Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation (FAPI PET Prost)

October 11, 2023 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic Science (68Ga-FAPi-46 PET/CT)
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
Procedure: Computed Tomography
Undergo PET/CT imaging
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Other: Gallium Ga 68 FAPi-46
Given IV
Other Names:
  • 68Ga-FAPi-46
  • Gallium-68-FAPi-46
Procedure: Positron Emission Tomography
Undergo PET/CT imaging
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
Time Frame: 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.
60 minutes after tracer injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Up to date of surgery (range 1-60 days)
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
Time Frame: 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.
60 minutes after tracer injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Prostate Cancer Foundation

Investigators

  • Principal Investigator: Jeremie Calais, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Estimated)

September 9, 2024

Study Completion (Estimated)

September 9, 2025

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-000177 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)
  • NCI-2020-02712 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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