Dataset Information

Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category.

ABSTRACT:

Background

Prostate Imaging-Reporting and Data System (PI-RADS) category 3 is a challenging scenario for detection of clinically significant prostate cancer (csPCa) and some tools can improve the selection of appropriate candidates for prostate biopsy.

Objective

To assess the performance of the European Randomized Study of Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI) model, the new Proclarix test, and prostate-specific antigen density (PSAD) in selecting candidates for prostate biopsy among men in the PI-RADS 3 category.

Design setting and participants

We conducted a head-to-head prospective analysis of 567 men suspected of having PCa for whom guided and systematic biopsies were scheduled between January 2018 and March 2020 in a single academic institution. A PI-RADS v.2 category 3 lesion was identified in 169 men (29.8%).

Outcome measurement and statistical analysis

csPCa, insignificant PCa (iPCa), and unnecessary biopsy rates were analysed. csPCa was defined as grade group ≥2. Receiver operating characteristic (ROC) curves, decision curve analysis curves, and clinical utility curves were plotted.

Results and limitations

PCa was detected in 53/169 men (31.4%) with a PI-RADS 3 lesion, identified as csPCa in 25 (14.8%) and iPCa in 28 (16.6%). The area under the ROC curve for csPCa detection was 0.703 (95% confidence interval [CI] 0.621-0.768) for Proclarix, 0.657 (95% CI 0.547-0.766) for the ERSPC MRI model, and 0.612 (95% CI 0.497-0.727) for PSAD (p = 0.027). The threshold with the highest sensitivity was 10% for Proclarix, 1.5% for the ERSPC MRI model, and 0.07 ng/ml/cm³ for PSAD, which yielded sensitivity of 100%, 91%, and 84%, respectively. Some 21.3%, 26.2%, and 7.1% of biopsies would be avoided with Proclarix, PSAD, and the ERSPC MRI model, respectively. Proclarix showed a net benefit over PSAD and the ERSPC MRI model. Both Proclarix and PSAD reduced iPCa overdetection from 16.6% to 11.3%, while the ERSPC MRI model reduced iPCa overdetection to 15.4%.

Conclusions

Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model. Proclarix detected 100% of csPCa cases and would reduce prostate biopsies by 21.3% and iPCa overdetection by 5.3%.

Patient summary

We compared three methods and found that the Proclarix test can optimise the detection of clinically significant prostate cancer in men with a score of 3 on the Prostate Imaging-Reporting and Data System for magnetic resonance imaging scans.

SUBMITTER: Morote J

PROVIDER: S-EPMC8883194 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category.

Morote Juan J Campistol Miriam M Triquell Marina M Celma Anna A Regis Lucas L de Torres Inés I Semidey Maria E ME Mast Richard R Santamaria Anna A Planas Jacques J Trilla Enrique E

European urology open science 20220123

<h4>Background</h4>Prostate Imaging-Reporting and Data System (PI-RADS) category 3 is a challenging scenario for detection of clinically significant prostate cancer (csPCa) and some tools can improve the selection of appropriate candidates for prostate biopsy.<h4>Objective</h4>To assess the performance of the European Randomized Study of Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI) model, the new Proclarix test, and prostate-specific antigen density (PSAD) in selecting ...[more]

PMID: 35243388

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Project description:PurposeGiven the limitations of prostate specific antigen and standard biopsies for detecting prostate cancer, we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health.Materials and methodsWe performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between 2012 and 2013. A total of 153 men consented to the study and underwent 3 Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer. Lesions were classified as low or moderate/high risk for prostate cancer. Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and standard 12-core prostate biopsy were performed and 105 men were eligible for analysis.ResultsMean patient age was 65.8 years and mean prostate specific antigen was 9.5 ng/ml. The overall cancer detection rate was 62.9% (66 of 105 patients). The cancer detection rate in those with moderate/high risk on imaging was 72.3% (47 of 65) vs 47.5% (19 of 40) in those classified as low risk for prostate cancer (p<0.05). Mean tumor core length was 4.6 and 3.7 mm for fusion biopsy and standard 12-core biopsy, respectively (p<0.05). Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by standard 12-core biopsy in 14.3% of cases (15 of 105), of which 86.7% (13 of 15) were clinically significant. This biopsy upgraded 23.5% of cancers (4 of 17) deemed clinically insignificant on 12-core biopsy to clinically significant prostate cancer necessitating treatment.ConclusionsMagnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection. The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management.

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

Project description:ObjectiveAssess radiologists' contribution to variation in clinically significant prostate cancer (csPCa) detection in patients with elevated prostate-specific antigen (PSA) and multiparametric MRI (mpMRI).MethodsThis institutional review board-approved, retrospective cohort study was performed at a tertiary, academic, National Cancer Institute-designated Comprehensive Cancer Center with a multidisciplinary prostate cancer program. Men undergoing mpMRI examinations from January 1, 2015, to December 31, 2019, with elevated PSA (≥4 ng/mL) and biopsy within 6 months pre- or post-MRI or prostatectomy within 6 months post-mpMRI were included. Univariate and multivariable hierarchical logistic regression assessed impact of patient, provider, mpMRI examination, mpMRI report, and pathology factors on the diagnosis of Grade Group ≥ 2 csPCa.ResultsStudy cohort included 960 MRIs in 928 men, mean age 64.0 years (SD ± 7.4), and 59.8% (555 of 928) had csPCa. Interpreting radiologist was not significant individually (P > .999) or combined with mpMRI ordering physician and physician performing biopsy or prostatectomy (P = .41). Prostate Imaging Reporting and Data System (PI-RADS) category 2 (odds ratio [OR] 0.18, P = .04), PI-RADS category 4 (OR 2.52, P < .001), and PI-RADS category 5 (OR 4.99, P < .001) assessment compared with no focal lesion; PSA density of 0.1 to 0.15 ng/mL/cc (OR 2.46, P < .001), 0.15 to 0.2 ng/mL/cc (OR 2.77, P < .001), or ≥0.2 ng/mL/cc (OR 4.52, P < .001); private insurance (reference = Medicare, OR 0.52, P = .001), and unambiguous extraprostatic extension on mpMRI (OR 2.94, P = .01) were independently associated with csPCa. PI-RADS 3 assessment (OR 1.18, P = .56), age (OR 0.99, P = .39), and African American race (OR 0.90, P = .75) were not.DiscussionAlthough there is known in-practice variation in radiologists' interpretation of mpMRI, in our multidisciplinary prostate cancer program we found no significant radiologist-attributable variation in csPCa detection.

Dataset Information

Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category.

Background

Objective

Design setting and participants

Outcome measurement and statistical analysis

Results and limitations

Conclusions

Patient summary

Publications

Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category.

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