MedTrace Logo

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

NCT04457232 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Computed Tomography

Undergo PET/CT imaging

OTHER

Gallium Ga 68 FAPi-46

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT imaging

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jeremie Calais · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2023-05-30
Completion
2026-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457232 on ClinicalTrials.gov