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

NCT04457232 — Phase 1, Active not recruiting, 30 participants, Jonsson Comprehensive Cancer Center

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

Registry	NCT04457232, acronym FAPI PET Prost
Status	Active not recruiting
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	30 (Actual)
Sponsor	Jonsson Comprehensive Cancer Center (Other); collaborators: Prostate Cancer Foundation
Conditions	Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma
Interventions	Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography (Procedure, other)
Dates	start 2020-09-09, primary completion 2023-05-30, completion 2027-05-30 (estimated), first posted 2020-07-07, last updated 2026-08-20
Locations	1 site in United States

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Basic Science (68Ga-FAPi-46 PET/CT)	Experimental	Procedure: Computed Tomography; Other: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography	Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.

Computed Tomography (Procedure), also known as CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography: Undergo PET/CT imaging
Gallium Ga 68 FAPi-46 (Other), also known as 68Ga-FAPi-46, Gallium-68-FAPi-46: Given IV
Positron Emission Tomography (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging: Undergo PET/CT imaging

+Outcome measures

Primary outcomes

To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer [60 minutes after tracer injection]: To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values \[SUV\], SUVmean and SUVmax.

Secondary outcomes

To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue [Up to date of surgery (range 1-60 days)]: 68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging [60 minutes after tracer injection]: The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax) and tested for correlation.

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

* 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)

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
UCLA / Jonsson Comprehensive Cancer Center	Los Angeles, California	United States

+Investigators

Jeremie Calais, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center

My Notes

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