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Combination of ⁶⁸Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis.

ABSTRACT: Our purpose was to explore whether ⁶⁸Ga-PSMA PET/CT alone (PET/CT) or in combination with multiparametric MRI (PET/MRI) can improve the detection of clinically significant prostate cancer (PCa). Methods: We retrospectively enrolled 54 patients who underwent both MRI and PET/CT before radical prostatectomy. Regions of interest on MR images, PET/CT images, and pathologic images were marked. A lesion was defined as a region of interest marked on images obtained with any of the 3 modalities. All lesions were characterized using the prostate imaging reporting and data system (PI-RADS), the molecular imaging PSMA expression score, and the pathologic results and analyzed. Diagnostic performance was analyzed by receiver-operating-characteristic analysis. Specific improvement for lesions with different PI-RADS scores was analyzed using the net reclassification index (NRI). Results: In total, 90 lesions from 54 patients were analyzed, among which 66 lesions represented clinically significant PCa. Receiver-operating-characteristic analysis showed PET/MRI to perform better than MRI in detecting clinically significant PCa (change in area under the curve, 0.06; 95% confidence interval, 0.01-0.12; P < 0.05). With the calculated cutoff, PET/MRI performed significantly better than MRI (NRI, 21.9%; P < 0.01), with an improvement in sensitivity (89% vs. 76%, P < 0.01) at no sacrifice of specificity (96% vs. 88%, P > 0.05). Improvement in diagnosing clinically significant PCa occurred for lesions classified as PI-RADS 3 (NRI, 66.7%; P < 0.01). Conclusion: PET/MRI improves the detection of clinically significant PCa for PI-RADS 3 lesions.

SUBMITTER: Chen M

PROVIDER: S-EPMC6604689 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Combination of 68Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis.

Chen Mengxia M Zhang Qing Q Zhang Chengwei C Zhao Xiaozhi X Marra Giancarlo G Gao Jie J Lv Xiaoyu X Zhang Bing B Fu Yao Y Wang Feng F Qiu Xuefeng X Guo Hongqian H

Journal of nuclear medicine : official publication, Society of Nuclear Medicine 20181214 7

Our purpose was to explore whether 68Ga-PSMA PET/CT alone (PET/CT) or in combination with multiparametric MRI (PET/MRI) can improve the detection of clinically significant prostate cancer (PCa). Methods: We retrospectively enrolled 54 patients who underwent both MRI and PET/CT before radical prostatectomy. Regions of interest on MR images, PET/CT images, and pathologic images were marked. A lesion was defined as a region of interest marked on images obtained with any of the 3 m ...[more]

PMID: 30552201

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Project description:The purpose of this study was to investigate the feasibility and diagnostic efficacy of 68Ga-prostate-specific membrane antigen (PSMA) PET/CT combined with PET/ultrasound-guided biopsy in the diagnosis of prostate cancer (PCa). Methods: In total, 31 patients with a previously negative prostate biopsy but persistent elevated serum prostate-specific antigen (PSA) were imaged with a 68Ga-PSMA PET/CT ligand before undergoing repeat prostate biopsy. On the basis of the proposed Prostate Cancer Molecular Imaging Standardized Evaluation criteria, 68Ga-PSMA PET/CT results were interpreted as negative (molecular-imaging-for-PSMA expression score [miPSMA-ES] of 0-1) or positive (miPSMA-ES of 2-3). All patients underwent standard template systematic biopsy with up to 4 additional PET/ultrasound-guided biopsy cores. The sensitivity, specificity, positive and negative predictive values, and accuracy of 68Ga-PSMA PET/CT were determined. In addition, the correlation between the miPSMA-ES and the detection rate of PCa was also analyzed. Univariate logistic regression models were established using 68Ga-PSMA PET/CT semiquantitative analysis parameters to predict the outcome of repeat prostate biopsy. Results: The median age of patients was 65 y (range, 53-81 y), and the median PSA level was 18.0 ng/mL (range, 5.48-49.77 ng/mL). PCa was detected in 15 of 31 patients (48.4%), and 12 of 31 patients (38.7%) had clinically significant PCa (csPCa). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 68Ga-PSMA PET/CT in the diagnosis of csPCa were 100.0%, 68.4%, 66.7%, 100.0%, and 80.6%, respectively. The detection rate of PCa increased with the increase in miPSMA-ES. The detection rates of csPCa in the miPSMA-ES 0-1, 2, and 3 groups were 0%, 54.5%, and 85.7%, respectively. Semiquantitative analysis of 68Ga-PSMA PET/CT images showed that predictive models based on the SUVmax of prostate lesion, tumor-to-normal-prostate background SUVmax, and tumor-to-normal-liver background SUVmax could effectively predict csPCa; area under the curves were 0.930, 0.877, and 0.956, respectively. Conclusion: This study preliminarily confirmed that 68Ga-PSMA PET/CT imaging, combined with PET/ultrasound-guided prostate biopsy, can effectively detect csPCa. Prebiopsy 68Ga-PSMA PET/CT had predictive value for csPCa in the studied patient population.

Project description:BackgroundThe prostate-specific antigen (PSA) has been widely used in screening and early diagnosis of prostate cancer (PCa). However, in the PSA grey zone of 4-10 ng/ml, the sensitivity and specificity for diagnosing PCa are limited, resulting in considerable number of unnecessary and invasive prostate biopsies, which may lead to potential overdiagnosis and overtreatment. We aimed to predict clinically significant PCa (CSPCa) by combining the maximal standardized uptake value (SUVmax) based on 68Ga‑PSMA PET/CT and clinical indicators in men with gray zone PSA levels.Methods81 patients with suspected PCa based on increased serum total PSA (TPSA) levels of 4 - 10 ng/mL who underwent transrectal ultrasound/magnetic resonance imaging (MRI)/PET fusion-guided biopsy were enrolled. Among them, patients confirmed by histopathology were divided into the CSPCa group and the non-CSPCa group, and data on PSA concentration, prostate volume (PV), PSA density (PSAD), free PSA (FPSA)/TPSA, Prostate Imaging-Reporting and Data System version 2.1 (PI-RADS v2.1) score, 68Ga-PSMA PET/CT imaging evaluation results and SUVmax were compared. Multivariate logistic regression analysis was performed to identify the independent predictors for CSPCa, thereby establishing a predictive model based on SUVmax that was evaluated by analyzing the receiver operating characteristic (ROC) curve and decision curve analysis.ResultsCompared to non-CSPCa, CSPCa patients had smaller PVs (median, 31.40 mL), lower FPSA/TPSA (median, 0.12), larger PSADs (median, 0.21 ng/mL2) and higher PI-RADS scores (P < 0.05). The prediction model comprising 68Ga-PSMA PET/CT maximal standardized uptake value, PV and FPSA/TPSA had the highest AUC of 0.927 compared with that of other predictors alone (AUCs of 0.585 for PSA, 0.652 for mpMRI and 0.850 for 68Ga-PSMA PET/CT). The diagnostic sensitivity and specificity of the prediction model were 86.21% and 86.54%, respectively.ConclusionGiven the low diagnostic accuracy of regular PSA tests, a new prediction model based on the 68Ga-PSMA PET/CT SUVmax, PV and FPSA/TPSA was developed and validated, and this model could provide a more satisfactory predictive accuracy for CSPCa. This study provides a noninvasive prediction model with high accuracy for the diagnosis of CSPCa in the PSA gray zone, thus may be better avoiding unnecessary biopsy procedures.

Project description:PurposeTo assess 68Ga-PSMA PET/CT for detection of low- and intermediate-risk prostate cancer (PCa), high-risk PCa in comparison with mpMRI, respectively, and to determine which of low- and intermediate-risk PCa are more likely to be detected by 68Ga-PSMA PET/CT.MethodsWe conducted a retrospective analysis of patients who had undergone a prostate biopsy and/or radical prostatectomy and who were scanned with 68Ga-PSMA PET/CT and mpMRI between June 2019 and March 2021. The mpMRI images were scored with the Prostate Imaging-Reporting and Data System Version 2.1 (PI-RADS) and were classified as either negative (PI-RADS 1-3) or positive (PI-RADS 4-5). Suspicious 68Ga-PSMA PET/CT lesions were reviewed for each relevant patient and classified by double-trained board-certified nuclear medicine physicians. The results were evaluated with the histopathological outcome. All patients were classified according to the D'Amico classification, and the clinical data were combined for stratified analysis.ResultA total of 101 patients who were pathologically diagnosed with PCa were analyzed. Of the 101 patients, 88 (80.6%) patients presented with a pathologic mpMRI, and 85 (79.1%) with a pathologic 68Ga-PSMA PET/CT. In the high-risk PCa cohort, 68Ga-PSMA PET/CT was positive in 64/66 (97.0%) patients and yielded a higher detection rate than that for the mpMRI patients (58/66, 87.9%; p < 0.05). However, mpMRI provided superior diagnostic confidence in identifying low- and intermediate-risk PCa (30/35, 85.7% vs. 21/35, 60.0%; p < 0.05). When the age threshold exceeded 62.5 years and the serum prostate specific antigen (PSA) threshold exceeded 9.4 ng/ml, a higher uptake of PSMA was more likely to occur in the lesions of low- and intermediate-risk PCa.ConclusionThe diagnostic performance of 68Ga-PSMA PET/CT was superior to that of mpMRI in the high-risk PCa cohort, which was consistent with prior studies. Furthermore, in the initial diagnosis of low- and intermediate-risk PCa, we found that mpMRI showed a higher diagnostic accuracy than 68Ga-PSMA PET/CT did. Low- and intermediate-risk PCa patients with a PSA ≥ 9.4 ng/ml and age ≥ 62.5 years were more likely to have a positive 68Ga-PSMA PET/CT result.

Project description:PurposeWe aimed to compare the diagnostic performance and biodistribution of two similar PET agents, [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11, in the same group of primary prostate cancer (PCa) patients.MethodsFifty patients with untreated, histologically confirmed PCa by needle biopsy were enrolled. Each patient underwent [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11 PET/CT within a week. In addition to visual analysis, the standardized uptake value (SUV) was measured for semiquantitative comparison and correlation analysis.Results[68Ga]Ga-P16-093 PET/CT detected more positive tumors than [68Ga]Ga-PSMA-11 PET/CT (202 vs. 190, P = 0.002), both for intraprostatic lesions (48 vs. 41, P = 0.016) and metastatic lesions (154 vs. 149, P = 0.125), especially for intraprostatic lesions in low- and intermediate-risk PCa patients (21/23 vs. 15/23, P = 0.031). Furthermore, [68Ga]Ga-P16-093 PET/CT exhibited a significantly higher SUVmax for most matched tumors (13.7 ± 10.2 vs. 11.4 ± 8.3, P < 0.001). For normal organs, [68Ga]Ga-P16-093 PET/CT showed significantly lower activity in the kidney (SUVmean: 20.1 ± 6.1 vs. 29.3 ± 9.1, P < 0.001) and urinary bladder (SUVmean: 6.5 ± 7.1 vs. 20.9 ± 17.4, P < 0.001), but displayed a higher uptake in the parotid gland (SUVmean: 8.7 ± 2.6 vs. 7.6 ± 2.1, P < 0.001), liver (SUVmean: 7.0 ± 1.9 vs. 3.7 ± 1.3, P < 0.001), and spleen (SUVmean: 8.2 ± 3.0 vs. 5.2 ± 2.2, P < 0.001) than [68Ga]Ga-PSMA-11 PET/CT.Conclusion[68Ga]Ga-P16-093 PET/CT demonstrated higher tumor uptake and better tumor detectability than [68Ga]Ga-PSMA-11 PET/CT, especially in low- and intermediate-risk PCa patients, which indicated that [68Ga]Ga-P16-093 may serve as an alternative agent for detection of PCa.Trial registration68Ga-P16-093 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Primary Prostate Cancer Patients (NCT05324332, Registered 12 April 2022, retrospectively registered). URL OF REGISTRY: https://clinicaltrials.gov/ct2/show/NCT05324332 .

Project description:Prostate-specific membrane antigen (PSMA) is a validated target for molecular diagnostics and targeted radionuclide therapy. Our purpose was to evaluate PSMA expression in hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), and hepatic adenoma (HCA); investigate the genetic pathways in HCC associated with PSMA expression; and evaluate HCC detection rate with 68 Ga-PSMA-11 positron emission tomography (PET). In phase 1, PSMA immunohistochemistry (IHC) on HCC (n = 148), CCA (n = 111), and HCA (n = 78) was scored. In a subset (n = 30), messenger RNA (mRNA) data from the Cancer Genome Atlas HCC RNA sequencing were correlated with PSMA expression. In phase 2, 68 Ga-PSMA-11 PET was prospectively performed in patients with treatment-naïve HCC on a digital PET scanner using cyclotron-produced 68 Ga. Uptake was graded qualitatively and semi-quantitatively using standard metrics. On IHC, PSMA expression was significantly higher in HCC compared with CCA and HCA (P < 0.0001); 91% of HCCs (n = 134) expressed PSMA, which principally localized to tumor-associated neovasculature. Higher tumor grade was associated with PSMA expression (P = 0.012) but there was no association with tumor size (P = 0.14), fibrosis (P = 0.35), cirrhosis (P = 0.74), hepatitis B virus (P = 0.31), or hepatitis C virus (P = 0.15). Overall survival tended to be longer in patients without versus with PSMA expression (median overall survival: 4.2 vs. 1.9 years; P = 0.273). FGF14 (fibroblast growth factor 14) mRNA expression correlated positively (rho = 0.70; P = 1.70 × 10-5 ) and MAD1L1 (Mitotic spindle assembly checkpoint protein MAD1) correlated negatively with PSMA expression (rho = -0.753; P = 1.58 × 10-6 ). Of the 190 patients who met the eligibility criteria, 31 patients with 39 HCC lesions completed PET; 64% (n = 25) lesions had pronounced 68 Ga-PSMA-11 standardized uptake value: SUVmax (median [range] 9.2 [4.9-28.4]), SUVmean 4.7 (2.4-12.7), and tumor-to-liver background ratio 2 (1.1-11). Conclusion: Ex vivo expression of PSMA in neovasculature of HCC translates to marked tumor avidity on 68 Ga-PSMA-11 PET, which suggests that PSMA has the potential as a theranostic target in patients with HCC.

Project description:PurposeRisk classification of primary prostate cancer in clinical routine is mainly based on prostate-specific antigen (PSA) levels, Gleason scores from biopsy samples, and tumor-nodes-metastasis (TNM) staging. This study aimed to investigate the diagnostic performance of positron emission tomography/magnetic resonance imaging (PET/MRI) in vivo models for predicting low-vs-high lesion risk (LH) as well as biochemical recurrence (BCR) and overall patient risk (OPR) with machine learning.MethodsFifty-two patients who underwent multi-parametric dual-tracer [18F]FMC and [68Ga]Ga-PSMA-11 PET/MRI as well as radical prostatectomy between 2014 and 2015 were included as part of a single-center pilot to a randomized prospective trial (NCT02659527). Radiomics in combination with ensemble machine learning was applied including the [68Ga]Ga-PSMA-11 PET, the apparent diffusion coefficient, and the transverse relaxation time-weighted MRI scans of each patient to establish a low-vs-high risk lesion prediction model (MLH). Furthermore, MBCR and MOPR predictive model schemes were built by combining MLH, PSA, and clinical stage values of patients. Performance evaluation of the established models was performed with 1000-fold Monte Carlo (MC) cross-validation. Results were additionally compared to conventional [68Ga]Ga-PSMA-11 standardized uptake value (SUV) analyses.ResultsThe area under the receiver operator characteristic curve (AUC) of the MLH model (0.86) was higher than the AUC of the [68Ga]Ga-PSMA-11 SUVmax analysis (0.80). MC cross-validation revealed 89% and 91% accuracies with 0.90 and 0.94 AUCs for the MBCR and MOPR models respectively, while standard routine analysis based on PSA, biopsy Gleason score, and TNM staging resulted in 69% and 70% accuracies to predict BCR and OPR respectively.ConclusionOur results demonstrate the potential to enhance risk classification in primary prostate cancer patients built on PET/MRI radiomics and machine learning without biopsy sampling.

Dataset Information

Combination of ⁶⁸Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis.

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Combination of <sup>68</sup>Ga-PSMA PET/CT and Multiparametric MRI Improves the Detection of Clinically Significant Prostate Cancer: A Lesion-by-Lesion Analysis.

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