NCT04457232

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started Sep 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2020May 2026

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

June 30, 2020

Last Update Submit

July 11, 2025

Conditions

Metastatic Malignant Neoplasm in the Prostate GlandProstate CarcinomaRecurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging

    60 minutes after tracer injection

Study Arms (1)

Basic Science (68Ga-FAPi-46 PET/CT)

EXPERIMENTAL

Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.

Procedure: Computed TomographyOther: Gallium Ga 68 FAPi-46Procedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT imaging

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Basic Science (68Ga-FAPi-46 PET/CT)
Gallium Ga 68 FAPi-46OTHER

Given IV

Also known as: 68Ga-FAPi-46, Gallium-68-FAPi-46
Basic Science (68Ga-FAPi-46 PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT imaging

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Basic Science (68Ga-FAPi-46 PET/CT)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

FAPI-46Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jeremie Calais

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

September 9, 2020

Primary Completion

May 30, 2023

Study Completion (Estimated)

May 30, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

US(1)