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

Robert Seifert; Louise Emmett; Steven P Rowe; Ken Herrmann; Boris Hadaschik; Jeremie Calais; Frederik L Giesel; Robert Reiter; Tobias Maurer; Matthias Heck; Andrei Gafita; Michael J Morris; Stefano Fanti; Wolfgang A Weber; Thomas A Hope; Michael S Hofman; Wolfgang Peter Fendler; Matthias Eiber

doi:10.1016/j.eururo.2023.02.002

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

Eur Urol. 2023 May;83(5):405-412. doi: 10.1016/j.eururo.2023.02.002. Epub 2023 Mar 17.

Authors

Robert Seifert¹, Louise Emmett², Steven P Rowe³, Ken Herrmann⁴, Boris Hadaschik⁵, Jeremie Calais⁶, Frederik L Giesel⁷, Robert Reiter⁸, Tobias Maurer⁹, Matthias Heck¹⁰, Andrei Gafita⁶, Michael J Morris¹¹, Stefano Fanti¹², Wolfgang A Weber¹³, Thomas A Hope¹⁴, Michael S Hofman¹⁵, Wolfgang Peter Fendler¹⁶, Matthias Eiber¹⁷

Affiliations

¹ Department of Nuclear Medicine, University Hospital Essen, Essen, Germany. Electronic address: [email protected].
² Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia.
³ The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins, University School of Medicine, Baltimore, MD, USA; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
⁴ Department of Nuclear Medicine, University Hospital Essen, Essen, Germany; Ahmanson Translational Theranostics, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, University of California Los Angeles, CA, USA.
⁵ Department of Urology, University Hospital Essen, Essen, Germany.
⁶ Ahmanson Translational Theranostics, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, University of California Los Angeles, CA, USA.
⁷ Department of Nuclear Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.
⁸ Department of Urology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
⁹ Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
¹⁰ Department of Urology, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany; Bavarian Cancer Research Center (BZKF), Erlangen, Germany.
¹¹ Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
¹² IRCCS AOU di Bologna, Bologna, Italy.
¹³ Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁴ Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA, USA.
¹⁵ Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), Peter MacCallum Cancer Centre, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
¹⁶ Department of Nuclear Medicine, University Hospital Essen, Essen, Germany; PET Committee of the German Society of Nuclear Medicine, Göttingen, Germany.
¹⁷ Bavarian Cancer Research Center (BZKF), Erlangen, Germany; Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany.

PMID: 36935345
DOI: 10.1016/j.eururo.2023.02.002

Abstract

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.

Keywords: PSMA-RADS; Prostate cancer; Prostate cancer molecular imaging standardized evaluation; Prostate-specific membrane antigen targeting positron emission tomography.

Publication types

Review

MeSH terms

Gallium Radioisotopes
Humans
Male
Molecular Imaging
Positron Emission Tomography Computed Tomography / methods
Positron-Emission Tomography
Prospective Studies
Prostatic Neoplasms* / diagnostic imaging
Prostatic Neoplasms* / metabolism
Prostatic Neoplasms* / therapy

Substances

Gallium Radioisotopes