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Prostate-Specific Membrane Antigen (PSMA) PET for Initial Staging of Prostate Cancer – Now That It’s Regulatory Approved, What’s Next?

Evan Y. Yu
September 01, 2021

PSMA PET imaging has now achieved regulatory approval in the United States.  On December 1, 2020, the United States (US) Food and Drug Administration (FDA) granted a limited approval to the University of California, Los Angeles and the University of California, San Francisco, for 68Ga-PSMA-11 PET imaging for patients “with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy” and for patients with “suspected prostate cancer recurrence based on elevated serum PSA levels.”1  More recently, on May 27, 2021, a second PSMA imaging agent, PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL), received FDA approval for the exact same indication.2  Although neither 68Ga-PSMA-11 and PYLARIFY® (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) are widely available yet, both likely soon will be, and they will change how we think about and treat patients with prostate cancer and both high-risk localized disease and biochemical recurrence.


Dr. Evan Yu, MD

Evan Yu, MD

Evan Yu, a medical oncologist, treats prostate, bladder, and testicular cancer, and is passionate about providing a personalized medical approach to a selection of novel therapies as well as understanding biologic mechanism of drug sensitivity and resistance.

Clinical Expertise

Medical Oncology, Translational Research, Novel molecular targeted agents, Biomarkers, Imaging (PET scans, MRI), Bone health.

  • Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine
  • Member, Clinical Research Division, Fred Hutchinson Cancer Research Center
  • Clinical Research Director, Genitourinary Oncology, Seattle Cancer Care Alliance
  • Medical Director, Clinical Research Service, Fred Hutchinson Cancer Research Consortium
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