Health Problem: Prostate cancer is the most common cancer diagnosis and the second leading cause of cancer-related deaths in men in the United States. Within 10 years of successful treatment for localized prostate cancer, serum prostate specific antigen (PSA) levels will rise to detectable levels in approximately 15% to 40% of men. Most often, a rising PSA is an indication of prostate cancer recurrence, although uncommonly this phenomenon may be a benign PSA-only relapse due to residual normal prostate tissue after surgery and/or radiation.

Technology Description: For fluciclovine positron emission tomography-computed tomography (PET-CT) and prostate-specific membrane antigen (PSMA) ligand PET-CT, patients are injected intravenously with a radiotracer such as fluorine-18-labeled fluciclovine (18F-fluciclovine) or gallium-68-labeled PSMA ligand (68Ga-PSMA ligand). Fluciclovine is similar to the amino acid leucine and PSMA ligands are chemicals that bind specifically to the PSMA protein. After a delay to allow cellular uptake or binding of the radiotracer, imaging is performed in the PET-CT scanner. Decay of the radiotracer generates gamma rays that are detected by the scanner to pinpoint sites in the body that have accumulated radiotracer.

Controversy: Although 18F-fluciclovine and 68Ga-PSMA ligands for PET-CT have been used in clinical practice, there are concerns regarding their diagnostic accuracy, especially in men who have low PSA values.

Key Questions:              

  • Do fluciclovine PET-CT and PSMA ligand PET-CT provide accurate diagnostic information in patients who have suspected recurrence of prostate cancer?
  • Does information obtained from fluciclovine PET-CT and PSMA ligand PET-CT improve patient management or outcomes?
  • How do fluciclovine PET-CT and PSMA ligand PET-CT compare with alternative technologies?
  • Are fluciclovine PET-CT and PSMA ligand PET-CT safe?
  • Have definitive patient selection criteria been established for fluciclovine PET-CT and PSMA ligand PET-CT?

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