From Medical Isotopes to Clinical Trials: A Review of Two Theranostic Solutions

Abstract

The Centre for Probe Development and Commercialization (CPDC) specializes in translating radiopharmaceuticals from laboratory to clinic, to commercial marketplace. DOTATATE and PSMA are two examples of theranostic drugs that are manufactured at the CPDC and have been brought to clinical trials in Ontario. [Ga-68]-DOTATATE and [Lu-177]-DOTATATE are used as diagnostic and therapeutic counterparts, offering a theranostic solution for patients. Similarly, [F-18]-PSMA and [Lu-177]-PSMA are diagnostic and therapeutic agents. Both drugs bind to specific peptide receptors which are over-expressed on tumor cells, thereby allowing targeted tumor therapy. [Lu-177]-DOTATATE is used for the treatment of neuroendocrine tumors (NETs), while [Lu-177]-PSMA is used for the treatment of prostate cancer. The CPDC routinely manufactures both agents to treat Canadian patients. Beginning with isotope, the CPDC has developed a GMP manufacturing process to manufacture both diagnostic and therapeutic agents, ensuring consistent and optimal labeling, radioactive concentration, yield, and radiochemical purity for each batch of product.