiver operating characteristic curve(AUROC)of multiparametric TRUS and multiparametric MRI in prostate cancer were analyzed.@*Results@#There were 62 prostate cancer and 40 BPH patients in our study. Parallel multiparametric TRUS diagnosed 63 prostate cancer and 39 BPH, and multiparametric MRI diagnosed 75 prostate cancer and 27 BPH. The sensitivity, specificity and accuracy of parallel multiparametric TRUS were 98.4%, 70.0% and 87.3%, respectively. And those of multiparametric MRI were 95.2%, 60.0% and 81.4%, respectively. The AUROC of parallel multiparametric TRUS and multiparametric MRI were 0.842 and 0.776, with no significant differences(P=0.208).@*Conclusion@#The diagnostic value of multiparametric TRUS was not inferior to multiparametric MRI in prostate cancer.

Comparative study on the diagnostic value of multiparametric transrectal ultrasound and multiparametric MRI in prostate cancer / 中华泌尿外科杂志

Objective The aim of the study is to compare the diagnostic value of multiparametric transrectal ultrasound(TRUS) and multiparametric magnetic resonance imaging (MRI) in prostate cancer.Methods The clinical data of 102 patients who received multiparametric TRUS (including conventional transrectal ultrasound,shear wave sonoelastography and contrast enhanced ultrasound),multiparametric MRI (including T2 weighted diffusion weighted,and dynamic contrast enhanced MRI) and laboratory tests from April 2016 to May 2018 were retrospectively analyzed.The average age was 66.1 years old,ranging 38.0-85.0 years old.The average PSA was 30.1 ng/ml,ranging 0.4-227.0 ng/ml.The average PSAD was 0.67 ng/ml2,ranging 0.02-4.27 ng/ml2.The pathology results from TRUS guided biopsy or surgical operation were chosen as gold standard.Diagnostic performance including sensitivity,specificity,positive predictive value (PPV),negative predictive value (NPV),accuracy and area under the receiver operating characteristic curve (AUROC) of multiparametric TRUS and multiparametric MRI in prostate cancer were analyzed.Results There were 62 prostate cancer and 40 BPH patients in our study.Parallel multiparametric TRUS diagnosed 63 prostate cancer and 39 BPH,and multiparametric MRI diagnosed 75 prostate cancer and 27 BPH.The sensitivity,specificity and accuracy of parallel multiparametric TRUS were 98.4％,70.0％ and 87.3％,respectively.And those of multiparametric MRI were 95.2％,60.0％ and 81.4％,respectively.The AUROC of parallel multiparametric TRUS and multiparametric MRI were 0.842 and 0.776,with no significant differences (P =0.208).Conclusion The diagnostic value of multiparametrie TRUS was not inferior to multiparametrie MRI in prostate cancer.

Concordance of multiparameteric MRI and MRI ultrasound fusion-guided prostate biopsy

@#Multiparametric MRI (mpMRI) of the prostate is recently becoming more and more utilized in the detection of prostate cancer. Studies have shown that a higher PIRADS score correlated to a higher chance of obtaining a clinically significant prostate cancer but few studies have correlated PIRADS score to a specific Gleason score.@*OBJECTIVE@#This study aimed to determine the concordance of PIRADS score to the Gleason score result of MRI ultrasound fusion-guided prostate biopsy.@*METHODS@#All patients who had at least a PIRADS 2 lesion on mpMRI and underwent MRI ultrasound fusion-guided biopsy of the prostate from August 2018 up to November 2019 at St. Luke’s Medical Center, Global City were included in the study. An ambispective collection of data was done until the ideal sample size of greater than 100 positive lesions was obtained, in order to derive concordance rate.@*RESULTS@#One hundred and sixty-two patients were included in the study with a total of 212 lesions analyzed. Forty three percent were benign while 57% were found to be malignant. PIRADS 2 lesions had zero high grade cancers, and the percentage steadily increased with 37.8% of PIRADS lesions considered high grade. Concordance was computed to be 0.38 showing a fair, direct concordance between PIRADS and Gleason score with significant result (p<0.05).@*CONCLUSION@#A result of PIRADS 4 or 5 lesion on mpMRI will have a higher urgency of doing a prostate biopsy and subsequent management to prevent unfavorable outcomes as opposed to PIRADS 3 lesions.

FLI1 and MIC2 expression in precursor B-lymphoblastic leukemia with Burkitt-like morphology and extensive extramedullary involvement: A diagnostic challenge in pediatric small round cell tumor

Pediatric small round cell tumors (PSRCTs) constitute a large proportion of childhood malignancies with overlapping diagnostic and clinical features but radically different therapies. Here, we report a case of 16-year-old male child presenting with diffuse abdominal and mediastinal mass, axillary lymphadenopathy, and pleural effusion. Bone marrow aspirate showed near total replacement by small round malignant cells. The bone marrow biopsy showed interstitial infiltration by malignant cells, which were CD45? CD3? CD20? MIC2+ FLI1+ and diagnosis of Ewing's sarcoma was established. In contrast, flowcytometric immunophenotyping of the bone marrow aspirate showed CD45? cells, which were CD19+ cytCD79a+ CD10+ CD81+ CD38+ HLA-DR+ CD22+ CD20? consistent with B-cell acute lymphoblastic leukemia (B-ALL). The extended immunostaining panel on bone marrow biopsy also showed positivity for cytCD79a, CD10, CD19, and BCL-2, whereas fluorescent in-situ hybridization for EWSR1 gene rearrangement was negative. Thus, a final diagnosis of CD45? FLI1+ MIC2+ B-ALL was established. Rare cases of CD45? B-ALL with immunoreactivity for MIC2 and Friend leukemia virus integration 1 (FLI1) have posed a diagnostic challenge for PSRCTs in the recent past. This case report highlights the role of multimodality approach in establishing a correct diagnosis in CD45? PSRCTs to ensure definitive therapy and better clinical outcome.

Densidad de APE en pacientes PI-RADS 3: un parámetro clínico útil para su manejo / PSA density as a new approach for PIRADS 3 patient's management

Resumen: Objetivo: Analizar las biopsias realizadas en paciente categorizados PIRADS 3 en nuestra institución desde el segundo semestre del año 2016 al primer semestre del año 2018 y describir la correlación de la densidad de PSA con la incidencia de cáncer de próstata. Evaluar el rol de la densidad de PSA en la indicación de estudio histológico en pacientes PIRADS 3. Método: Trabajo autorizado por el comité de ética de nuestra institución. Se realizó búsqueda en el PACs, de todos los informes de RM multiparamétricas de próstata que incluyeran la categoría ¨PIRADS 3¨ en el periodo señalado. De ellos se calculó la densidad de PSA, con el último valor de PSA registrado en la ficha clínica previo a RM y volumen prostático en RM. Se procedió a buscar los pacientes con estudio histológico. Se correlacionó los resultados de biopsias con el valor de densidad de PSA. Realizamos análisis uni y multivariados, análisis estadísticos con sensibilidad, especificidad y uso de curva ROC. Resultados: De las 2416 RMmp de próstata realizadas en nuestra institución en las fechas ya descritas, se encontraron 424 informes catalogados con score PIRADS 3, y 267 de esos pacientes tenían estudio y seguimiento institucional, de los cuales 134 contaban con biopsia. La muestra tenía un promedio de edad de 60 años, y una mediana de densidad de PSA de 0,10 (RIC 0,07-0,14). Se encontraron 36 biopsias con cáncer clínicamente significativo (Gleason > 6), lo que corresponde a 26,8% de la muestra, valor similar al encontrado en la literuatua. En estos pacientes se obtuvo un punto de corte óptimo de densidad de PSA de 0,11, con una sensibilidad y especificidad de 67% y un AUC de 0,68. Una densidad de PSA de 0,11 presenta un OR de 4,1, con una probabilidad de 4 veces más de encontrar un cáncer de próstata por sobre este valor (IC 95% 1,3-9,8), lo cuál es estadísticamente significativo con un p igual a 0,01. Conclusión: La DAPE sobre 0,11 ng/ml/cc puede considerarse como una herramienta adicional para indicar biopsia en pacientes con RMmp PI-RADS 3, aumentando la precisión para la detección de cáncer de próstata clínicamente significativos ayudando a disminuir estudios histológicos innecesarios.

Abstract: Objective: To analyze the biopsies performed in patients categorized PIRADS 3 in our institution from the second half of 2016 to the first half of 2018 and describe the correlation of PSA density with the incidence of prostate cancer. To evaluate the role of PSA density in the indication of histological study in PIRADS 3 patients. Method: Work authorized by the ethics committee of our institution. The PACs were searched for all multiparameter prostate MRI reports that included the category "PIRADS 3" in the period indicated. The PSA density was calculated, with the last PSA value recorded in the clinical record before MRI and prostate volume in MRI. We proceeded to look for patients with the histological study. The biopsy results were correlated with the PSA density value. We perform uni and multivariate analyzes, statistical analyzes with sensitivity, specificity and use of the ROC curve. Results: Of the 2416 RMmp of the prostate performed in our institution on the dates already described, 424 reports catalogued with PIRADS 3 score were found, and 267 of those patients had study and institutional follow-up, of which 134 had a biopsy. The sample had an average age of 60 years and a median PSA density of 0.10 (RIC 0.075-0.146). We found 36 biopsies with clinically significant cancer (Gleason> 6), which corresponds to 26.8% of the sample, a value similar to that found in the literature. In these patients, an optimal cut-off point of PSA density of 0.11 was obtained, with a sensitivity and specificity of 67% and an AUC of 0.68. A PSA density of 0.11 has an OR of 4.1, with a 4-fold probability of finding prostate cancer above this value (95% CI 1.3-9.8), which It is statistically significant with a p equal to 0.01. Conclusion: DAPE over 0.11 ng/ml/cc can be considered as an additional tool to indicate biopsy in patients with RMmp PI-RADS 3, increasing the accuracy for the detection of clinically significant prostate cancer helping to reduce unnecessary histological studies.