[177Lu] Lu-PSMA-I&T for Prostate Cancer Radioligand Therapy: A Radiopharmacy's Journey from Synthesis to Cost-Effectiveness

Background Radioligand therapy (RLT) whit [ ¹⁷⁷ Lu] Lu-radiolabeled pharmaceuticals targeting PSMA represents a promising innovation to improve the health and quality of life of patients with metastatic castration-resistant prostate cancer (mCRPC). However, the introduction of these innovative therapies into standard clinical practice presents significant challenges for public hospital, especially in terms of cost management and sustainability. The purpose of this study is to evaluate the sustainability and cost-effectiveness of producing [ ¹⁷⁷ Lu] Lu-PSMA-I&T in a hospital-based radiopharmacy, focusing on process optimization and quality controls that meet European Pharmacopoeia standards. Different modules were used for multiple synthesis runs of [ ¹⁷⁷ Lu] Lu-PSMA-I&T, and each batch underwent comprehensive quality control tests. Results The results of our study showed that a radiochemical purity exceeding 99% was achieved in all in-house produced batches, reinforcing the viability of this approach for hospitals seeking to deliver high-quality radiopharmaceuticals. Conclusions From an economic standpoint, to make [ ¹⁷⁷ Lu] Lu-PSMA-I&T in-house is at least three times more cost-effective than choosing commercial options. In a nuclear medicine department with well-structured radiopharmacy and trained staff, this alternative offers significant benefits for healthcare systems and enhances the economic sustainability of radioligand therapy. This allows a greater number of patients with mCRPC to receive treatment without compromising therapeutic efficacy.