PSMA scan explained

A PSMA scan is a nuclear medicine imaging technique used in the diagnosis and staging of prostate cancer. It is carried out by injection of a radiopharmaceutical with a positron or gamma emitting radionuclide and a prostate-specific membrane antigen (PSMA) targeting ligand. After injection, imaging of positron emitters such as gallium-68 (68Ga), copper-64 (64Cu), and fluorine-18 (18F) is carried out with a positron emission tomography (PET) scanner. For gamma emitters such as technetium-99m (99mTc) and indium-111 (111In) single-photon emission computed tomography (SPECT) imaging is performed with a gamma camera.

As well as the diagnosis and staging of prostate cancer, PSMA imaging can also be used to assess suitability for and plan treatment with external beam radiotherapy and PSMA-targeted radionuclide therapy.[1] [2]

Mechanism

Attempts have been made to target the overexpression of PSMA in prostate cancer cells for several decades, although PSMA is also found in other tissue. PSMA targeting molecules have included antibodies, aptamers, peptides, and small-molecule inhibitors.[3] [4] Initially, development focussed on the antibody capromab. Later research has focussed on small molecule ligands that bind to the extracellular active centre of PSMA, such as PSMA-11.[5] These ligands for PSMA-scanning target the large extracellular region of the PSMA glycoprotein.[6]

PSMA however is also over-expressed in non prostate cancer cells, including kidney, salivary gland, lacrimal gland and duodenal mucosa, where physiological uptake may be seen on imaging.[7]

Clinical use

European Association of Urology (EAU) guidelines recognise that PSMA can provide accurate staging, however there is a lack of outcome data to inform further management.[8] The American Society of Clinical Oncology (ASCO) guidelines for imaging of advanced prostate cancer also recommend PSMA imaging (among other PET radiopharmaceuticals), while acknowledging that these are not FDA approved and therefore limited to a clinical trial or other controlled research setting.[9]

Radiopharmaceuticals

Radionuclide Name Brand name(s) FDA approval EMA approval References
18F DCFPyL PIFLUFOLASTAT F-18 [10] [11]
18F PSMA-1007
18F rhPSMA-7.3 Posluma
68Ga PSMA-11 Gallium (68Ga) gozetotide
68Ga THP-PSMA Gallium (68Ga) gozetotide GalliProst [12]
99mTc PSMA-11
99mTc iPSMA TLX599-CDx [13]
111In capromab pendetide Prostascint [14]
111In PSMA-I&T

Availability

In part thanks to the wide range of similar PSMA radiopharmaceuticals,[15] approval by regulatory authorities is at varying stages. Even so, use has been widespread in some areas, particularly as part of clinical trials. For example, European Association of Urology (EAU) guidelines have included recommendations to perform PSMA PET scans in certain circumstances since 2018, and there has been widespread agreement of the utility of PSMA scanning for several years.[16] [17] [18] [19]

Oceania

Australia

A kit for manufacture of a 68Ga-PSMA-11 product, branded Illucix, was approved by Australia's Therapeutic Goods Administration (TGA) in 2021.[20]

Europe

A marketing authorisation application for 68Ga-PSMA-11 (INN Gallium (68Ga) gozetotide), under the brand name Illucix, was made to the Danish Medicines Agency, on behalf of several EU countries and the UK. Approval is expected in 2022.[21] [22]

In 2022 a marketing authorisation application was made by the manufacturer of 18F-DCFPyL (branded Pylclari) to the European Medicines Agency. [11]

Polish manufacturer and distributor of radiopharmaceutical procuts, Polatom, has been granted a US patent for a 99mTc-PSMA-T4 kit.[23] [24] In the UK, Tc-99m labelled PSMA has product authorisation but lacks funding.[25]

North America

Canada

A new drug submission was made to Canada's regulator in 2021, for 68Ga-PSMA-11.[26]

United States

The first approved PSMA imaging agent was indium-111 (111In) capromab pendetide (branded Prostascint). It received Food and Drug Administration (FDA) approval in 1996. However, the agent had poor sensitivity and saw little widespread use.

The first PET PSMA imaging agent, 68Ga-PSMA-11, was approved by the FDA in 2020.[27] Listed indications include suspected metastasis prior to initial treatment, and recurrence of prostate cancer (based on elevated serum prostate-specific antigen (PSA) level).[28] This was followed by two further 68Ga-PSMA-11 agents in 2021 and 2022 (branded Illucix and Locametz).[29] [30] Listed indications for Lucametz additionally includes selection of patients prior to 177Lu-PSMA radionuclide therapy.[31]

An 18F-PSMA agent (18F-DCFPyL) (branded Pylarify) was approved by the FDA in 2021.[32] Indications are as for 68Ga-PSMA-11.[33] [34]

Another 18F-PSMA agent (18F-rhPSMA-7.3) (branded Posluma) was approved by the FDA in 2023. [35]

South America

Brazil

68Ga-PSMA-11 (Illucixwas) was granted initial authorisation in 2021, with full approval expected in 2022.[36] [37]

Notes and References

  1. Wang . Fujin . Li . Zhifeng . Feng . Xiaoqian . Yang . Dazhuang . Lin . Mei . Advances in PSMA-targeted therapy for prostate cancer . Prostate Cancer and Prostatic Diseases . March 2022 . 25 . 1 . 11–26 . 10.1038/s41391-021-00394-5 . 34050265. 235241529 .
  2. Mena . Esther . Lindenberg . Liza . Choyke . Peter . The Impact of PSMA PET/CT Imaging in Prostate Cancer Radiation Treatment . Seminars in Nuclear Medicine . March 2022 . 52 . 2 . 255–262 . 10.1053/j.semnuclmed.2021.12.008 . 35016755 . 8960055.
  3. Wang . He . He . Zhangxin . Liu . Xiao-Ang . Huang . Yuhua . Hou . Jianquan . Zhang . Weijie . Ding . Dan . Advances in Prostate-Specific Membrane Antigen (PSMA)-Targeted Phototheranostics of Prostate Cancer . Small Structures . August 2022 . 3 . 8 . 2200036 . 10.1002/sstr.202200036. 248702668 .
  4. Piron . Sarah . Verhoeven . Jeroen . Vanhove . Christian . De Vos . Filip . Recent advancements in 18F-labeled PSMA targeting PET radiopharmaceuticals . Nuclear Medicine and Biology . March 2022 . 106-107 . 29–51 . 10.1016/j.nucmedbio.2021.12.005 . 34998217. free. 1854/LU-8732924 . free .
  5. Hofman . Michael S. . Hicks . Rodney J. . Maurer . Tobias . Eiber . Matthias . Prostate-specific Membrane Antigen PET: Clinical Utility in Prostate Cancer, Normal Patterns, Pearls, and Pitfalls . RadioGraphics . January 2018 . 38 . 1 . 200–217 . 10.1148/rg.2018170108 . 29320333. free.
  6. de Galiza Barbosa . Felipe . Queiroz . Marcelo Araujo . Nunes . Rafael Fernandes . Costa . Larissa Bastos . Zaniboni . Elaine Caroline . Marin . José Flavio Gomes . Cerri . Giovanni Guido . Buchpiguel . Carlos Alberto . Nonprostatic diseases on PSMA PET imaging: a spectrum of benign and malignant findings . Cancer Imaging . December 2020 . 20 . 1 . 23 . 10.1186/s40644-020-00300-7 . 32169115 . 7071711. free.
  7. Heidegger . Isabel . Kesch . Claudia . Kretschmer . Alexander . Tsaur . Igor . Ceci . Francesco . Valerio . Massimo . Tilki . Derya . Marra . Giancarlo . Preisser . Felix . Fankhauser . Christian D . Zattoni . Fabio . Chiu . Peter . Puche-Sanz . Ignacio . Olivier . Jonathan . van den Bergh . Roderik C N . Kasivisvanathan . Veeru . Pircher . Andreas . Virgolini . Irene . Gandaglia . Giorgio . Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review . Therapeutic Advances in Medical Oncology . January 2022 . 14 . 175883592210819 . 10.1177/17588359221081922 . 35273651 . 8902011.
  8. Web site: EAU Guidelines on Prostate Cancer . Uroweb . European Association of Urology . 8 December 2022 . en . 2022.
  9. Trabulsi . Edouard J. . Rumble . R. Bryan . Jadvar . Hossein . Hope . Thomas . Pomper . Martin . Turkbey . Baris . Rosenkrantz . Andrew B. . Verma . Sadhna . Margolis . Daniel J. . Froemming . Adam . Oto . Aytekin . Purysko . Andrei . Milowsky . Matthew I. . Schlemmer . Heinz-Peter . Eiber . Matthias . Morris . Michael J. . Choyke . Peter L. . Padhani . Anwar . Oldan . Jorge . Fanti . Stefano . Jain . Suneil . Pinto . Peter A. . Keegan . Kirk A. . Porter . Christopher R. . Coleman . Jonathan A. . Bauman . Glenn S. . Jani . Ashesh B. . Kamradt . Jeffrey M. . Sholes . Westley . Vargas . H. Alberto . Optimum Imaging Strategies for Advanced Prostate Cancer: ASCO Guideline . Journal of Clinical Oncology . 10 June 2020 . 38 . 17 . 1963–1996 . 10.1200/JCO.19.02757 . 32048940. free.
  10. Web site: PSMA Radiopharmaceutical Effective against Prostate Cancer . . . en . 29 June 2021.
  11. Curium Announces The Submission Of Its Marketing Authorization Application For [18F]-DCFPyL To The European Medicines Agency ]. 27 June 2022 . Curium .
  12. Neels . Oliver C . Kopka . Klaus . Liolios . Christos . Afshar-Oromieh . Ali . Radiolabeled PSMA Inhibitors . Cancers . 13 December 2021 . 13 . 24 . 6255 . 10.3390/cancers13246255 . 34944875 . 8699044 . free .
  13. Ferro-Flores . Guillermina . Luna-Gutiérrez . Myrna . Ocampo-García . Blanca . Santos-Cuevas . Clara . Azorín-Vega . Erika . Jiménez-Mancilla . Nallely . Orocio-Rodríguez . Emmanuel . Davanzo . Jenny . García-Pérez . Francisco O . Clinical translation of a PSMA inhibitor for 99m Tc-based SPECT . Nuclear Medicine and Biology . May 2017 . 48 . 36–44 . 10.1016/j.nucmedbio.2017.01.012 . 28193503.
  14. Web site: PROSTASCINT . Drugs@FDA . . 19 January 2023 . en.
  15. Young . Jennifer D . Jauregui-Osoro . Maite . Wong . Wai-Lup . Cooper . Margaret S . Cook . Gary . Barrington . Sally F . Ma . Michelle T . Blower . Philip J . Aboagye . Eric O . An overview of nuclear medicine research in the UK and the landscape for clinical adoption . Nuclear Medicine Communications . December 2021 . 42 . 12 . 1301–1312 . 10.1097/MNM.0000000000001461 . 34284442 . 8584216.
  16. EAU-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer . . 23 July 2022 . 2018.
  17. Web site: EAU Guidelines - Prostate Cancer - Summary of Changes 2018 . Uroweb . . 23 July 2022 . en.
  18. News: Tagawa . Scott T . Bander . Neil H . Osborne . Joseph R . Evaluating the Current Role of PSMA PET: Utility, Availability, and Challenges . ASCO Daily News . . 2 March 2022 . 10.1200/ADN.22.200864. free.
  19. Fanti . Stefano . Goffin . Karolien . Hadaschik . Boris A . Herrmann . Ken . Maurer . Tobias . MacLennan . Steven . Oprea-Lager . Daniela E. . Oyen . Wim JG . Rouvière . Olivier . Mottet . Nicolas . Bjartell . Anders . Consensus statements on PSMA PET/CT response assessment criteria in prostate cancer . European Journal of Nuclear Medicine and Molecular Imaging . February 2021 . 48 . 2 . 469–476 . 10.1007/s00259-020-04934-4 . 32617640 . 7835167.
  20. Web site: Illuccix . Therapeutic Goods Administration . Australian Government Department of Health . 23 July 2022 . en . 24 November 2021.
  21. Web site: Submission of European Marketing Authorisation Application . Telix . 23 July 2022 . en . 1 May 2020.
  22. News: Telix's (ASX:TLX) Illuccix EU regulatory submission progresses to final stage . The Market Herald . 9 December 2021.
  23. Web site: POLATOM with a patent . Polatom . 3 October 2022.
  24. US . 11426395B2 . patent . PSMA inhibitor derivatives for labelling with 99mTc via HYNIC, a radiopharmaceutical kit, radiopharmaceutical preparations and their use in prostate cancer diagnostics . 2022-08-30 . 2022-08-30 . 2019-09-03 . 2019-04-12 . Arkadiusz Eugeniusz Sikora,Michal Maurin,Antoni Wlodzimierz Jaron,Justyna Pijarowska-Kruszyna,Monika Wyczólkowska,Barbara Janota,Marcin Radzik,Piotr Garnuszek,Urszula Karczmarczyk . NARODOWE CENTRUM BADAN JADROWYCH OSRODEK RADIOIZOTOPOW POLATOM .
  25. Web site: Review of molecular radiotherapy services in the UK . . RCP, IPEM, BNMS, RCR . 25 . 2021.
  26. Web site: Drug and Health Product Submissions Under Review (SUR): New drug submissions under review . Health Canada . 23 July 2022 . 10 March 2021.
  27. Web site: Drug Approval Package: Gallium Ga 68 PSMA-11 . U.S. Food and Drug Administration (FDA) . 16 December 2020 . 25 December 2020 . 26 January 2021 . https://web.archive.org/web/20210126195616/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212642Orig1s000TOC.cfm . live .
  28. Web site: Gallium Ga 68 PSMA-11 label . Drugs@FDA . . 23 July 2022 . December 2020.
  29. Web site: ILLUCCIX . Drugs@FDA . Food and Drug Administration . 23 July 2022.
  30. Web site: Drug Approval Package: LOCAMETZ . Drugs@FDA . . 23 July 2022.
  31. Web site: Locametz label . Drugs@FDA . . 23 July 2022 . March 2022.
  32. Web site: Drug Approval Package: PYLARIFY . Drugs@FDA . . 23 July 2022.
  33. Web site: Pylarify label . Drugs@FDA . . 23 July 2022 . May 2021.
  34. Jadvar . Hossein . Prostate-specific Membrane Antigen PET: Standard Imaging in Prostate Cancer . Radiology . 24 May 2022 . 304 . 3 . 609–610 . 10.1148/radiol.221074 . 35608452. 9434807 .
  35. Web site: Drug Approval Package: PYLARIFY . Drugs@FDA . . 7 February 2024.
  36. News: Grupo RPH fecha parceria para fabricação de radiofármaco no Brasil . Medicina S/A . 16 December 2021 . pt-BR.
  37. Illuccix Granted Use Authorisation for Prostate Cancer Imaging in Brazil . BioSpace . Telix Pharmaceuticals . 23 July 2022 . 30 November 2021.

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