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Imaging Agent

FAPi PET/CT Imaging for Prostate Cancer (FAPI PET Prost Trial)

Phase 1
Waitlist Available
Led By Jeremie Calais
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to date of surgery (range 1-60 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new imaging technique to see if it can detect prostate cancer. The technique uses a tracer called 68Ga-FAPi-46 which is taken up by some cancer cells. If successful, this technique could provide additional information about various types of cancer in the future.

Who is the study for?
This trial is for men with prostate cancer who've had a PSMA PET/CT scan within the last 3 months and are scheduled for surgery or biopsy of their cancer. They must be able to give consent and stay still for up to an hour during imaging.
What is being tested?
The study tests a new imaging method called FAPI PET/CT, which uses a tracer (68Ga-FAPi-46) to see how well it highlights prostate cancer in the body by targeting FAP, a protein often found near tumors.
What are the potential side effects?
Since this is an imaging study using Gallium Ga 68 FAPi-46, side effects may include discomfort at injection site or allergic reactions but generally, PET/CT scans have minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery or a biopsy for prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to date of surgery (range 1-60 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to date of surgery (range 1-60 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
Secondary study objectives
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
Malignant Neoplasms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Basic Science (68Ga-FAPi-46 PET/CT)Experimental Treatment3 Interventions
Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,164 Total Patients Enrolled
31 Trials studying Prostate Cancer
2,490 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
48 Previous Clinical Trials
2,837 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,900 Patients Enrolled for Prostate Cancer
Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
7 Previous Clinical Trials
1,343 Total Patients Enrolled

Media Library

Gallium Ga 68 FAPi-46 (Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04457232 — Phase 1
Prostate Cancer Research Study Groups: Basic Science (68Ga-FAPi-46 PET/CT)
Prostate Cancer Clinical Trial 2023: Gallium Ga 68 FAPi-46 Highlights & Side Effects. Trial Name: NCT04457232 — Phase 1
Gallium Ga 68 FAPi-46 (Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457232 — Phase 1
~6 spots leftby Nov 2025
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