for males ages 18 years and up (full criteria)
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)



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.

Official Title

PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation


PRIMARY OBJECTIVE: I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer. SECONDARY OBJECTIVES: I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively. II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11. OUTLINE: Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.


Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma, Carcinoma, Prostatic Neoplasms, Neoplasms, FAPI-46, Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography, Basic Science (68Ga-FAPi-46 PET/CT)


You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join if...

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


  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

  • Jeremie Calais (ucla)
    HS Associate Clinical Professor, Molecular and Medical Pharmacology, Medicine. Authored (or co-authored) 93 research publications


accepting new patients
Start Date
Completion Date
Jonsson Comprehensive Cancer Center
Phase 1 research study
Study Type
Expecting 30 study participants
Last Updated