Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups

2022 ◽  
Author(s):  
Heiko Schöder ◽  
Thomas A. Hope ◽  
Michael Knopp ◽  
William K. Kelly ◽  
Jeff M. Michalski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Working Group ◽  
Steering Committee ◽  
Emission Tomography ◽  
Prostate Specific Membrane Antigen ◽  
Consensus Document ◽  
Positron Emission ◽  
Clinical Scenarios ◽  
Psma Pet ◽  
Specific Membrane

PURPOSE As prostate-specific membrane antigen (PSMA) positron emission tomography (PET) becomes increasingly available in the United States, the greater sensitivity of the technology in comparison to conventional imaging poses challenges for clinical trials. The NCI Clinical Imaging Steering Committee (CISC) PSMA PET Working Group was convened to coordinate the identification of these challenges in various clinical scenarios and to develop consensus recommendations on how best to integrate PSMA PET into ongoing and upcoming National Clinical Trials Network (NCTN) trials. METHODS NCI CISC and NCI Genitourinary Steering Committee members and leadership nominated clinicians, biostatisticians, patient advocates, and other imaging experts for inclusion in the PSMA PET Working Group. From April to July 2021, the working group met independently and in conjunction with the CISC to frame challenges, including stage migration, response assessment, trial logistics, and statistical challenges, and to discuss proposed solutions. An anonymous, open-ended survey was distributed to members to collect feedback on challenges faced. Representatives from each NCTN group were invited to present an overview of affected trials. From these discussions, the consensus document was developed and circulated for the inclusion of multiple rounds of feedback from both the Working Group and CISC. RESULTS The current consensus document outlines the key challenges for clinical prostate cancer trials resulting from the increasing availability of PSMA PET. We discuss implications for patient selection and definition of end points and provide guidance and potential solutions for different clinical scenarios, particularly with regard to best practices in defining eligibility criteria and outcome measures. RECOMMENDATIONS This article provides guidance regarding clinical trial design and conduct, and the interpretation of trial results.

scholarly journals Prostate-specific membrane antigen positron emission tomography compared to multiparametric MRI for prostate cancer diagnosis: a protocol for a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052277
Author(s):  
Yi Zhao ◽  
Naomi Morka ◽  
Benjamin Scott S Simpson ◽  
Alex Freeman ◽  
Alex Kirkham ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Systematic Review ◽  
Positron Emission Tomography ◽  
Meta Analysis ◽  
Multiparametric Mri ◽  
Emission Tomography ◽  
Prostate Specific Membrane Antigen ◽  
Positron Emission ◽  
Psma Pet ◽  
Specific Membrane

IntroductionThe introduction of multiparametric MRI (mpMRI) has improved almost every aspect of the prostate cancer diagnostic pathway. However, the novel imaging technique, prostate-specific membrane antigen positron emission tomography (PSMA PET) may have demonstrable accuracy in detecting and staging prostate cancer. Here, we describe a protocol for a systematic review and meta-analysis comparing mpMRI to PSMA PET for the diagnosis of suspected prostate cancer.Methods and analysisA systematic search of MEDLINE, EMBASE, PubMed and Cochrane databases will be conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed for screening, data extraction, statistical analysis and reporting. Included papers will be full-text articles providing original data, written in English articles and comparing the use of PSMA PET with mpMRI in the diagnosis of prostate cancer. All studies published between July 1977 and March 2021 will be eligible for inclusion. Study bias and quality will be assessed using Quadas-2 score. To ensure the quality of the reporting of studies, this protocol is written following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 checklist.Ethics and disseminationEthical approval will not be required for this systematic review. Findings will be disseminated through peer-reviewed publications and presentations at both national and international conferences.PROSPERO registration numberCRD42021239296.

scholarly journals Prostate-specific membrane antigen positron emission tomography (PSMA-PET) for local staging of Prostate Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Sungmin Woo ◽  
Soleen Ghafoor ◽  
Anton S. Becker ◽  
Sangwon Han ◽  
Andreas Wibmer ◽  
...  
Keyword(s):  
Threshold Effect ◽  
Emission Tomography ◽  
Prostate Specific Membrane Antigen ◽  
Regression Analyses ◽  
Local Tumor ◽  
Positron Emission ◽  
Psma Pet ◽  
Pet Ct ◽  
Meta Regression ◽  
Specific Membrane

Abstract Purpose: Prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown promise for detecting nodal and distant prostate cancer (PCa) metastases. However, its performance for local tumor staging is not as well established. The purpose of this study was to review the diagnostic performance of PSMA-PET for determining seminal vesical invasion (SVI) and extraprostatic extension (EPE).Methods: Pubmed and Embase databases were searched until January 12, 2020. Studies assessing accuracy of PSMA-PET in determining SVI and EPE were included. Study quality was evaluated with the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. Pooled sensitivity and specificity were calculated using hierarchical summary receiver operating characteristics modeling. Heterogeneity was explored using meta-regression analyses for anatomical imaging component (MRI vs CT) and by testing for a threshold effect.Results: 12 studies (615 patients) were included. Pooled sensitivity and specificity were 0.68 (95%CI 0.53-0.81) and 0.94 (95% CI 0.90-0.96) for SVI and 0.72 (95% CI 0.56-0.84) and 0.87 (95%CI 0.72-0.94) for EPE. Meta-regression analyses showed that for SVI, PET/MRI demonstrated greater sensitivity than PET/CT (0.87 [95%CI 0.75-0.98] vs 0.60 [95% CI 0.47-0.74]; p = 0.02 for joint model) while specificity was comparable (0.91 [95%CI 0.84-0.97] vs. 0.96 [95%CI 0.93-0.99]) but not for EPE (p = 0.08). A threshold effect was present for studies assessing EPE (correlation coefficient = 0.563 [95% CI, -0.234-0.908] between sensitivity and false-positive rate).Conclusion: PSMA-PET has moderate sensitivity and excellent specificity for assessing local tumor extent in patients with PCa. PET/MRI showed potential for greater sensitivity than PET/CT in assessing SVI.[S1] [S1]R1-1

scholarly journals Canadian Urological Association best practice report: Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and PET/magnetic resonance (MR) in prostate cancer

2021 ◽  
Vol 15 (6) ◽  
Author(s):  
Bobby Shaygan ◽  
Katherine Zukotynski ◽  
François Bénard ◽  
Cynthia Ménard ◽  
Golmehr Sistani ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Positron Emission Tomography ◽  
Best Practice ◽  
Emission Tomography ◽  
Primary Therapy ◽  
Prostate Specific Membrane Antigen ◽  
Positron Emission ◽  
Psma Pet ◽  
Disease Staging ◽  
Specific Membrane

Prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) is increasingly being used worldwide as part of the clinical workup for men with prostate cancer. With high overall accuracy for the detection of prostate cancer, PSMA-targeted PET has an increasingly established role in the setting of biochemical failure after primary therapy and an evolving role in the setting of initial disease staging; its utility for guiding management in the setting of metastatic disease is less clear. Although the specificity is high, familiarization with potential pitfalls in the interpretation of PSMA-targeted PET, including knowledge of the causes for false positive and negative examinations, is critical. The aim of this article is to provide an illustrative discussion of the current and evolving clinical indications for PSMA-targeted PET, as well as a review of physiologic radiopharmaceutical biodistribution and potential imaging pitfalls.

scholarly journals Prostate-specific membrane antigen positron emission tomography (PSMA-PET) for local staging of prostate cancer: a systematic review and meta-analysis

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Sungmin Woo ◽  
Soleen Ghafoor ◽  
Anton S. Becker ◽  
Sangwon Han ◽  
Andreas G. Wibmer ◽  
...  
Keyword(s):  
Threshold Effect ◽  
Emission Tomography ◽  
Prostate Specific Membrane Antigen ◽  
Regression Analyses ◽  
Local Tumor ◽  
Positron Emission ◽  
Psma Pet ◽  
Pet Ct ◽  
Meta Regression ◽  
Specific Membrane

Abstract Purpose Prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown promise for detecting nodal and distant prostate cancer (PCa) metastases. However, its performance for local tumor staging is not as well established. The purpose of this study was to review the diagnostic performance of PSMA-PET for determining seminal vesical invasion (SVI) and extraprostatic extension (EPE). Methods Pubmed and Embase databases were searched until January 12, 2020. Studies assessing accuracy of PSMA-PET in determining SVI and EPE were included. Study quality was evaluated with the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. Pooled sensitivity and specificity were calculated using hierarchical summary receiver operating characteristics modeling. Heterogeneity was explored using meta-regression analyses for anatomical imaging component (MRI vs CT) and by testing for a threshold effect. Results Twelve studies (615 patients) were included. Pooled sensitivity and specificity were 0.68 (95% CI 0.53-0.81) and 0.94 (95% CI 0.90-0.96) for SVI and 0.72 (95% CI 0.56-0.84) and 0.87 (95% CI 0.72-0.94) for EPE. Meta-regression analyses showed that for SVI, PET/MRI demonstrated greater sensitivity than PET/CT (0.87 [95% CI 0.75-0.98] vs 0.60 [95% CI 0.47-0.74]; p = 0.02 for joint model) while specificity was comparable (0.91 [95% CI 0.84-0.97] vs. 0.96 [95% CI 0.93-0.99]) but not for EPE (p = 0.08). A threshold effect was present for studies assessing EPE (correlation coefficient = 0.563 [95% CI, −0.234-0.908] between sensitivity and false-positive rate). Conclusion PSMA-PET has moderate sensitivity and excellent specificity for assessing local tumor extent in patients with PCa. PET/MRI showed potential for greater sensitivity than PET/CT in assessing SVI.

scholarly journals Prostate-specific membrane antigen positron emission tomography (PSMA-PET) for local staging of Prostate Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Sungmin Woo ◽  
Soleen Ghafoor ◽  
Anton S. Becker ◽  
Sangwon Han ◽  
Andreas Wibmer ◽  
...  
Keyword(s):  
Threshold Effect ◽  
Emission Tomography ◽  
Prostate Specific Membrane Antigen ◽  
Regression Analyses ◽  
Local Tumor ◽  
Positron Emission ◽  
Psma Pet ◽  
Pet Ct ◽  
Meta Regression ◽  
Specific Membrane

Abstract Purpose: Prostate-specific membrane antigen positron emission tomography (PSMA-PET) has shown promise for detecting nodal and distant prostate cancer (PCa) metastases. However, its performance for local tumor staging is not as well established. The purpose of this study was to review the diagnostic performance of PSMA-PET for determining seminal vesical invasion (SVI) and extraprostatic extension (EPE).Methods: Pubmed and Embase databases were searched until January 12, 2020. Studies assessing accuracy of PSMA-PET in determining SVI and EPE were included. Study quality was evaluated with the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. Pooled sensitivity and specificity were calculated using hierarchical summary receiver operating characteristics modeling. Heterogeneity was explored using meta-regression analyses for anatomical imaging component (MRI vs CT) and by testing for a threshold effect.Results: 12 studies (615 patients) were included. Pooled sensitivity and specificity were 0.68 (95%CI 0.53-0.81) and 0.94 (95% CI 0.90-0.96) for SVI and 0.72 (95% CI 0.56-0.84) and 0.87 (95%CI 0.72-0.94) for EPE. Meta-regression analyses showed that for SVI, PET/MRI demonstrated greater sensitivity than PET/CT (0.87 [95%CI 0.75-0.98] vs 0.60 [95% CI 0.47-0.74]; p = 0.02 for joint model) while specificity was comparable (0.91 [95%CI 0.84-0.97] vs. 0.96 [95%CI 0.93-0.99]) but not for EPE (p = 0.08). A threshold effect was present for studies assessing EPE (correlation coefficient = 0.563 [95% CI, -0.234-0.908] between sensitivity and false-positive rate).Conclusion: PSMA-PET has moderate sensitivity and excellent specificity for assessing local tumor extent in patients with PCa. PET/MRI shows significantly greater sensitivity than PET/CT for assessing SVI.

scholarly journals Current status of radioligand therapy and positron-emission tomography with prostate-specific membrane antigen

2020 ◽  
Vol 34 (12) ◽  
pp. 879-883
Author(s):  
Masayuki Inubushi ◽  
Hiroyuki Miura ◽  
Ichiei Kuji ◽  
Kimiteru Ito ◽  
Ryogo Minamimoto
Keyword(s):  
Prostate Cancer ◽  
Positron Emission Tomography ◽  
The United States ◽  
Emission Tomography ◽  
Current Status ◽  
Prostate Specific Membrane Antigen ◽  
Radioligand Therapy ◽  
Positron Emission ◽  
Psma Pet ◽  
Specific Membrane

AbstractProstate-specific membrane antigen (PSMA) is a transmembrane glycoprotein highly expressed by prostate cancer cells. PSMA-based radioligand therapy (RLT) emerged as a promising therapeutic option for prostate cancer in the early 2000s, and has been clinically validated with great enthusiasm during these past two decades. Last year, the European Association of Nuclear Medicine (EANM) published the procedure guidelines for the safe clinical practice of Lutetium-177 (177Lu)-labelled PSMA RLT. In addition, PSMA RLT with alpha-ray-emitting radioisotopes has been also developed recently. Following the clinical use of 177Lu-PSMA RLT, PSMA-targeted positron-emission tomography (PET) with Gallium-68 (68Ga) has been performed inevitably for “theranostics” for the last decade; prostate cancer is going to be treated with PSMA-RLT based on the diagnosis by PSMA-PET. Furthermore, the diagnostic usefulness of 68Ga-PSMA PET has been documented in various diseases beyond prostate cancer more recently. Regrettably, Japan is behind European countries and the United States in this field, and has just made a belated start of their clinical trials. In this review article, we briefly overviewed the current status of PSMA RLT and PSMA PET. We hope that this topic will be a particular focus of attention for most ANM readers in Japan, and that our efforts will help to facilitate the early approval of PSMA RLT and PSMA PET by the Japanese government even if only slightly.

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