Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov;84(5):491-502.
doi: 10.1016/j.eururo.2023.06.008. Epub 2023 Jul 4.

Prostate-specific Membrane Antigen Reporting and Data System Version 2.0

Affiliations

Prostate-specific Membrane Antigen Reporting and Data System Version 2.0

Rudolf A Werner et al. Eur Urol. 2023 Nov.

Abstract

Prostate-specific Membrane Antigen Reporting and Data System (PSMA-RADS) was introduced for standardized reporting, and PSMA-RADS version 1.0 allows classification of lesions based on their likelihood of representing a site of prostate cancer on PSMA-targeted positron emission tomography (PET). In recent years, this system has extensively been investigated. Increasing evidence has accumulated that the different categories reflect their actual meanings, such as true positivity in PSMA-RADS 4 and 5 lesions. Interobserver agreement studies demonstrated high concordance among a broad spectrum of 68Ga- or 18F-labeled, PSMA-directed radiotracers, even for less experienced readers. Moreover, this system has also been applied to challenging clinical scenarios and to assist in clinical decision-making, for example, to avoid overtreatment in oligometastatic disease. Nonetheless, with an increasing use of PSMA-RADS 1.0, this framework has shown not only benefits, but also limitations, for example, for follow-up assessment of locally treated lesions. Thus, we aimed to update the PSMA-RADS framework to include a refined set of categories in order to optimize lesion-level characterization and best assist in clinical decision-making (PSMA-RADS version 2.0).

Keywords: Prostate carcinoma; Prostate-specific membrane antigen; Reporting and data system; Structured reporting.

PubMed Disclaimer

Conflict of interest statement

Financial disclosures: Steven P. Rowe certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Under a license agreement between Progenics (a wholly owned subsidiary of Lantheus) and the Johns Hopkins University, Martin G. Pomper and the University are entitled to royalties on an invention described in this article. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies. Steven P. Rowe is a consultant and Michael A. Gorin has been a consultant for Progenics Pharmaceuticals, Inc. Rudolf A. Werner has received speaker honoraria from Novartis, Bayer, PentixaPharm, and Boston Scientific (outside of the submitted work). Matthias Eiber reports fees from Blue Earth Diagnostics Ltd. (consultant, research funding), Novartis/AAA (consultant and speaker), Telix (consultant), Bayer (consultant and research funding), RayzeBio (consultant), Point Biopharma (consultant), Eckert-Ziegler (speaker), Janssen Pharmaceuticals (consultant and speakers’ bureau), Parexel (image review), and Bioclinica (image review) outside the submitted work, and a patent application for rhPSMA. Thomas A. Hope reports grant funding to the institution from Clovis Oncology, Philips, GE Healthcare, Lantheus, the Prostate Cancer Foundation, and the National Cancer Institute (R01CA235741 and R01CA212148). He received personal fees from Ipsen, Bayer, and BlueEarth Diagnostics, and received fees from and has an equity interest in RayzeBio and Curium. Wolfgang P. Fendler reports fees from SOFIE Bioscience (research funding), Janssen (consultant and speaker), Calyx (consultant and image review), Bayer (consultant, speaker, and research funding), Novartis (speaker), and Telix (speaker), outside of the submitted work. All other authors declare that there is no conflict of interest as well as consent for scientific analysis and publication.

Figures

Fig. 1 –
Fig. 1 –
PSMA-RADS 1: whole-body maximum-intensity-projection image of a patient with biochemically recurrent PC imaged with 18F-PSMA-1007. No sites of abnormal uptake can be appreciated. Normal biodistribution of this agent is displayed, including intensive uptake in lacrimal glands, liver, spleen, and kidneys, and low uptake in the small bowel, along with almost no urinary tract excretion of the radiotracer. PC = prostate cancer; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 2 –
Fig. 2 –
PSMA-RADS 1: two patients with biochemically recurrent PC. (A-C) Intense uptake on transaxial 18F-PSMA-1007 PSMA-PET/CT in a paravertebral structure (arrows), which might be misinterpreted as a lymph node. Instead, this is a typical finding of a cervicothoracic, PSMA-avid ganglion. (D–F) Diffuse uptake pattern in peripheral fibrous changes and ground glass opacities in both lungs (arrows). This patient has shortly recovered from a COVID-19 infection and demonstrated unspecific 18F-PSmA-1007 uptake in the lower lung. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 3 –
Fig. 3 –
PSMA-RADS 2: two patients with biochemically recurrent PC and likely benign findings. The first patient had pronounced degenerative changes in the thoracic spine with spondylophyte formation. (A) Sagittal CT, (B) sagittal 18F-PSMA-1007 PET, and (C) fused images revealed intense uptake in a ventral spondylophyte (arrows), most likely caused by degenerative changes. (E) Axial 18F-PSMA-1007 PET (and (F) axial fused images show mild uptake in a nonenlarged axillary lymph node on (D) axial CT (arrows). Such findings in the axilla (or in hilar or mediastinal lymph nodes) are often unspecific or indicate chronic inflammatory process. Especially if distributed symmetrically, these are not suggestive of PC in the context of biochemical recurrence. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 4 –
Fig. 4 –
PSMA-RADS 3A: two patients with rising PSA levels and equivocal uptake in parailiacal lymph nodes. (A and D) Axial CT, (B and E) axial 18F-PSMA-1007 PET, and (C and F) axial fused images revealed small (short-axis diameter, <0.8 cm) left parailiacal lymph nodes (arrows). The degree of uptake is only slightly above the background, leaving this finding indeterminate. In general, biopsy of these lymph nodes may be considered. Otherwise, follow-up imaging in 3–6 mo may be recommended. PET = positron emission tomography; PSA = prostate-specific antigen; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 5 –
Fig. 5 –
PSMA-RADS 3B: two patients with recurrent PC and equivocal uptake in bone lesions. (B) Axial 18F-PSMA-1007 PET and (C) axial fused images showed low focal uptake in a rib without a corresponding lesion in the (A) axial bone window on cT (arrows). (E) Axial 18F-PSMA-1007 PET and (F) axial fused images with low focal uptake in the left iliac bone without an anatomical correlate in the (D) axial bone window on CT (arrows). Given the high frequency of nonspecific bone uptake with 18F-PSMA-1007 [38] such lesions can be difficult to categorize and, depending on the clinical context, a score of PSMA-RADS 2 may be appropriate, at times. These focal low-level uptake sites lacking anatomic correlates render these findings indeterminate for early metastatic disease versus benign processes such as traumatic changes or small sites of fibrous dysplasia. Biopsy is often difficult; follow-up imaging may be considered. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 6 –
Fig. 6 –
PSMA-RADS 3C: intense focal uptake in a soft tissue lesion of a patient with biochemically recurrent PC. (A) Axial CT, (B) axial 18F-PSMA-1007 PET, and (C) axial fused images show exceptionally high uptake in a soft tissue lesion with decent enrichment of contrast agent in the lower spine muscles on the right. Patient’s low PSA level was discordant with this finding. Biopsy of lesion revealed a metastasis of clear cell renal carcinoma that had surgically been removed 13 yr earlier. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSA = prostate-specific antigen; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 7 –
Fig. 7 –
PSMA-RADS 3D: two patients with biochemically recurrent PC and non–radiotracer-avid abnormalities in CT. (A) Axial lung window CT, (B) axial 18F-PSMA-1007 PET, and (C) axial fused images showed a 1 cm right upper lobe nodule without significant uptake (arrows). Despite equivocal findings on additional 18F-FDG PET/CT (not shown), the nodule was surgically removed. Histology revealed an atypical carcinoid of the lung. (D) Axial CT, (E) axial 18F-PSMA-1007 PET, and (F) axial fused images show a 2 cm lymph node adjacent to the left thyroid and the blood vessels (Virchow’s lymph node) and without significant uptake (arrows). The lymph node was surgically removed and histology revealed an infection with mycobacteria other than tuberculosis. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 8 –
Fig. 8 –
PSMA-RADS 4: two patients with biochemically recurrent PC and focal intense uptake without definitive findings on conventional imaging. (A) Axial CT, (B) axial 18F-PSMA-1007 PET, and (C) axial fused images showed high focal uptake consistent with metastatic PC (arrows). However, because the short-axis diameter of lymph node was 0.3 cm (ie, <1.0 cm), this findings would have been considered benign on CT alone. (E) Axial 18F-PSMA-1007 PET (F) and axial fused images showed an intensive focal uptake consistent with metastatic PC (arrows), but no anatomic correlates in corresponding (D) axial bone window CT. Considering the typical location of osseous lesion in the spine, this finding is most likely attributable to PC. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data Sytem.
Fig. 9 –
Fig. 9 –
PSMA-RADS 5: two patients with biochemically recurrent PC and focal intensive uptake with corresponding findings on conventional imaging. (A) Axial CT, (B) axial 18F-PSMA-1007 PET, and (C) axial fused images showed intensive focal uptake in an enlarged right iliac lymph node consistent with metastatic PC (arrows). (E) Axial 18F-PSMA-1007 PET and (F) axial fused images showed an intensive focal uptake in two ribs and sclerotic changes in corresponding (D) axial bone window CT (arrows). These findings are consistent with metastatic PC. CT = computed tomography; PC = prostate cancer; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.
Fig. 10 –
Fig. 10 –
PSMA-RADS 5T: (A) sagittal bone window CT, (B) sagittal 18F-PSMA-1007 PET, and (C) sagittal fused images revealed multiple metastatic disease in the spine with sclerotic changes. One lesion in the upper spine showed additional intense uptake. The other sclerotic lesions in the middle spine had only very low uptake (arrows), which is due to previous external beam radiation therapy from Th9-L2. CT = computed tomography; PET = positron emission tomography; PSMA-RADS = Prostate-specific Membrane Antigen Reporting and Data System.

References

    1. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med 2021;385:1091–103. - PMC - PubMed
    1. Sheikhbahaei S, Werner RA, Solnes LB, et al. Prostate-specific membrane antigen (PSMA)-targeted PET imaging of prostate cancer: an update on important pitfalls. Semin Nucl Med 2019;49:255–70. - PubMed
    1. Sheikhbahaei S, Afshar-Oromieh A, Eiber M, et al. Pearls and pitfalls in clinical interpretation of prostate-specific membrane antigen (PSMA)-targeted PET imaging. Eur J Nucl Med Mol Imaging 2017;44:2117–36. - PubMed
    1. Eiber M, Herrmann K, Calais J, et al. Prostate cancer molecular imaging standardized evaluation (PROMISE): proposed miTNM classification for the interpretation of PSMA-ligand PET/CT. J Nucl Med 2018;59:469–78. - PubMed
    1. Seifert R, Emmett L, Rowe SP, et al. Second version of the prostate cancer molecular imaging standardized evaluation framework including response evaluation for clinical trials (PROMISE V2). Eur Urol 2023;83:405–12. - PubMed

Publication types

Substances