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.
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.
[7] 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.
[9] A 2024 overview of reviews published in Seminars of Nuclear Medicine concluded that while evidence gaps remain for some outcomes and most systematic reviews are at high or unclear risk of bias, the evidence base is broadly supportive of 18-F PSMA PET/CT in patients with high-risk prostate cancer or biochemical recurrence [10] In part thanks to the wide range of similar PSMA radiopharmaceuticals,[4][16] approval by regulatory authorities is at varying stages.
[17][18][19][20] A kit for manufacture of a 68Ga-PSMA-11 product, branded Illucix, was approved by Australia's Therapeutic Goods Administration (TGA) in 2021.
[21] 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.
[28] Listed indications include suspected metastasis prior to initial treatment, and recurrence of prostate cancer (based on elevated serum prostate-specific antigen (PSA) level).