Piflufolastat F 18

Prostate cancer is the most common non-cutaneous malignancy affecting men in North America - despite this, an ongoing challenge in prostate cancer therapy is the difficulty in imaging the extent and location of tumor metastases and recurrences. The images generated by positron emission tomography (PET) are less detailed than those obtained via MRI or CT, but are more sensitive and can reveal cancerous tissue in any area of the body provided the tissue is expressing the appropriate target protein. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein expressed in many tissues that plays a role in folate uptake and neurotransmitter release - it is expressed in the prostate at levels roughly 1000-fold greater than elsewhere in the body, and even higher in prostate cancer tissue. As such, it has become a desirable target for PET imaging of prostate cancer tissues.

Piflufolastat F18, also called [F-18]-DCFPyL, is a urea-based radiopharmaceutical that binds to PSMA and allows for the visualization of cancerous prostate tissue. It was first approved by the FDA in May 2021 under the brand name Pylarify and aims to allow for earlier and more accurate detection of suspected prostate cancer metastases or recurrences. On July 28, 2023, the EMA also approves Piflufolastat F18 under the brand name PYLCLARI for primary staging or localizing recurrence of prostate cancer.

Piflufolastat F18 is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and for men with a suspected recurrence of prostate cancer based on elevated prostate-specific antigen (PSA) levels by the FDA. It is approved by the EMA for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy and for localizing recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.