Evaluating Complete Response Rates and Predictors in Total Neoadjuvant Therapy for Rectal Cancer.

INTRODUCTION: In the management of locally advanced rectal cancer (LARC), there is a paradigm shift from conventional neoadjuvant treatment to total neoadjuvant therapy (TNT). Despite its growing acceptance, there are limited studies have examined its effects on disease presentation. It is also important to determine the factors that play a role in complete response (CR). Our previous data with 119 patients revealed that the CR rate was 37%, and low rectal tumors and the absence of extramural vascular invasion (EMVI) were predictors of CR. Unfortunately, there continues to be a lack of data, and reliable markers are still needed to consistently identify the best respondents. Therefore, we aimed to determine factors associated with CR. We hypothesized that due to the growing patient population, both predictive factors and CR ratio might evolve over time. METHODS: A retrospective analysis of patients who completed TNT for LARC at our tertiary care center between 2015 and 2022 was performed. Our primary outcome was to determine predictors of CR. As a secondary outcome, we evaluated the 2-year disease-free and overall survival rates. CR consists of patients who sustained clinical CR (cCR) for at least 12 months under WW or had pathological CR (pCR) after surgery. RESULTS: Out of 339 patients with LARC, 208 (61.3%) successfully completed TNT. Among them, 57 (27.4%) patients achieved cCR, and 80% sustained without tumor regrowth after a year. The remaining 151 (72.6%) patients underwent surgery, and 42 had pCR. The final CR rate was 42.3%. The median age of the patients was 56 (49-66), and 63.5% of the participants were male (n=132), while 36.5% were female (n=76). The median tumor size was 4.95cm (3.6-6.43), with most tumors in the low rectum (119, 57.2%). The MRF involvement rate was 25% (n=52), and EMVI was observed in 20.7% of patients (n=43). based on MRI findings. Low rectal tumors, the absence of MRF involvement, and the absence of EMVI were predicted CR. With a median follow-up of 24.7 months, 2-year disease-free survival and overall survival were significantly higher among patients with CR (91.3% vs 71%, p<0.01 and 98.8% vs 90.2% p=0.03, respectively). CONCLUSION: In our updated dataset, we observed an increasing CR rate compared to our previous study. In addition to previously identified predictors, low tumor location and the absence of EMVI, we also found the absence of MRF involvement as a predictor of CR. These findings offer valuable insights for clinical practice, helping clinicians set clear expectations when counseling patients.

Improving Prostate MR Image Quality in Practice-Initial Results From the ACR Prostate MR Image Quality Improvement Collaborative.

OBJECTIVE: Variability in prostate MRI quality is an increasingly recognized problem that negatively affects patient care. This report aims to describe the results and key learnings of the first cohort of the ACR Learning Network Prostate MR Image Quality Improvement Collaborative. METHODS: Teams from five organizations in the United States were trained on a structured improvement method. After reaching a consensus on image quality and auditing their images using the Prostate Imaging Quality (PI-QUAL) system, teams conducted a current state analysis to identify barriers to obtaining high-quality images. Through plan-do-study-act cycles involving frontline staff, each site designed and tested interventions targeting image quality key drivers. The percentage of examinations meeting quality criteria (ie, PI-QUAL score ≥4) was plotted on a run chart, and project progress was reviewed in weekly meetings. At the collaborative level, the goal was to increase the percentage of examinations with PI-QUAL ≥4 to at least 85%. RESULTS: Across 2,380 examinations audited, the mean weekly rates of prostate MR examinations meeting image quality criteria increased from 67% (range: 60%-74%) at baseline to 87% (range: 80%-97%) upon program completion. The most commonly employed interventions were MR protocol adjustments, development and implementation of patient preparation instructions, personnel training, and development of an auditing process mechanism. CONCLUSION: A learning network model, in which organizations share knowledge and work together toward a common goal, can improve prostate MR image quality at multiple sites simultaneously. The inaugural cohort's key learnings provide a road map for improvement on a broader scale.

PI-QUAL version 2: an update of a standardised scoring system for the assessment of image quality of prostate MRI.

Multiparametric MRI is the optimal primary investigation when prostate cancer is suspected, and its ability to rule in and rule out clinically significant disease relies on high-quality anatomical and functional images. Avenues for achieving consistent high-quality acquisitions include meticulous patient preparation, scanner setup, optimised pulse sequences, personnel training, and artificial intelligence systems. The impact of these interventions on the final images needs to be quantified. The prostate imaging quality (PI-QUAL) scoring system was the first standardised quantification method that demonstrated the potential for clinical benefit by relating image quality to cancer detection ability by MRI. We present the updated version of PI-QUAL (PI-QUAL v2) which applies to prostate MRI performed with or without intravenous contrast medium using a simplified 3-point scale focused on critical technical and qualitative image parameters. CLINICAL RELEVANCE STATEMENT: High image quality is crucial for prostate MRI, and the updated version of the PI-QUAL score (PI-QUAL v2) aims to address the limitations of version 1. It is now applicable to both multiparametric MRI and MRI without intravenous contrast medium. KEY POINTS: High-quality images are essential for prostate cancer diagnosis and management using MRI. PI-QUAL v2 simplifies image assessment and expands its applicability to prostate MRI without contrast medium. PI-QUAL v2 focuses on critical technical and qualitative image parameters and emphasises T2-WI and DWI.

True-Positive 18F-Flotufolastat Lesions in Patients with Prostate Cancer Recurrence with Baseline-Negative Conventional Imaging: Results from the Prospective, Phase 3, Multicenter SPOTLIGHT Study.

18F-rhPSMA-7.3 (18F-flotufolastat) is a high-affinity prostate-specific membrane antigen-targeted diagnostic radiopharmaceutical for PET imaging in patients with prostate cancer. Here, we report findings from the SPOTLIGHT study (NCT04186845), assessing the performance of 18F-flotufolastat PET/CT for identifying prostate-specific membrane antigen-positive lesions confirmed by standard of truth (SoT) in men with biochemical recurrence of prostate cancer and negative conventional imaging at baseline. Methods: Men with biochemical recurrence received 296 MBq of 18F-flotufolastat intravenously and then underwent PET/CT 50-70 min later. 18F-flotufolastat PET/CT findings were evaluated by 3 masked central readers and verified using histopathology or follow-up confirmatory imaging (CT, MRI, bone scan, or 18F-fluciclovine PET/CT) as the SoT. The present analysis evaluated all patients who had negative conventional imaging at baseline, underwent 18F-flotufolastat PET/CT, and had SoT verification by histopathology or follow-up confirmatory imaging to report detection rate (DR), which is the number of patients with at least 1 PET-positive lesion, divided by the number of evaluable patients, and verified DR (VDR), which is the proportion of patients with at least 1 true-positive lesion as verified by SoT, of all patients scanned (PET-positive and PET-negative scans). DR and VDR were calculated and stratified according to prior therapy. Majority read data (agreement between ≥2 readers) are reported. Results: In total, 171 patients with negative baseline conventional imaging and SoT by histopathology or post-PET confirmatory imaging were evaluated. By majority read, the overall 18F-flotufolastat DR among these patients was 95% (163/171; 95% CI, 91.0%-98.0%), and 110 of 171 of these patients had at least 1 true-positive lesion identified (VDR, 64%; 95% CI, 56.7%-71.5%). In the postprostatectomy group (133/171), 8.3% of patients had at least 1 true-positive lesion in the prostate bed, 28% in pelvic lymph nodes, and 35% in other sites. Among those who had received radiotherapy (36/171), 50% of patients had true-positive detections in the prostate, 8.3% in pelvic lymph nodes, and 36% in other sites. Conclusion: 18F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging. 18F-flotufolastat may help to better define sites of disease recurrence and inform salvage therapy decisions than does conventional imaging, potentially leading to improved outcomes.

New Prostate MRI Scoring Systems (PI-QUAL, PRECISE, PI-RR, and PI-FAB): AJR Expert Panel Narrative Review.

Multiparametric MRI (mpMRI), interpreted using PI-RADS, improves the initial detection of clinically significant prostate cancer (PCa). Prostate MR image quality has increasingly recognized relevance to the use of mpMRI for PCa diagnosis. Additionally, mpMRI is increasingly used in scenarios beyond initial detection, including active surveillance and assessment for local recurrence after prostatectomy, radiation therapy, or focal therapy. Acknowledging these evolving demands, specialized prostate MRI scoring systems beyond PI-RADS have emerged, to address distinct scenarios and unmet needs. Examples include Prostate Imaging Quality (PI-QUAL) for assessment of image quality of mpMRI, Prostate Cancer Radiologic Estimation of Change in Sequential Evaluation (PRECISE) recommendations for evaluation of serial mpMRI examinations during active surveillance, Prostate Imaging for Recurrence Reporting System (PI-RR) for assessment for local recurrence after prostatectomy or radiation therapy, and Prostate Imaging after Focal Ablation (PI-FAB) for assessment for local recurrence after focal therapy. These systems' development and early uptake signal a compelling shift towards prostate MRI standardization in different scenarios, and ongoing research will help refine their roles in practice. This AJR Expert Panel Narrative Review critically examines these new prostate MRI scoring systems (PI-QUAL, PRECISE, PI-RR, and PI-FAB), analyzing the available evidence, delineating current limitations, and proposing solutions for improvement.

Enhancing prostate MRI expertise: educational strategies for radiologists.

The adoption of multiparametric MRI (mpMRI) and the Prostate Imaging Reporting and Data System has significantly changed prostate cancer diagnosis and management. These advancements, alongside novel biomarkers and updated International Society of Uropathology grade groups, have improved cancer detection and prognostication. Despite this progress, varying levels of expertise in mpMRI among radiologists have resulted in inconsistent assessments, potentially leading to unnecessary procedures and diminished confidence in the modality. This review assesses the educational landscape for prostate MRI, highlighting available resources for radiologists at all professional stages. It emphasizes the need for targeted educational strategies to bridge knowledge gaps and improve patient care outcomes in prostate cancer management.

PRECISE Version 2: Updated Recommendations for Reporting Prostate Magnetic Resonance Imaging in Patients on Active Surveillance for Prostate Cancer.

BACKGROUND AND OBJECTIVE: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations standardise the reporting of prostate magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer. An international consensus group recently updated these recommendations and identified the areas of uncertainty. METHODS: A panel of 38 experts used the formal RAND/UCLA Appropriateness Method consensus methodology. Panellists scored 193 statements using a 1-9 agreement scale, where 9 means full agreement. A summary of agreement, uncertainty, or disagreement (derived from the group median score) and consensus (determined using the Interpercentile Range Adjusted for Symmetry method) was calculated for each statement and presented for discussion before individual rescoring. KEY FINDINGS AND LIMITATIONS: Participants agreed that MRI scans must meet a minimum image quality standard (median 9) or be given a score of 'X' for insufficient quality. The current scan should be compared with both baseline and previous scans (median 9), with the PRECISE score being the maximum from any lesion (median 8). PRECISE 3 (stable MRI) was subdivided into 3-V (visible) and 3-NonV (nonvisible) disease (median 9). Prostate Imaging Reporting and Data System/Likert ≥3 lesions should be measured on T2-weighted imaging, using other sequences to aid in the identification (median 8), and whenever possible, reported pictorially (diagrams, screenshots, or contours; median 9). There was no consensus on how to measure tumour size. More research is needed to determine a significant size increase (median 9). PRECISE 5 was clarified as progression to stage ≥T3a (median 9). CONCLUSIONS AND CLINICAL IMPLICATIONS: The updated PRECISE recommendations reflect expert consensus opinion on minimal standards and reporting criteria for prostate MRI in AS. PATIENT SUMMARY: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations are used in clinical practice and research to guide the interpretation and reporting of magnetic resonance imaging for patients on active surveillance for prostate cancer. An international panel has updated these recommendations, clarified the areas of uncertainty, and highlighted the areas for further research.

PI-RADS Upgrading Rules: Impact on Prostate Cancer Detection and Biopsy Avoidance of MRI-Directed Diagnostic Pathways.

BACKGROUND. PI-RADS incorporates rules by which ancillary sequence findings upgrade a dominant score to a higher final category. Evidence on the upgrading rules' impact on diagnostic pathways remains scarce. OBJECTIVE. The purpose of this article was to evaluate the clinical net benefit of the PI-RADS upgrading rules in MRI-directed diagnostic pathways. METHODS. This study was a retrospective analysis of a prospectively maintained clinical registry. The study included patients without known prostate cancer who underwent prostate MRI followed by prostate biopsy from January 2016 to May 2020. Clinically significant prostate cancer (csPCa) was defined as International Society of Urological Pathology (ISUP) grade group 2 and higher. csPCa detection was compared between dominant (i.e., no upgrade rule applied) and upgraded lesions. Decision-curve analysis was used to compare the net benefit, considering the trade-off of csPCa detection and biopsy avoidance, of MRI-directed pathways in scenarios considering and disregarding PI-RADS upgrading rules. These included a biopsy-all pathway, MRI-focused pathway (no biopsy for PI-RADS ≤ 2), and risk-based pathway (use of PSA density ≥ 0.15 ng/mL2 to select patients with PI-RADS ≤ 3 for biopsy). RESULTS. The sample comprised 716 patients (mean age, 64.9 years; 93 with a PI-RADS ≤ 2 examination, 623 with total of 780 PI-RADS ≥ 3 lesions). Frequencies of csPCa were not significantly different between dominant and upgraded PI-RADS 3 transition zone lesions (20% vs 19%, respectively), dominant and upgraded PI-RADS 4 transition zone lesions (33% vs 26%), and dominant and upgraded PI-RADS 4 peripheral zone lesions (58% vs 45%) (p > .05). In the biopsy-all, per-guideline MRI-focused, MRI-focused disregarding upgrading rules, per-guideline risk-based, and risk-based disregarding upgrading rules pathways, csPCa frequency was 53%, 52%, 51%, 52%, and 48% and biopsy avoidance was 0%, 13%, 16%, 19%, and 25%, respectively. Disregarding upgrading rules yielded 5.5 and 1.9 biopsies avoided per missed csPCa for MRI-focused and risk-based pathways, respectively. At probability thresholds for biopsy selection of 7.5-30.0%, net benefit was highest for the per-guideline risk-based pathway. CONCLUSION. Disregarding PI-RADS upgrading rules reduced net clinical bene fit of the risk-based MRI-directed diagnostic pathway when considering trade-offs between csPCa detection and biopsy avoidance. CLINICAL IMPACT. This study supports the application of PI-RADS upgrading rules to optimize biopsy selection, particularly in risk-based pathways.

Quality of T2-weighted MRI re-acquisition versus deep learning GAN image reconstruction: A multi-reader study.

PURPOSE: To evaluate CycleGAN's ability to enhance T2-weighted image (T2WI) quality. METHOD: A CycleGAN algorithm was used to enhance T2WI quality. 96 patients (192 scans) were identified from patients who underwent multiple axial T2WI due to poor quality on the first attempt (RAD1) and improved quality on re-acquisition (RAD2). CycleGAN algorithm gave DL classifier scores (0-1) for quality quantification and produced enhanced versions of QI1 and QI2 from RAD1 and RAD2, respectively. A subset (n = 20 patients) was selected for a blinded, multi-reader study, where four radiologists rated T2WI on a scale of 1-4 for quality. The multi-reader study presented readers with 60 image pairs (RAD1 vs RAD2, RAD1 vs QI1, and RAD2 vs QI2), allowing for selecting sequence preferences and quantifying the quality changes. RESULTS: The DL classifier correctly discerned 71.9 % of quality classes, with 90.6 % (96/106) as poor quality and 48.8 % (42/86) as diagnostic in original sequences (RAD1, RAD2). CycleGAN images (QI1, QI2) demonstrated quantitative improvements, with consistently higher DL classifier scores than original scans (p < 0.001). In the multi-reader analysis, CycleGAN demonstrated no qualitative improvements, with diminished overall quality and motion in QI2 in most patients compared to RAD2, with noise levels remaining similar (8/20). No readers preferred QI2 to RAD2 for diagnosis. CONCLUSION: Despite quantitative enhancements with CycleGAN, there was no qualitative boost in T2WI diagnostic quality, noise, or motion. Expert radiologists didn't favor CycleGAN images over standard scans, highlighting the divide between quantitative and qualitative metrics.

Restless legs syndrome in patients on chronic hemodialysis in a Brazilian city: frequency, biochemical findings and comorbidities

OBJECTIVE: To evaluate the frequency of restless legs syndrome (RLS) in patients with chronic renal failure (CRF) in Petrópolis, Brazil, and investigate associations between the syndrome and: demographic characteristics, biochemical variables and comorbidities. METHOD: A cross-sectional study in which we interviewed 176 patients on dialytic therapy based on criteria elaborated by the International Restless Legs Syndrome Study Group, and compared data of patients with and without RLS. RESULTS: The frequency was 14.8 percent. There were no significant differences between the two groups in demographic and biochemical variables investigated (iron, creatinine, intact parathyroid hormone, hemoglobin, calcium, phosphate). We found no association between RLS and the most common comorbidities, except for chronic glomerulonephritis (CGN) (OR = 3.84, p < 0.01). CONCLUSION: In the studied population RLS is a common disorder, and is not associated with the investigated biochemical abnormalities. A higher frequency of RLS in subjects with CGN is a finding that needs further investigation