[177Lu] Lu-PSMA-I&T for prostate cancer radioligand therapy: A radiopharmacy's journey from synthesis to cost-effectiveness.

Radioligand therapy (RLT) with [177Lu]-Lu-radiolabeled pharmaceuticals targeting PSMA is a promising treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC), with the potential to improve outcomes and quality of life. However, the introduction of these innovative therapies into standard clinical practice presents significant challenges for public hospitals, especially in terms of cost management and sustainability. This study aimed to describe our experience with the "in-house" production and quality control of [177Lu]Lu-PSMA-I&T, a galenic radiopharmaceutical with a dedicated monograph in the European Pharmacopeia. The reproducibility of reaction yields and the maintenance of quality specifications were rigorously assessed across all manufactured batches and an economic evaluation was also conducted to determine the feasibility of routine production from a cost-effectiveness perspective. All production batches showed consistently high radiochemical purity, which is of crucial importance for patient safety and therapeutic efficacy. Our results show that the in-house production of the radiopharmaceutical complies all the requirements defined by the relevant monograph. The cost analysis is favorable when production is intended for internal use within a nuclear medicine department supported by a well-structured radiopharmacy and trained staff.