Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation

Running, not enrolling · Phase 1

Conditions studied: Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma

In brief

This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.

Key facts

Study ID

NCT04457232

Run by

Jonsson Comprehensive Cancer Center

People needed

30

Starts

2020-09-09

Expected to finish

2027-05-30

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment
• Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
• Patients can provide written informed consent
• Patients are able to remain still for duration of imaging procedure (up to one hour)

You may not qualify if…

• Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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