IMPORTANCE: High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis. OBJECTIVE: To compare microultrasonography-guided and MRI fusion-guided biopsy. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, international, open-label, randomized, noninferiority trial of biopsy-naive men from 20 centers (8 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and/or abnormal digital rectal examination findings) from December 2021 to September 2024. INTERVENTIONS: Participants were assigned to receive either microultrasonography-guided biopsy (n = 121), microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI; n = 226, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography; n = 331). All participants received synchronous systematic biopsy. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers using microultrasonography plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The secondary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers found using microultrasonography/MRI plus systematic biopsy vs MRI/conventional ultrasonography plus systematic biopsy. The noninferiority margin was set at 10%. RESULTS: A total of 802 men underwent randomization and 678 underwent biopsy. Median (IQR) age was 65 (59-70) years and prostate-specific antigen level was 6.9 (5.2-9.8) ng/mL; 83% self-identified as White. Gleason Grade Group 2 or higher cancer was detected in 57 participants (47.1%) in the microultrasonography group, in 141 (42.6%) in the MRI/conventional ultrasonography group, and in 106 (46.9%) in the microultrasonography/MRI group. Microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy (difference, 3.52% [95% CI, -3.95% to 10.92%]; noninferiority P < .001). Combined biopsy with microultrasonography/MRI was also noninferior to MRI/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29% [95% CI, -4.06% to 12.63%]; noninferiority P < .001). The rate of Gleason Grade Group 2 or higher cancer diagnosed by targeted biopsy only was 38.0% in the microultrasonography group, 34.1% in the MRI/conventional ultrasonography group, and 40.3% in the microultrasonography/MRI group; these differences were not significant. CONCLUSIONS AND RELEVANCE: The use of microultrasonography-guided biopsy was noninferior to MRI/conventional ultrasonography fusion-guided biopsy for the detection of Gleason Grade Group 2 or higher prostate cancer in biopsy-naive men. Microultrasonography may provide an alternative to MRI for image-guided prostate biopsy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05220501.
- MeSH
- intervenční ultrasonografie * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonance intervenční * MeSH
- multimodální zobrazování metody MeSH
- nádory prostaty * krev diagnóza patologie MeSH
- palpační vyšetření konečníku MeSH
- prostata * patologie diagnostické zobrazování MeSH
- prostatický specifický antigen krev MeSH
- senioři MeSH
- stupeň nádoru MeSH
- ultrazvukem navigovaná biopsie * metody MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- srovnávací studie MeSH
PURPOSE: To evaluate the value of examination under anesthesia (EUA) in the assessment of bladder resectability during cystectomy. MATERIALS AND METHODS: This prospective study included consecutive patients undergoing cystectomy for bladder cancer at a single center between June 2017 and October 2020. EUA was conducted before cystectomy by two urologists who assessed the bladder for limited mobility. One examiner was blinded to the imaging results. Soft tissue surgical margin status in the pathological evaluation of a cystectomy specimen served as a measure of resectability. We used multivariable logistic regression models to assess whether EUA performed by blinded or non-blinded examiners is associated with soft tissue positive surgical margins (PSMs) and to calculate the fraction of new information added by such an examination in addition to selected clinical variables. RESULTS: Among the 134 patients analyzed, limited bladder mobility was indicated by the blinded and non-blinded examiners in 23 (17.2%) and 21 (15.7%) cases, respectively. PSMs were identified in 22 (16.4%) patients, more often in patients with limited bladder mobility as assessed by the blinded (odds ratio [OR] 6.7; 95% confidence interval [CI], 1.9-24.2) and non-blinded examiners (OR 12.9; 95% CI, 2.9-57.5). The fraction of new information added by the blinded and non-blinded examiners was 48.6% and 57.7%, respectively. The enrichment of patients who underwent pure laparoscopic cystectomy (n = 102; 76%) and the inclusion of patients for emergent surgery may limit the generalizability of our findings. CONCLUSIONS: The identification of limited bladder mobility during preoperative EUA yielded prognostic information on surgical margin status. Our findings suggest that EUA has the potential to provide valuable insights in the assessment of bladder resectability. However, further research in a larger cohort of patients is warranted to validate and expand on these findings.
- MeSH
- cystektomie * metody MeSH
- laparoskopie * metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory močového měchýře * chirurgie patologie MeSH
- palpace * MeSH
- prospektivní studie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND AND OBJECTIVE: Although digital rectal examination (DRE) is recommended in combination with prostate-specific antigen (PSA) for detection of prostate cancer (PCa), there are limited data to support its use as a screening/early detection test. Our objective was to assess the diagnostic value of DRE in screening for early detection of PCa. METHODS: In August 2023, we queried the PubMed, Scopus, and Web of Science databases to identify prospective studies simultaneously investigating the diagnostic performance of DRE and PSA for PCa screening. The primary endpoints were the positive predictive value (PPV) and cancer detection rate (CDR) of DRE. Secondary endpoints included the PPV and CDR of both PSA alone and in combination with DRE. We conducted meta-regression analysis to compare the CDR and PPV of different screening strategies. This meta-analysis is registered on PROSPERO (CRD42023446940). KEY FINDINGS AND LIMITATIONS: We identified eight studies involving 85,798 participants, of which three were randomized controlled trials and five were prospective diagnostic studies, that reported the PPV and CDR of both DRE and PSA for the same cohort. Our analysis revealed a pooled PPV of 0.21 (95% confidence interval [CI] 0.13-0.33) for DRE, which is similar to the PPV of PSA (0.22, 95% CI 0.15-0.30; p = 0.9), with no benefit from combining DRE and PSA (PPV 0.19, 95% CI 0.13-0.26; p = 0.5). However, the CDR of DRE (0.01, 95% CI: 0.01-0.02) was significantly lower than that of PSA (0.03, 95% CI 0.02-0.03; p < 0.05) and the combination of DRE and PSA (0.03, 95% CI 0.02-0.04; p < 0.05). The screening strategy combining DRE and PSA was not different to that of PSA alone in terms of CDR (p = 0.5) and PPV (p = 0.5). CONCLUSIONS AND CLINICAL IMPLICATIONS: Our comprehensive review and meta-analysis indicates that both as an independent test and as a supplementary measure to PSA for PCa detection, DRE exhibits a notably low diagnostic value. The collective findings from the included studies suggest that, in the absence of clinical symptoms and signs, DRE could be potentially omitted from PCa screening and early detection strategies. PATIENT SUMMARY: Our review shows that the screening performance of digital rectal examination for detection of prostate cancer is not particularly impressive, suggesting that it might not be necessary to conduct this examination routinely.
- MeSH
- časná detekce nádoru * metody MeSH
- lidé MeSH
- nádory prostaty * diagnóza krev MeSH
- palpační vyšetření konečníku * MeSH
- prostatický specifický antigen * krev MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- srovnávací studie MeSH
- systematický přehled MeSH
"Muscle tone" is a clinically important and widely used term and palpation is a crucial skill for its diagnosis. However, the term is defined rather vaguely, and palpation is not measurable objectively. Therefore, several methods have been developed to measure muscle tone objectively, in terms of biomechanical properties of the muscle. This article aims to summarize these approaches. Through database searches, we identified those studies related to objective muscle tone measurement in vivo, in situ. Based on them, we described existing methods and devices and compared their reliability. Furthermore, we presented an extensive list of the use of these methods in different fields of research. Although it is believed by some authors that palpation cannot be replaced by a mechanical device, several methods have already proved their utility in muscle biomechanical property diagnosis. There appear to be two issues preventing wider usage of these objective methods in clinical practice. Firstly, a high variability of their reliability, and secondly, a lack of valid mathematical models that would provide the observed mechanical characteristics with a clear physical significance and allow the results to be compared with each other.
- MeSH
- databáze faktografické MeSH
- palpace MeSH
- reprodukovatelnost výsledků MeSH
- svalový tonus * MeSH
- svaly * MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
OBJECTIVES: To prospectively assess the concordance of examination under anesthesia (EUA)-based clinical T stage with pathological T stage and diagnostic accuracy of EUA in patients with bladder cancer undergoing cystectomy. METHODS: Consecutive patients with bladder cancer undergoing cystectomy between June 2017 and October 2020 in a single academic center were included in a prospective study. Two urologists performed EUA (one blinded to imaging) before patients underwent cystectomy. We assessed the concordance between clinical T stage in bimanual palpation (index test) and pathological T stage in cystectomy specimens (reference test). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with 95% confidence intervals (CIs) to detect or exclude locally advanced bladder cancer (pT3b-T4b) in EUA. RESULTS: The data of 134 patients were analyzed. Given that stage pT3a cannot be palpated, for the nonblinded examiner, T staging in EUA was concordant with pT in 107 (79.9%) patients, 20 (14.9%) cases being understaged in EUA and 7 (5.2%) overstaged. For the blinded examiner, staging was correct in 106 (79.1%) patients, 20 (14.9%) cases being understaged and 8 (6%) overstaged. For the nonblinded examiner, sensitivity, specificity, PPV, and NPV of EUA were 55.9% (95% CI 39.2%-72.6%), 93% (88%-98%), 73.1% (56%-90.1%), and 86.1% (79.6%-92.6%), respectively; for the blinded examiner, they were 52.9% (36.2%-69.7%), 93% (88%-98%), 72% (54.4%-89.6%) and 85.3% (78.7%-92%), respectively. Awareness of imaging results did not have a major impact on EUA results. CONCLUSION: Bimanual palpation should still be used for clinical staging, given its specificity, NPV, and that it could correctly determine bladder cancer T stage in 80% of cases.
- MeSH
- bolest - postupné ovlivňování fyziologie MeSH
- bolest ramene * diagnóza etiologie MeSH
- diferenciální diagnóza MeSH
- lidé MeSH
- palpace metody MeSH
- pojivová tkáň patofyziologie MeSH
- ramenní kloub patofyziologie MeSH
- reflexní terapie metody MeSH
- techniky fyzikální terapie MeSH
- viscerální bolest * diagnóza rehabilitace MeSH
- vnitřnosti patofyziologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
