NCT04457232

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metastatic Malignant Neoplasm in the Prostate Gland
• Prostate Carcinoma
• Recurrent Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT imaging
OTHER	Gallium Ga 68 FAPi-46	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT imaging

Timeline

• Start date: 2020-09-09
• Primary completion: 2023-05-30
• Completion: 2026-05-30
• First posted: 2020-07-07
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study