Second Version of the Prostate Cancer Molecular Imaging Standardized Evaluation Framework Including Response Evaluation for Clinical Trials (PROMISE V2)

TY - JOUR

T1 - Second Version of the Prostate Cancer Molecular Imaging Standardized Evaluation Framework Including Response Evaluation for Clinical Trials (PROMISE V2)

AU - Seifert, Robert

AU - Emmett, Louise

AU - Rowe, Steven P

AU - Herrmann, Ken

AU - Hadaschik, Boris

AU - Calais, Jeremie

AU - Giesel, Frederik L

AU - Reiter, Robert

AU - Maurer, Tobias

AU - Heck, Matthias

AU - Gafita, Andrei

AU - Morris, Michael J

AU - Fanti, Stefano

AU - Weber, Wolfgang A

AU - Hope, Thomas A

AU - Hofman, Michael S

AU - Fendler, Wolfgang Peter

AU - Eiber, Matthias

N1 - Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.

PY - 2023/5

Y1 - 2023/5

N2 - CONTEXT: Prostate-specific membrane antigen (PSMA) targeting positron emission tomography (PET) is emerging to become a reference imaging tool for the staging and restaging of patients with prostate cancer for both clinical routine and trials. The prostate cancer molecular imaging standardized evaluation (PROMISE) criteria have been proposed as a framework for whole-body staging (molecular imaging TNM staging, denoted miTNM staging) to describe the prostate cancer disease extent on PSMA-PET.OBJECTIVE: To create a comprehensive and integrated framework for PSMA-PET image interpretation and reporting.EVIDENCE ACQUISITION: We propose the PROMISE V2 framework, which integrates an updated miTNM system, improved assessment of local disease, and a slightly modified PSMA-expression score for clinical routine. We have added a response monitoring framework defining qualitative and quantitative parameters to be recorded for a longitudinal assessment in clinical trials.EVIDENCE SYNTHESIS: We provide a comprehensive literature review on the current use of the PROMISE framework in clinical research and prospective trials. PROMISE variables demonstrate a clear association with survival. PSMA expression assessed by the PSMA-expression score was used in several trials, and a low PSMA-expression score is a negative prognosticator of overall survival after 177Lu-PSMA radioligand therapy. The proposed imaging parameters recorded for response assessment in clinical trials can be utilized to determine response according to PSMA-PET progression (PPP) or Response Evaluation Criteria in PSMA-PET/Computed Tomography (RECIP) frameworks, but also future response criteria.CONCLUSIONS: PROMISE V2 offers standardized reporting of disease extent for clinical routine and research. Parameters recorded within clinical trials facilitate objective response assessment.PATIENT SUMMARY: Prostate-specific membrane antigen (PSMA) targeting positron emission tomography (PET) has become a standard imaging examination for prostate cancer. We propose a comprehensive framework for the analysis and reporting of PSMA-PET findings that will improve the communication between imaging experts and uro-oncologists.

AB - CONTEXT: Prostate-specific membrane antigen (PSMA) targeting positron emission tomography (PET) is emerging to become a reference imaging tool for the staging and restaging of patients with prostate cancer for both clinical routine and trials. The prostate cancer molecular imaging standardized evaluation (PROMISE) criteria have been proposed as a framework for whole-body staging (molecular imaging TNM staging, denoted miTNM staging) to describe the prostate cancer disease extent on PSMA-PET.OBJECTIVE: To create a comprehensive and integrated framework for PSMA-PET image interpretation and reporting.EVIDENCE ACQUISITION: We propose the PROMISE V2 framework, which integrates an updated miTNM system, improved assessment of local disease, and a slightly modified PSMA-expression score for clinical routine. We have added a response monitoring framework defining qualitative and quantitative parameters to be recorded for a longitudinal assessment in clinical trials.EVIDENCE SYNTHESIS: We provide a comprehensive literature review on the current use of the PROMISE framework in clinical research and prospective trials. PROMISE variables demonstrate a clear association with survival. PSMA expression assessed by the PSMA-expression score was used in several trials, and a low PSMA-expression score is a negative prognosticator of overall survival after 177Lu-PSMA radioligand therapy. The proposed imaging parameters recorded for response assessment in clinical trials can be utilized to determine response according to PSMA-PET progression (PPP) or Response Evaluation Criteria in PSMA-PET/Computed Tomography (RECIP) frameworks, but also future response criteria.CONCLUSIONS: PROMISE V2 offers standardized reporting of disease extent for clinical routine and research. Parameters recorded within clinical trials facilitate objective response assessment.PATIENT SUMMARY: Prostate-specific membrane antigen (PSMA) targeting positron emission tomography (PET) has become a standard imaging examination for prostate cancer. We propose a comprehensive framework for the analysis and reporting of PSMA-PET findings that will improve the communication between imaging experts and uro-oncologists.

KW - Male

KW - Humans

KW - Prospective Studies

KW - Prostatic Neoplasms/diagnostic imaging

KW - Positron Emission Tomography Computed Tomography/methods

KW - Positron-Emission Tomography

KW - Molecular Imaging

KW - Gallium Radioisotopes

U2 - 10.1016/j.eururo.2023.02.002

DO - 10.1016/j.eururo.2023.02.002

M3 - SCORING: Review article

C2 - 36935345

VL - 83

SP - 405

EP - 412

JO - EUR UROL

JF - EUR UROL

SN - 0302-2838

IS - 5

ER -