18F-PSMA PET/CT in the staging of primary prostate cancer and the restaging of recurrent prostate cancer: evidence synthesis to support a generic justification decision

Dullea A, O'Sullivan L, O'Brien K, McGarry M, Harrington P, Walsh K, Carrigan M, Ahern S, O'Shea, M, Larkin L, Spillane D, Ryan M
Record ID 32018005545
Authors' objectives: Prostate specific membrane antigen (PSMA)-targeted diagnostic radiotracers are increasingly being applied in clinical practice worldwide for the diagnosis and or staging of prostate cancer. In May 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of piflufolastat (18F) (formerly known as 18F-DCFPyL) (Pylclari™), a fluorine-18 labelled small-molecule PSMA inhibitor for the primary staging of patients with high-risk prostate cancer and to localise the recurrence in those with suspected recurrence following initial treatment with curative intent.(2) Other available 18F radiopharmaceuticals include 18F-PSMA-1007 and 18F-rhPSMA-7. The Blackrock Clinic submitted an application for generic justification of this type of practice which they intend to generally adopt into clinical practice. Therefore, consistent with the requirements under the European Union Basic Safety Standards for the Protection Against Dangers from Medical Exposure to Ionising Radiation (Euratom), which were transposed into Irish law under Statutory Instrument (SI) 256 in January 2019, it requires generic justification before it can be generally adopted.
Project Status: Completed
Year Published: 2023
Requestor: Blackrock Clinic, Ireland
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: Ireland
MeSH Terms
  • Prostatic Neoplasms
  • Positron Emission Tomography Computed Tomography
  • Diagnostic Imaging
  • Fluorine Radioisotopes
  • Radiopharmaceuticals
  • Neoplasm Staging
  • Prostate Cancer
  • F18 PSMA PET
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Contact Email: info@hiqa.ie
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