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OBJECTIVE: To evaluate the impact of applying the 2014 and 2019 International Society of Urological Pathology (ISUP) recommendations on grade group distribution and concordance with radical prostatectomy (RP). MATERIALS AND METHODS: Overall, 655 biopsy-naïve patients diagnosed by magnetic resonance imaging (MRI) targeted and systematic biopsies for Prostate Imaging Reporting and Data System score ≥3 lesions were identified from a prospectively maintained database from 2016 and 2022. Clinically significant prostate cancer was detected in 249 patients, of whom 69 underwent RP. Wilcoxon signed rank and McNemar's tests were used to compare the ISUP grade group distribution and concordance with RP after applying the 2014 (i.e., highest grade) and 2019 (i.e., global grade) ISUP recommendations, respectively. RESULTS: Compared to the 2014 ISUP recommendations, the 2019 ISUP recommendations were associated with a significant decrease in ISUP Grade Group 4 (range of difference from -13% to -5%) and an increase in ISUP Grade Group 2 (range of difference from +6% to +11%) in MRI targeted biopsy only, MRI targeted with perilesional biopsies, and MRI targeted with systematic biopsies (all P < 0.01). In patients who underwent RP, a significant decrease in downgrading was observed with all biopsy strategies (range of difference from -19% to -12%; P ≤ 0.008), along with an increase in concordance with RP specimen (range of difference from +12% to +13%; P ≤ 0.02). The use of the 2019 ISUP recommendation was associated with RP specimen a lower treatment burden. CONCLUSIONS: The use of the 2019 ISUP recommendations mitigates the grade migration induced by MRI targeted biopsy and improves the concordance with the final RP specimen.
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Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/patología , Biopsia , Próstata/diagnóstico por imagen , Próstata/patología , Clasificación del Tumor , Imagen por Resonancia Magnética/métodos , Prostatectomía/métodos , Sobretratamiento , Biopsia Guiada por Imagen , Estudios RetrospectivosRESUMEN
OBJECTIVE: To assess histopathological outcomes, as well as feasibility and safety of targeted microwave ablation (TMA) via the Trinity® system (KOELIS, La Tronche, France). PATIENTS AND METHODS: Prospective, single-institution, interventional Phase IIa study with an 'ablate-and-resect' design. In all, 11 patients diagnosed with localised prostate cancer (PCa) underwent TMA via the Trinity system under conscious sedation in an outpatient setting using a single transrectal TATO® 18-G antenna with different treatment regimens. Magnetic resonance imaging (MRI) and robot-assisted radical prostatectomy (RARP) were conducted at 7 days and 1 month after TMA, respectively. Nine patients received RARP, and two patients chose to withdraw their consent following TMA. These men chose an active surveillance protocol upon confirmation of a low-risk prostate cancer diagnosis. Functional outcomes and adverse events were evaluated at baseline and follow-up visits using validated questionnaires. Prostate volumetry and confirmation of necrosis were carried out through MRI and whole-mount histopathological examination. RESULTS: The TMA was successfully executed, and all patients were discharged on the same day. No severe adverse events (Common Terminology Criteria for Adverse Events Grade ≥3) were reported at the 7-day and 1-month follow-up visits. Additionally, no declines were observed in urinary, sexual and ejaculation functional outcomes. T1-weighted MRI revealed clear and well-defined ablation zones. The RARP was executed without difficulty, particularly during the dissection of the posterior plane. As a result, no intraoperative complications were encountered. Histopathological assessment on surgical specimens confirmed the absence of viable cells, indicating complete necrosis of the ablative zone if a power intensity >10 W was used during TMA. Ablation zone volumetry revealed no notable distinctions between the three-dimensional segmentation of the virtual ablation zone at TMA (median volume: 2 mL) and MRI (median volume: 1.923 mL). Conversely, a significant reduction was noted in the surgical specimen (median volume: 0.221 mL). CONCLUSIONS: Targeted microwave ablation via the Trinity system for localised PCa treatment proves to be a secure and feasible procedure, with complete necrosis evidence within the ablation zone on surgical specimens.
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Microondas , Prostatectomía , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Estudios Prospectivos , Anciano , Persona de Mediana Edad , Microondas/uso terapéutico , Prostatectomía/métodos , Estudios de Factibilidad , Resultado del Tratamiento , Técnicas de Ablación/métodos , Procedimientos Quirúrgicos Robotizados , Imagen por Resonancia MagnéticaRESUMEN
PURPOSE: Magnetic resonance imaging (MRI) is a promising tool for risk assessment, potentially reducing the burden of unnecessary prostate biopsies. Risk prediction models that incorporate MRI data have gained attention, but their external validation and comparison are essential for guiding clinical practice. The aim is to externally validate and compare risk prediction models for the diagnosis of clinically significant prostate cancer (csPCa). METHODS: A cohort of 4606 patients across fifteen European tertiary referral centers were identified from a prospective maintained database between January 2016 and April 2023. Transrectal or transperineal image-fusion MRI-targeted and systematic biopsies for PI-RADS score of ≥ 3 or ≥ 2 depending on patient characteristics and physician preferences. Probabilities for csPCa, defined as International Society of Urological Pathology (ISUP) grade ≥ 2, were calculated for each patients using eight models. Performance was characterized by area under the receiver operating characteristic curve (AUC), calibration, and net benefit. Subgroup analyses were performed across various clinically relevant subgroups. RESULTS: Overall, csPCa was detected in 2154 (47%) patients. The models exhibited satisfactory performance, demonstrating good discrimination (AUC ranging from 0.75 to 0.78, p < 0.001), adequate calibration, and high net benefit. The model described by Alberts showed the highest clinical utility for threshold probabilities between 10 and 20%. Subgroup analyses highlighted variations in models' performance, particularly when stratified according to PSA level, biopsy technique and PI-RADS version. CONCLUSIONS: We report a comprehensive external validation of risk prediction models for csPCa diagnosis in patients who underwent MRI-targeted and systematic biopsies. The model by Alberts demonstrated superior clinical utility and should be favored when determining the need for a prostate biopsy.
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Imagen por Resonancia Magnética , Próstata , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Medición de Riesgo/métodos , Anciano , Imagen por Resonancia Magnética/métodos , Persona de Mediana Edad , Próstata/patología , Próstata/diagnóstico por imagen , Biopsia Guiada por Imagen/métodos , Valor Predictivo de las PruebasRESUMEN
PURPOSE: Utility of prostate-specific antigen density (PSAd) for risk-stratification to avoid unnecessary biopsy remains unclear due to the lack of standardization of prostate volume estimation. We evaluated the impact of ellipsoidal formula using multiparametric magnetic resonance (MRI) and semi-automated segmentation using tridimensional ultrasound (3D-US) on prostate volume and PSAd estimations as well as the distribution of patients in a risk-adapted table of clinically significant prostate cancer (csPCa). METHODS: In a prospectively maintained database of 4841 patients who underwent MRI-targeted and systematic biopsies, 971 met inclusions criteria. Correlation of volume estimation was assessed by Kendall's correlation coefficient and graphically represented by scatter and Bland-Altman plots. Distribution of csPCa was presented using the Schoots risk-adapted table based on PSAd and PI-RADS score. The model was evaluated using discrimination, calibration plots and decision curve analysis (DCA). RESULTS: Median prostate volume estimation using 3D-US was higher compared to MRI (49cc[IQR 37-68] vs 47cc[IQR 35-66], p < 0.001). Significant correlation between imaging modalities was observed (τ = 0.73[CI 0.7-0.75], p < 0.001). Bland-Altman plot emphasizes the differences in prostate volume estimation. Using the Schoots risk-adapted table, a high risk of csPCa was observed in PI-RADS 2 combined with high PSAd, and in all PI-RADS 4-5. The risk of csPCa was proportional to the PSAd for PI-RADS 3 patients. Good accuracy (AUC of 0.69 and 0.68 using 3D-US and MRI, respectively), adequate calibration and a higher net benefit when using 3D-US for probability thresholds above 25% on DCA. CONCLUSIONS: Prostate volume estimation with semi-automated segmentation using 3D-US should be preferred to the ellipsoidal formula (MRI) when evaluating PSAd and the risk of csPCa.
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Antígeno Prostático Específico , Próstata , Neoplasias de la Próstata , Humanos , Masculino , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/diagnóstico por imagen , Antígeno Prostático Específico/sangre , Anciano , Persona de Mediana Edad , Tamaño de los Órganos , Próstata/patología , Próstata/diagnóstico por imagen , Medición de Riesgo , Biopsia Guiada por Imagen/métodos , Imagen por Resonancia Magnética/métodos , Toma de Decisiones Clínicas , Imágenes de Resonancia Magnética Multiparamétrica , Estudios ProspectivosRESUMEN
PURPOSE: There is currently no consensus regarding the optimal number of multiparametric magnetic resonance imaging (MRI)-targeted biopsy (TB) cores and their spatial distribution within the MRI lesion. We aim to determine the number of TB cores and location needed to adequately detect csPCa. METHODS: We conducted a retrospective cohort study of 505 consecutive patients undergoing TB for positive MRI lesions defined by a PI-RADS score ≥ 3 between June 2016 and January 2022. Cores chronology and locations were prospectively recorded. The co-primary outcomes were the first core to detect clinically significant prostate cancer (csPCa) and the first highest ISUP grade group. The incremental benefit of each additional core was evaluated. Analysis was then performed by distinguishing central (cTB) and peripheral (pTB) within the MRI lesion. RESULTS: Overall, csPCa was detected in 37% of patients. To reach a csPCa detection rate of 95%, a 3-core strategy was required, except for patients with PI-RADS 5 lesions and those with PSA density ≥ 0.2 ng/ml/cc who benefited from a fourth TB core. At multivariable analysis, only a PSA density ≥ 0.2 ng/ml/cc was an independent predictive factor of having the highest ISUP grade group on the fourth TB cores (p = 0.03). No significant difference in the cancer detection rate was found between cTB and pTB (p = 0.9). Omitting pTB would miss 18% of all csPCa. CONCLUSION: A 3-core strategy should be considered for TB to optimize csPCa detection with additional cores needed for PI-RADS 5 lesions and high PSA density. Biopsy cores from both central and peripheral zones are required.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Antígeno Prostático Específico , Imagen por Resonancia Magnética/métodos , Estudios Retrospectivos , Biopsia , Biopsia Guiada por Imagen/métodosRESUMEN
PURPOSE: Sampling perfection with application-optimized contrasts by using different flip angle evolutions (SPACE) is a black-blood 3D T1-weighted (T1w) magnetic resonance imaging (MRI) sequence that has shown robust performance for brain metastases detection. However, this could generate false positive results due to suboptimal blood signal suppression. For that reason, SPACE is used in our institution alongside a non-black-blood T1w sequence: volumetric interpolated breath-hold examination (VIBE). Our study aims to (i) evaluate the diagnostic accuracy of SPACE compared to its use in combination with VIBE, (ii) investigate the effect of radiologist's experience in the sequence's performance, and (iii) analyze causes of discordants results. METHODS: Four hundred seventy-three 3T MRI scans were retrospectively analyzed following a monocentric study design. Two studies were formed: one including SPACE alone and one combining both sequences (SPACE + VIBE, the reference). An experienced neuroradiologist and a radiology trainee independently reviewed the images of each study and reported the number of brain metastases. The sensitivity (Se) and specificity (Sp) of SPACE compared to SPACE + VIBE in metastases detection were reported. Diagnostic accuracy of SPACE compared to SPACE + VIBE was assessed by using McNemar's test. Significance was set at p < 0.05. Cohen's kappa was used for inter-method and inter-observer variability. RESULTS: No significant difference was found between the two methods, with SPACE having a Se > 93% and a Sp > 87%. No effect of readers' experience was disclosed. CONCLUSION: Independently of radiologist's experience, SPACE alone is robust enough to replace SPACE + VIBE for brain metastases detection.
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Neoplasias Encefálicas , Imagenología Tridimensional , Humanos , Estudios Retrospectivos , Flujo de Trabajo , Imagenología Tridimensional/métodos , Neoplasias Encefálicas/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Medios de ContrasteRESUMEN
This study evaluates the benefit of weekly delineation and peer review by a multidisciplinary team (MDT) of radiation oncologists (ROs), radiologists (RXs), and nuclear medicine (NM) physicians in defining primary and lymph node tumor volumes (GTVp and GTVn) for head and neck cancer (HNC) radiotherapy. This study includes 30 consecutive HNC patients referred for definitive curative (chemo)-radiotherapy. Imaging data including head and neck MRI, [18F]-FDG-PET and CT scan were evaluated by the MDT. The RO identified the 'undeniable' tumor as GTVp_core and determined GTVp_max, representing the maximum tumoral volume. The MDT delineation (MDT-D) by RX and NM physicians outlined their respective primary GTVs (GTVp_RX and GTVp_NM). During the MDT meeting (MDT-M), these contours were discussed to reach a consensus on the final primary GTV (GTVp_final). In the comparative analysis of various GTVp delineations, we performed descriptive statistics and assessed two MDT-M factors: 1) the added value of MDT-M, which includes the section of GTVp_final outside GTVp_core but within GTVp_RX or GTVp_NM, and 2) the part of GTVp_final that deviates from GTVp_max, representing the area missed by the RO. For GTVn, discussions evaluated lymph node extent and malignancy, documenting findings and the frequency of disagreements. The average GTVp core and max volumes were 19.5 cc (range: 0.4-90.1) and 22.1 cc (range: 0.8-106.2), respectively. Compared to GTVp_core, MDT-D to GTVp_final added an average of 3.3 cc (range: 0-25.6) and spared an average of 1.3 cc (0-15.6). Compared to GTVp_max, MDT-D and -M added an average of 2.7 cc (range: 0-20.3) and removed 2.3 cc (0-21.3). The most frequent GTVn discussions included morphologically suspicious nodes not fixing on [18F]-FDG-PET and small [18F]-FDG-PET negative retropharyngeal lymph nodes. Multidisciplinary review of target contours in HNC is essential for accurate treatment planning, ensuring precise tumor and lymph node delineation, potentially improving local control and reducing toxicity.
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Efficacy of the human epidermal growth factor receptor (HER)2-targeting trastuzumab emtansine (T-DM1) in breast cancer (BC) relies on HER2 status determined by immunohistochemistry or fluorescence in-situ hybridization. Heterogeneity in HER2 expression, however, generates interest in "whole-body" assessment of HER2 status using molecular imaging. We evaluated the role of HER2-targeted molecular imaging in detecting HER2-positive BC lesions and patients unlikely to respond to T-DM1. Patients underwent zirconium-89 (89Zr) trastuzumab (HER2) PET/CT and [18F]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT before T-DM1 initiation. Based on 89Zr-trastuzumab uptake, lesions were visually classified as HER2-positive (visible/high uptake) or HER2-negative (background/close to background activity). According to proportion of FDG-avid tumor load showing 89Zr-trastuzumab uptake (entire/dominant part or minor/no part), patients were classified as HER2-positive and HER2-negative, respectively. Out of 265 measurable lesions, 93 (35%) were HER2-negative, distributed among 42 of the 90 included patients. Of these, 18 (19%) lesions belonging to 11 patients responded anatomically (>30% decrease in axial diameter from baseline) after three T-DM1 cycles, resulting in an 81% negative predictive value (NPV) of the HER2 PET/CT. In combination with early metabolic response assessment on FDG PET/CT performed before the second T-DM1 cycle, NPVs of 91% and 100% were reached in predicting lesion-based and patient-based (RECIST1.1) response, respectively. Therefore, HER2 PET/CT, alone or in combination with early FDG PET/CT, can successfully identify BC lesions and patients with a low probability of clinical benefit from T-DM1.
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BACKGROUND AND OBJECTIVE: A notable paradigm shift has emerged in the choice of prostate biopsy approach, with a transition from transrectal biopsy (TRBx) to transperineal biopsy (TPBx) driven by the lower risk of severe urinary tract infections. The impact of this change on detection of clinically significant prostate cancer (csPCa) remains a subject of debate. Our aim was to compare the csPCa detection rate of TRBx and TPBx. METHODS: Patients who underwent magnetic resonance imaging (MRI)-targeted and systematic biopsies for clinically localized PCa at 15 European referral centers from 2016 to 2023 were included. A propensity score matching (PSM) analysis was performed to minimize selection biases. Logistic regression models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). KEY FINDINGS AND LIMITATIONS: Of 3949 patients who met the study criteria, 2187 underwent TRBx and 1762 underwent TPBx. PSM resulted in 1301 matched pairs for analysis. Patient demographics and tumor characteristics were comparable in the matched cohorts. TPBx versus TRBx was associated with greater detection of csPCa, whether defined as International Society of Urological Pathology grade group ≥2 (51% vs 45%; OR 1.37, 95% CI 1.15-1.63; p = 0.001) or grade group ≥3 (29% vs 23%; OR 1.38, 95% CI 1.13-1.67; p = 0.001). Similar results were found when considering MRI-targeted biopsy alone and after stratifying patients according to tumor location, Prostate Imaging-Reporting and Data System score, and clinical features. Limitations include the retrospective nature of the study and the absence of centralized MRI review. CONCLUSIONS: Our findings bolster existing understanding of the additional advantages offered by TPBx. Further randomized trials to fully validate these findings are awaited. PATIENT SUMMARY: We compared the rate of detection of clinically significant prostate cancer with magnetic resonance imaging (MRI)-guided biopsies in which the sample needle is passed through the perineum or the rectum. Our results suggest that the perineal approach is associated with better detection of aggressive prostate cancer.
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BACKGROUND: Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions, identified through multiparametric magnetic resonance imaging (mpMRI), present a clinical challenge due to their equivocal nature in predicting clinically significant prostate cancer (csPCa). Aim of the study is to improve risk stratification of patients with PI-RADS 3 lesions and candidates for prostate biopsy. METHODS: A cohort of 4841 consecutive patients who underwent MRI and subsequent MRI-targeted and systematic biopsies between January 2016 and April 2023 were retrospectively identified from independent prospectively maintained database. Only patients who have PI-RADS 3 lesions were included in the final analysis. A multivariable logistic regression analysis was performed to identify covariables associated with csPCa defined as International Society of Urological Pathology (ISUP) grade group ≥2. Performance of the model was evaluated using the area under the receiver operating characteristic curve (AUC), calibration, and net benefit. Significant predictors were then selected for further exploration using a Chi-squared Automatic Interaction Detection (CHAID) analysis. RESULTS: Overall, 790 patients had PI-RADS 3 lesions and 151 (19%) had csPCa. Significant associations were observed for age (OR: 1.1 [1.0-1.1]; p = 0.01) and PSA density (OR: 1643 [2717-41,997]; p < 0.01). The CHAID analysis identified PSAd as the sole significant factor influencing the decision tree. Cut-offs for PSAd were 0.13 ng/ml/cc (csPCa detection rate of 1% vs. 18%) for the two-nodes model and 0.09 ng/ml/cc and 0.16 ng/ml/cc for the three-nodes model (csPCa detection rate of 0.5% vs. 2% vs. 17%). CONCLUSIONS: For individuals with PI-RADS 3 lesions on prostate mpMRI and a PSAd below 0.13, especially below 0.09, prostate biopsy can be omitted, in order to avoid unnecessary biopsy and overdiagnosis of non-csPCa.
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BACKGROUND: Systematic biopsy (SB) combined with magnetic resonance imaging (MRI)-targeted biopsy is still recommended considering the risk of missing clinically significant prostate cancer (csPCa). OBJECTIVE: To evaluate the added value in csPCa detection on side-specific SB relative to MRI lesion and to externally validate the Noujeim risk stratification model that predicts the risk of csPCa on distant SB cores relative to the index MRI lesion. DESIGN, SETTING, AND PARTICIPANTS: Overall, 4841 consecutive patients diagnosed by MRI-targeted biopsy and SB for Prostate Imaging Reporting and Data System score ≥3 lesions were identified from a prospectively maintained database between January 2016 and April 2023 at 15 European referral centers. A total of 2387 patients met the inclusion criteria and were included in the analysis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: McNemar's test was used to compare the csPCa detection rate between several biopsy strategies including MRI-targeted biopsy, side-specific SB, and a combination of both. Model performance was evaluated in terms of discrimination using area under the receiver operation characteristic curve (AUC), calibration plots, and decision curve analysis. Clinically significant prostate cancer was defined as International Society of Urological Pathology grade group ≥2. RESULTS AND LIMITATIONS: Overall, the csPCa detection rate was 49%. Considering MRI-targeted biopsy as reference, the added values in terms of csPCa detection were 5.8% (relative increase of 13%), 4.2% (relative increase of 9.8%), and 2.8% (relative increase of 6.1%) for SB, ipsilateral SB, and contralateral SB, respectively. Only 35 patients (1.5%) exclusively had csPCa on contralateral SB (p < 0.001). Considering patients with csPCa on MRI-targeted biopsy and ipsilateral SB, the upgrading rate was 2% (20/961) using contralateral SB (p < 0.001). The Noujeim model exhibited modest performance (AUC of 0.63) when tested using our validation set. CONCLUSIONS: The added value of contralateral SB was negligible in terms of cancer detection and upgrading rates. The Noujeim model could be included in the decision-making process regarding the appropriate prostate biopsy strategy. PATIENT SUMMARY: In the present study, we collected a set of patients who underwent magnetic resonance imaging (MRI)-targeted and systematic biopsies for the detection of prostate cancer. We found that biopsies taken at the opposite side of the MRI suspicious lesion have a negligible impact on cancer detection. We also validate a risk stratification model that predicts the risk of cancer on biopsies beyond 10 mm from the initial lesion, which could be used in daily practice to improve the personalization of the prostate biopsy.
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BACKGROUND: The added-value of systematic biopsy (SB) in patients undergoing magnetic resonance imaging (MRI)-targeted biopsy (TB) remains unclear and the spatial distribution of positive cores relative to the MRI lesion has been poorly studied. The aim of this study was to determine the utility of perilesional biopsy in detecting clinically significant prostate cancer (csPCa). METHODS: We enrolled 505 consecutive patients that underwent SB and TB for suspicious MRI lesions (PI-RADS score 3-5) at Jules Bordet Institute between June 2016 and January 2022. Patient-specific tridimensional prostate maps were reviewed to determine the distance between systematic cores containing csPCa and the MRI index lesion. Primary outcomes were the cancer detection rate (CDR) per patient and the cumulative cancer distribution rate of positive cores for each 5 mm interval from the MRI index lesion. The secondary outcome was the identification of risk groups for the presence of csPCa beyond a 10 mm margin using the chi-square automated interaction detector (CHAID) machine learning algorithm. RESULTS: Overall, the CDR for csPCa of TB, SB, and combined method were 32%, 25%, and 37%, respectively. While combined method detected more csPCa compared to TB (37% vs. 32%, p < 0.001), no difference was found when TB was associated with perilesional sampling within 10 mm (37% vs. 35%, p = 0.2). The cumulative cancer distribution rate for csPCa reached 86% for the 10 mm margin. The CHAID algorithm identified three risk groups: (1) PI-RADS3 ("low-risk"), (2) PI-RADS4 or PI-RADS5 and PSA density <0.15 ng/ml ("intermediate-risk"), and (3) PI-RADS 5 and PSA density ≥0.15 ng/ml ("high-risk"). The risk of missing csPCa was 2%, 8%, and 29% for low-, intermediate- and high-risk groups, respectively. Avoiding biopsies beyond a 10 mm margin prevented the detection of 19% of non-csPCa. CONCLUSIONS: Perilesional biopsy template using a 10 mm margin seems a reasonable alternative to the combined method with a comparable detection of csPCa. Our risk stratification may further enhance the selection of patients.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Antígeno Prostático Específico , Imagen por Resonancia Magnética/métodos , Biopsia Guiada por Imagen/métodos , Estudios ProspectivosRESUMEN
Background: Increasing use of multiparametric magnetic resonance imaging (mpMRI) has come with heterogeneity in image quality. The Prostate Imaging Quality (PI-QUAL) score is under scrutiny to assess its usefulness in predicting clinical outcomes. Objective: To compare upstaging of localized disease on mpMRI (mrT2) to locally invasive disease in radical prostatectomy (RP) specimens (≥pT3a) in relation to PI-QUAL. Design setting and participants: Patients treated with RP between 2015 and 2020 who underwent 1.5-3-T mpMRI within 6 mo before surgery and had systematic and mpMRI-US targeted biopsies were included. mpMRI scans were retrospectively assigned a PI-QUAL score, and prospectively acquired Prostate Imaging-Recording and Data System (PI-RADS) scores (version 2.0 or 2.1) were used. PI-QUAL scores were categorized as nondiagnostic (PI-QUAL <3), sufficient (PI-QUAL 3), or optimal (PI-QUAL >3). Outcome measurements and statistical analysis: We assessed the relationship between the PI-QUAL score and upstaging using multivariate logistic regression. mpMRI, clinical, and pathological findings were compared using χ2 tests and analysis of variance. Results and limitations: We identified 351 patients, of whom 40 (11.4%) had PI-QUAL <3, 57 (16.3%) had PI-QUAL 3, and 254 (72.3%) had PI-QUAL >3 scores. The distribution of PI-QUAL <3 (0-33.6%; p < 0.001) and PI-QUAL >3 (37.3-100%; p < 0.001) scores varied widely among centers. PI-QUAL ≥3 in comparison to PI-QUAL <3 was associated with a lower rate of upstaging (19% vs 35%; p = 0.02), greater detection of mrT3a and mrT3b prostate cancer (17.0% vs 2.5%; p = 0.016), a higher rate of PI-RADS 5 lesions (47% vs 27.5%; p = 0.002), a higher number of suspicious lesion (PI-RADS ≥3: 34.7% vs 15%; p = 0.012), and higher detection rates for aggregated (50.7% vs 22.5%; p = 0.001) and late (21.2% vs 0%; p < 0.001) extraprostatic extension. On multivariate analysis, PI-QUAL<3 was associated with more frequent upstaging in the RP specimen (odds ratio 3.4; p = 0.01). Conclusions: In comparison to PI-QUAL ≥3, PI-QUAL <3 was significantly associated with a higher rate of upstaging from organ-confined disease on mpMRI to locally advanced disease on pathology, lower detection rates for PI-RADS 5 lesions and extraprostatic extension, and a lower number of suspicious lesions. Patient summary: Poor image quality for magnetic resonance imaging (MRI) scans of the prostate is associated with underestimation of the stage of prostate cancer.
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BACKGROUND: Accurate prediction of side-specific extraprostatic extension (ssEPE) is essential for performing nerve-sparing surgery to mitigate treatment-related side-effects such as impotence and incontinence in patients with localised prostate cancer. Artificial intelligence (AI) might provide robust and personalised ssEPE predictions to better inform nerve-sparing strategy during radical prostatectomy. We aimed to develop, externally validate, and perform an algorithmic audit of an AI-based Side-specific Extra-Prostatic Extension Risk Assessment tool (SEPERA). METHODS: Each prostatic lobe was treated as an individual case such that each patient contributed two cases to the overall cohort. SEPERA was trained on 1022 cases from a community hospital network (Trillium Health Partners; Mississauga, ON, Canada) between 2010 and 2020. Subsequently, SEPERA was externally validated on 3914 cases across three academic centres: Princess Margaret Cancer Centre (Toronto, ON, Canada) from 2008 to 2020; L'Institut Mutualiste Montsouris (Paris, France) from 2010 to 2020; and Jules Bordet Institute (Brussels, Belgium) from 2015 to 2020. Model performance was characterised by area under the receiver operating characteristic curve (AUROC), area under the precision recall curve (AUPRC), calibration, and net benefit. SEPERA was compared against contemporary nomograms (ie, Sayyid nomogram, Soeterik nomogram [non-MRI and MRI]), as well as a separate logistic regression model using the same variables included in SEPERA. An algorithmic audit was performed to assess model bias and identify common patient characteristics among predictive errors. FINDINGS: Overall, 2468 patients comprising 4936 cases (ie, prostatic lobes) were included in this study. SEPERA was well calibrated and had the best performance across all validation cohorts (pooled AUROC of 0·77 [95% CI 0·75-0·78] and pooled AUPRC of 0·61 [0·58-0·63]). In patients with pathological ssEPE despite benign ipsilateral biopsies, SEPERA correctly predicted ssEPE in 72 (68%) of 106 cases compared with the other models (47 [44%] in the logistic regression model, none in the Sayyid model, 13 [12%] in the Soeterik non-MRI model, and five [5%] in the Soeterik MRI model). SEPERA had higher net benefit than the other models to predict ssEPE, enabling more patients to safely undergo nerve-sparing. In the algorithmic audit, no evidence of model bias was observed, with no significant difference in AUROC when stratified by race, biopsy year, age, biopsy type (systematic only vs systematic and MRI-targeted biopsy), biopsy location (academic vs community), and D'Amico risk group. According to the audit, the most common errors were false positives, particularly for older patients with high-risk disease. No aggressive tumours (ie, grade >2 or high-risk disease) were found among false negatives. INTERPRETATION: We demonstrated the accuracy, safety, and generalisability of using SEPERA to personalise nerve-sparing approaches during radical prostatectomy. FUNDING: None.
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Inteligencia Artificial , Próstata , Masculino , Humanos , Estudios Retrospectivos , Prostatectomía , Medición de RiesgoRESUMEN
Objectives: The main objective of the study is to assess the feasibility and reproducibility of routine MRS to assist in the differential diagnosis between post-radiation necrosis and tumor progression. The secondary objective is to evaluate the accuracy of the method. Method: An additional sequence of MRS was added to the standard protocol routinely used for patient follow-up. To assess discomfort a control group was formed. The time required to perform MRS and analysis of results, and data about artefacts and technical limitations were collected. MRS results analyzed independently by two neuroradiologists were compared. The diagnostic accuracy of MRS was calculated using a composite reference standard. Results: The experimental group included 38 patients, the control group 41. The discomfort felt during the examination, is not significantly different between the groups. The average quality of SRM is rated as low. The frequency of cerebral radionecrosis is 13 % based on the reference standard used, 54 % and 46 % based on MRS results for the two observers. The additional time is 19,5 min. There is strong inter-observer agreement. The sensitivity and specificity of MRS are respectively for the diagnosis of radionecrosis of 60 % and 45 % (PPV = 16 %NPV = 87 %), for the diagnosis of tumor tissue of 25 % and 94 % (PPV = 80 %NPV = 57%). Conclusion: MRS is probably not applicable in routine clinical practice; however, in view of our results and the literature, in selected cases, it could be a support in the diagnosis of radionecrosis or brain tumor progression. Radionecrosis is probably underestimated.
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PURPOSE: To evaluate histopathologic upgrading between biopsy methods and whole-mount prostatectomy specimens in International Society of Urological Pathology grade group. METHODS: Overall, 134 patients, including 175 magnetic resonance imaging (MRI)-suspicious lesions, diagnosed on MRI-targeted (TB) and systematic (SB) biopsies before radical prostatectomy were retrospectively analyzed from a prospectively maintained database. Perilesional (PLB) and "extended" perilesional (ePLB) biopsies were defined as those taken within a circumferential zone of 5 and 10 mm around magnetic resonance imaging (MRI)-suspicious lesion respectively. Proportion of upgrading at prostatectomy pathology were compared between TB, TBâ¯+â¯PLB, TPâ¯+â¯ePLB and TBâ¯+â¯SB. Uni- and multivariable logistic regressions assessed predictors of upgrading for TBâ¯+â¯ePLB method. RESULTS: Focusing on index lesion, median (interquartile range) number of cores taken was 4 (3-4) for TB, 5 (4-6) for TBâ¯+â¯PLB, 6 (5-8) for TBâ¯+â¯ePLB and 12 (12-15) for TBâ¯+â¯SB. A higher upgrading proportion was detected upon comparing TB and TBâ¯+â¯PLB methods to TBâ¯+â¯SB (32 vs. 19%, Pâ¯=â¯0.001, 26 vs. 19%, Pâ¯=â¯0.04, respectively). Conversely, no significant difference was found between TBâ¯+â¯ePLB compared to TBâ¯+â¯SB (23 vs. 19%, Pâ¯=â¯0.2). Proportion of downgrading was similar regardless of biopsy method (all P > 0.1). At multivariable analysis, Prostate Imaging-Reporting and Data System Steering score, total number of positive ePLB cores and International Society of Urological Pathology Grade Group were independent predictors of upgrading (all P ≤ 0.03). Similar results were found by adding data from non-index lesions. CONCLUSION: Our finding suggest that MRI-targeted biopsies associated with perilesional sampling in a circumferential zone of 10 mm reduced upgrading proportion and showed similar accuracy as the current gold standard combination. Further prospective studies comparing biopsy methods are expected to validate this diagnostic strategy.
Asunto(s)
Próstata , Neoplasias de la Próstata , Biopsia/métodos , Humanos , Biopsia Guiada por Imagen/métodos , Imagen por Resonancia Magnética , Masculino , Clasificación del Tumor , Estudios Prospectivos , Próstata/diagnóstico por imagen , Próstata/patología , Próstata/cirugía , Prostatectomía/métodos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) is often used to provide nutritional support in locally advanced head and neck cancer patients undergoing multimodality treatment. However, there is little published data on the impact of prophylactic versus reactive PEG. PEG placement may affect swallowing-related physiology, function, and quality of life. The Swall PEG study is a randomized controlled phase III trial testing the impact of prophylactic versus reactive PEG on patient-reported outcomes in terms of swallowing and quality of life in oropharyngeal cancer patients. METHODS: Patients with locally advanced oropharyngeal cancer receiving chemo-radiotherapy will be randomized to either the prophylactic or reactive PEG tube group. Randomization will be stratified by human papillomavirus (HPV) status and unilateral versus bilateral positive neck lymph nodes. The primary objective of the study is the patient's reported outcome in terms of swallowing (MD Anderson Dysphagia Inventory (MDADI)) at 6 months. Secondary objectives include health-related quality of life, dosimetric parameters associated with patient-reported outcomes, chemo-radiation toxicities, PEG tube placement complications, the impact of nutritional status on survival and toxicity outcomes, loco-regional control, overall survival, the impact of HPV and tobacco smoking on survival outcomes and toxicities, and the cost-effectiveness of each treatment strategy. DISCUSSION: Findings from this study will enhance clinical evidence regarding nutritional management in oropharyngeal cancer patients treated by concurrent chemo-radiation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04019548, study protocol version 2.0_08/08/2019. Registered on 15 July 2019.