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68Ga-PSFA Advanced Drug Monograph

Published:May 13, 2025

Generic Name

68Ga-PSFA

68Ga-PSFA

Name (English): 68Ga-PSFA

Indication: Prostate cancer imaging

Target: Prostate-Specific Membrane Antigen (PSMA) and Fibroblast Activation Protein (FAP)

Mechanism of Action: 68Ga-PSFA is a dual-targeting positron emission tomography (PET) tracer. The PSMA targeting moiety allows for the detection of prostate cancer cells, while the FAP targeting component aims to image the tumor microenvironment, particularly cancer-associated fibroblasts (CAFs).

Clinical Applications:

  • Detection and staging of primary prostate cancer
  • Detection of recurrent prostate cancer
  • Patient selection for PSMA-targeted therapy
  • Potentially useful in imaging PSMA-negative or low-expressing tumors due to FAP targeting

Dosage and Administration: Administered intravenously as a bolus injection. Dosage varies depending on the imaging protocol and patient characteristics.

Pharmacokinetics: Undergoes rapid distribution and clearance. Imaging is typically performed within 60-90 minutes post-injection.

Efficacy: Studies suggest higher detection rates and visual assessment efficacy compared to 68Ga-PSMA-11 PET/CT, particularly in patients with recurrent disease. May show lower uptake in primary tumors and bone metastases compared to 68Ga-PSMA-11.

Safety: The safety profile is still under investigation. As a radioactive tracer, radiation exposure is a concern and should be minimized.

Adverse Reactions: No significant adverse reactions have been widely reported to date, but further research is needed.

Contraindications: No absolute contraindications are well-established. Relative contraindications may include pregnancy and breastfeeding.

Precautions: Standard precautions for handling radioactive materials should be followed. Hydration is recommended to promote tracer clearance.

Interactions: No known drug interactions have been reported.

Storage: Not applicable as it is prepared and administered by nuclear medicine departments.

Regulatory Status: Investigational agent; not yet approved for routine clinical use in most regions.

Note: This report provides a summary of the currently available information. Further research is ongoing to fully characterize the clinical utility and safety of 68Ga-PSFA. Consult relevant clinical trials and regulatory guidelines for the most up-to-date information.

Published at: May 13, 2025

This report is continuously updated as new research emerges.

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