Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissectio
Fluorine-18 (18F) prostate-specific membrane antigen (PSMA) 1007 (18F-PSMA-1007) is a radiotracer used in prostate cancer (PCa) staging. So far, no large histopathological validation study has been conducted. The objective was to determine diagnostic accuracy of 18F-PSMA-1007 PET/CT compared to histopathological results of extended pelvic lymph node dissection (ePLND) in men with intermediate- or high-risk PCa.
Men with newly confirmed intermediate- or high-risk PCa were prospectively enrolled in the Molecular Imaging 18F-PSMA-1007 PET/CT for lymph Node sTaging in primary PCa (MINT) trial. PET/CT images were read by two nuclear medicine physicians. Diagnostic accuracy was evaluated by histopathology of template resections. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) for LNI detection of 18F-PSMA-1007 PET/CT were calculated.
Ninety-nine men were evaluated; 30.3% showed histologically confirmed LNI. Median number of resected nodes was 22 (IQR 17-28). Patient-based sensitivity, specificity, PPV, and NPV were 53.3% (95% CI 34.3-71.7%), 89.9% (95% CI 80.2-95.8%), 69.6% (95% CI 51.2-83.3%), and 81.6% (95% CI 75.0-86.8%), respectively. Template-based sensitivity was 12.9% (95% CI 5.7-23.9%), specificity 97.7% (95% CI 96.6-98.5%), PPV 23.5% (95% CI 12.7-39.5%), and NPV 95.3% (95% CI 94.9-95.7%).
18F-PSMA-1007 PET/CT showed high specificity but moderate to low sensitivity for LNI detection in intermediate- and high-risk PCa. It cannot replace ePLND for staging. Additional studies are needed to determine exact scan indications in lymph node staging for the primary diagnostic pathway in intermediate- or high-risk PCa.
December 12, 2018, Netherlands Trial Registry, NTR7670 ( https://www.trialregister.nl/trial/7428 ).
Hermsen R
,Wedick EBC
,Vinken MJM
,van Kalmthout LWM
,Küsters-Vandevelde HVN
,Wijers CHW
,Somford DM
,van Basten JA
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Can Negative Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography Avoid the Need for Pelvic Lymph Node Dissection in Newly Diagnosed Prostate Cancer Patients? A Systematic Review and Meta-analysis with Backup Histology as Re
The role of positron emission tomography/computed tomography (PET/CT) with prostate-specific membrane antigen (PSMA) in the primary staging for patients with prostate cancer (PCa) is still debated.
To analyze published studies reporting the accuracy of PSMA PET/CT for detecting lymph node invasion (LNI) at pelvic lymph node dissection (PLND).
A search of PubMed/MEDLINE, Cochrane library's Central, EMBASE and Scopus databases, from inception to May 2021, was conducted. The primary outcome was to evaluate the sensitivity, specificity, positive (PPV) and negative (NPV) predictive values of PSMA PET/CT in detecting LNI on a per-patient level. As a secondary outcome, NPV of PET PSMA was tested on a per-node-level analysis. Detection rates were pooled using random-effect models. Preplanned subgroup analyses tested the diagnostic accuracy after stratification for the preoperative risk group. PPV and NPV variation over LNI prevalence was evaluated. Only studies including extended PLND (ePLND) as the reference standard test were included.
Twenty-seven studies, with a total of 2832 participants, were included in quantitative synthesis. The sensitivity, specificity, PPV, and NPV of PSMA PET/CT for LNI were, respectively, 58% (95% confidence interval [CI] 50-66%), 95% (95% CI 93-97%), 79% (95% CI 72-85%), and 87% (95% CI 84-89%), with overall moderate heterogeneity between studies. At bivariate analysis, the diagnostic accuracy of PSMA PET/CT estimated through summary receiver operating characteristic-derived area under the curve was 84% (95% CI 81-87%). On a per-node level, NPV of PET PSMA was 97% (95% CI 96-99%). At subgroup analyses, according to preoperative risk groups, sensitivity, specificity, PPV, and NPV were 51%, 93%, 73%, and 81%, respectively, in high-risk patients. Over the LNI prevalence range of 5-40%, PPV increased from 59% to 91%, while NPV decreased from 99% to 84%.
PSMA PET/CT scan provides promising accuracy in the field of primary nodal staging for PCa. The high NPV in men with a lower risk of LNI might be clinically useful to reduce the number of unnecessary PLND procedures performed. Conversely, in high-risk patients, negative PSMA PET/CT cannot replace staging ePLND.
In this systematic review and meta-analysis, we demonstrated that prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) scan may optimize the primary nodal staging and surgical management of prostate cancer patients candidate to radical prostatectomy. The high negative predictive value in men with a lower risk of lymph node invasion might be clinically useful for reducing the number of useless pelvic lymph node dissection (PLND) procedures performed. Conversely, in high-risk patients, negative PSMA PET/CT cannot allow avoiding of PLND.
Stabile A
,Pellegrino A
,Mazzone E
,Cannoletta D
,de Angelis M
,Barletta F
,Scuderi S
,Cucchiara V
,Gandaglia G
,Raggi D
,Necchi A
,Karakiewicz P
,Montorsi F
,Briganti A
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How accurate is (68)Gallium-prostate specific membrane antigen positron emission tomography / computed tomography ((68)Ga-PSMA PET/CT) on primary lymph node staging before radical prostatectomy in intermediate and high risk prostate cancer? A study of pat
Gallium-68 (68Ga)-Prostate Membrane Specific Antigen Positron Emission Tomography/Computed Tomography (68Ga-PSMA PET/CT) is an emerging diagnostic modality which is gaining importance in individualized prostate cancer (PCa) management era. This study aimed to investigate the diagnostic accuracy of 68Ga-PSMA PET/CT on primary LN staging before radical prostatectomy (RP) in intermediate and high risk PCa.
The retrospectively documented 49 patients with intermediate and high risk non-metastatic PCa who had 68Ga-PSMA PET/CT before RP were enrolled into this study. The histopathology of dissected LNs was used as reference standard to evaluate the accuracy of 68Ga-PSMA PET/CT on primary LN staging, both in per-patient (n = 49) and in per-node (n = 454) analyses. The diagnostic accuracy was investigated using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), and by area under the curve (AUC) provided using receiver operating curve (ROC) analysis.
Median age was 64 (48-79) years and, median and mean PSA values were 10 (1.31-138) ng/ml and 16.2 (±19.8) ng/ml, respectively. 22 (44.9%) and 27 (55.1%) of patients had intermediate and high risk PCa, respectively. A total of 5 (10.2%) patients had histopathologically proven LN metastasis and 3 (60%) of them was detected in 68Ga-PSMA PET/CT. In per patient analysis, the sensitivity, specifity, PPV and NPV of 68Ga-PSMA PET/CT on primary LN staging were 0.60, 0.96, 0.60 and 0.96, respectively. Among overall 454 LNs, 16 (3.5 %) of them were reported as metastatic in histopathology and, 13 (2.9%) of these metastatic LNs were detected in 68Ga-PSMA PET/CT. In per-node analysis, the sensitivity, specificity, PPV and NPV of 68Ga-PSMA PET/CT on primary LN staging were 0.82, 0.99, 0.87 and 0.99, respectively. The ROC analyses found AUCs for primary LN staging as 0.777 (95%CI:0.508-1.0) in per patient analysis and, as 0.904 (95%CI:0.790 - 1.0) in per node analysis, respectively.
The use of 68Ga-PSMA PET/CT has promising diagnostic accuracy on primary LN staging before RP in intermediate and high risk PCa. However, the efforts should be taken to increase sensitivity of 68Ga-PSMA PET/CT in individualized treatment era.
Erdem S
,Simsek DH
,Degirmenci E
,Aydin R
,Bagbudar S
,Ozluk Y
,Sanli Y
,Sanli O
,Ozcan F
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