S.R.Y. has successfully developed and implemented a production line for 18F-PSMA-1007, a novel fluorine-18 labeled PSMA (prostate specific membrane antigen) ligand facilitating the diagnosis of prostate cancer (PC) and its metastases. in the world for prostate cancer imaging
Since its introduction in 2011, 68Ga-PSMA-11 has been commonly used for PSMA-targeted imaging, mostly in Europe and Asia, and has revolutionized the field of PC imaging and treatment. 68Ga-PSMA-11 accumulates in PC lesions while clearing from non-target tissues, resulting in high diagnostic sensitivity and ability to diagnose metastases, including in small lymph nodes. Nonetheless, 68Ga-PSMA-11 has several drawbacks, namely:
- Renal excretion, leading to high activity in the bladder, which might obscure locally recurrent lesions.
- A relatively short half-life, which limits its distribution to distant centers.
- Reliance on third parties for supply of generators.
- Limited yields, allowing production of ~4 doses per batch.
- Relatively lower spatial resolution images of gallium-68 compared to fluorine-18
As of 2017, the availability and price of 68Ge/68Ga generators have been challenging. At the same time, a novel fluorine-18 labeled PSMA ligand, 18F-PSMA-1007, was launched, and has since been widely adopted by nuclear medicine and urology physicians. This PET ligand offers several advantages compared to 68Ga-PSMA-11, including:
- Mostly hepatobiliary clearance, resulting in low accumulation in the bladder and improved visualization of lesions within and around the prostatic bed.
- Higher spatial resolution images owing to the use of fluorine-18 rather than gallium-68.
- Cyclotron-mediated production of fluorine-18, enabling high yields without relying on third parties
- Distribution of the radiopharmaceutical to distant centers owing to the longer half-life of fluorine-18 (~ 110 min).
In light of these significant advantages, as of 2017, S.R.Y. has initiated a routine production line of 18F-PSMA-1007.
