[⁶⁸Ga]PSMA-11 for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer

Theranostics targeting prostate-specific membrane antigen (PSMA) represent a new targeted approach for prostate cancer care that combines diagnostic and therapeutic radiopharmaceuticals to diagnose and treat the disease. Positron emission tomography (PET) is the imaging method of choice and several diagnostic radiopharmaceuticals for quantifying PSMA have received FDA approval and are in clinical use. [⁶⁸Ga]Ga-PSMA-11 is one such imaging agent and the focus of this article. One beta-emitting radioligand therapy ([¹⁷⁷Lu]Lu-PSMA-617) has also received FDA approval for prostate cancer treatment, and several other alpha- and beta-emitting radioligand therapies are in clinical trials. Theranostics targeting PSMA in men with prostate cancer are discussed with a focus on use of [⁶⁸Ga]Ga-PSMA-11 for imaging PSMA-positive lesions in men with prostate cancer. The review covers [⁶⁸Ga]Ga-PSMA-11 manufacture, current regulatory status, comparison of [⁶⁸Ga]Ga-PSMA-11 to other imaging techniques, clinical updates, and emerging applications of artificial intelligence for [⁶⁸Ga]Ga-PSMA-11 PET. [⁶⁸Ga]Ga-PSMA-11 is used in conjunction with a PET/CT scan to image PSMA positive lesions in men with prostate cancer. It is manufactured by chelating precursor with⁶⁸Ga, either from a generator or cyclotron, and has regulatory approval around the world. It is widely used clinically in conjunction with radioligand therapies like [¹⁷⁷Lu]Lu-PSMA-617.