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

Prostate Carcinoma Clinical Trial

— FAPI PET Prost  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04457232
• Other study ID #: 20-000177
• Secondary ID: NCI-2020-0271220
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 9, 2020
• Est. completion date: September 9, 2025

Study information

• Verified date: October 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 9, 2025
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT imaging

Other:
• Gallium Ga 68 FAPi-46
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT imaging

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Prostate Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer	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.	60 minutes after tracer injection
Secondary	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	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.	Up to date of surgery (range 1-60 days)
Secondary	To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging	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.	60 minutes after tracer injection