This study is in progress, not accepting new patients

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

a study on Malignant Neoplasm Prostate Cancer Carcinoma Neoplasms

Eligibility: for males ages 18 years and up (full criteria)
Location: at UCLA
Dates: study started September 2020
completion around May 30, 2025
Principal Investigator: by Jeremie Calais (ucla)

Jeremie Calais

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.

SECONDARY OBJECTIVES:

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.

Keywords

Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma, Carcinoma, Prostatic Neoplasms, Neoplasms, FAPI-46, Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography, Basic Science (68Ga-FAPi-46 PET/CT)

Eligibility

You can join if…

Open to males ages 18 years and up

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 CAN'T join if...

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

Location

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

Lead Scientist at University of California Health

Jeremie Calais (ucla)
Nuclear medicine physician specialized in cancer imaging and theranostics. Associate Professor, Department of Molecular and Medical Pharmacology at UCLA Director, Theranostics Program, Ahmanson Translational Theranostics Division at UCLA Faculty Member of the Jonsson Comprehensive Cancer Center at UCLA. Faculty Member of the Institute of Urologic Oncology at UCLA.

Details

Status: in progress, not accepting new patients
Start Date: September 2020
Completion Date: May 30, 2025 (estimated)
Sponsor: Jonsson Comprehensive Cancer Center
ID: NCT04457232
Phase: Phase 1 research study
Study Type: Interventional
Participants: About 30 people participating
Last Updated: July 2024