Abstract
Radiopharmaceuticals targeting the prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer. [68Ga]Ga-PSMA-11 has been the forerunner but a [18F]F-PSMA ligand has been developed because of the intrinsic advantages of Fluorine-18. Fluorine-18 labelled compounds are usually prepared in centers with an on-site cyclotron. Since our center has not an on-site cyclotron, we decided to verify the feasibility of producing the experimental 18F-labelled radiopharmaceutical [18F]F-PSMA-1007 with [18F]F- from different external suppliers. A quality agreement has been signed with two different suppliers, and a well-established and correctly implemented quality assurance protocol has been followed. The [18F]F- was produced with cyclotrons, on Nb target, but with different beam energy and current. Extensive validation of the [18F]F-PSMA-1007 synthesis process has been performed. The aim of this paper was the description of all the quality documentation which allowed the submission and approval of the Investigational Medicinal Product Dossier (IMPD) to the Competent Authority, addressing the quality problems due to different external suppliers. The result indicates that no significant differences have been found between the [18F]F- from the two suppliers in terms of radionuclidic and radiochemical purity and [18F]F- impacted neither the radiochemical yield of the labelling reaction nor the quality control parameters of the IMP [18F]F-PSMA-1007. These results prove how a correct quality assurance system can overcome some Regulatory Authorities issue that may represent an obstacle to the clinical use of F-18-labelled radiopharmaceuticals without an on-site cyclotron.
Highlights
In the last years, the prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer [1,2]
One of the first radiopharmaceuticals for this purpose was [68 Ga]Ga-PSMA-11, which has been included in national and european prostate cancer guidelines [3] based on the diagnostic superiority of [68 Ga]GaPSMA-11 compared to [11 C]C-choline and [18 F]F-choline already reported in the scientific literature [4]
The results of the quality controls of each batch of PSMA-1007 are reported in the Certificate of Analysis (CoA) that is supplied with each batch
Summary
The prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer [1,2]. Pharmaceuticals 2021, 14, 599 patients who can be imaged and high positron energy (about 1899 KeV) that can affect the quality of imaging PET. Does not allow for late acquisition of images [6] For these reasons, the clinical research aimed at 18 F-labeled compounds, first of all [ F]F-PSMA-1007 [7], that, compared to Gallium-68, allow simpler management of radiopharmaceuticals and higher quality of imaging due to lower positron endpoint energy (about 633 KeV), a longer half life (about 110 min), the possibility of large scale production and distribution, and a very low accumulation in the urinary system, that makes [18 F]F-PSMA-1007 suitable to identify small lesions in the pelvis or for local recurrence
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