30 Participants Needed

FAPi PET/CT Imaging for Prostate Cancer

(FAPI PET Prost Trial)

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Overseen ByEthan Lam
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot have any new prostate therapy between certain imaging procedures.

What data supports the effectiveness of the treatment FAPi PET/CT Imaging for Prostate Cancer?

Research shows that a similar imaging probe, [68Ga]Ga-FAPI-PSMA, effectively targets prostate cancer cells and provides clear images for diagnosis, indicating that FAPi PET/CT imaging could be effective for prostate cancer as well.12345

Is FAPi PET/CT imaging safe for humans?

Research indicates that FAPi PET/CT imaging, using gallium-68-labeled compounds, is generally safe in humans, with low radiation doses and rapid clearance from the body. This has been observed in studies involving various conditions, including prostate and gastrointestinal cancers.12356

How is Gallium Ga 68 FAPi-46 different from other prostate cancer imaging drugs?

Gallium Ga 68 FAPi-46 is unique because it targets fibroblast activation protein (FAP), which can help detect prostate cancer that may not be visible with other imaging agents like PSMA or FDG. This makes it particularly useful for identifying certain types of prostate cancer that are not easily detected by standard imaging methods.12357

Research Team

stromal biomarker for prostate cancer ...

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patients can provide written informed consent
I had a 68Ga-PSMA-11 PET/CT scan within the last 3 months.
I am scheduled for surgery or a biopsy for prostate cancer.
See 1 more

Exclusion Criteria

I have not started new prostate treatments between my PSMA and FAPI PET/CT scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive 68Ga-FAPi-46 intravenously and undergo PET/CT imaging over 20-50 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

  • Computed Tomography
  • Gallium Ga 68 FAPi-46
  • Positron Emission Tomography
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Prostate Cancer Foundation

Collaborator

Trials
52
Recruited
3,000+

Findings from Research

The radiotracer [68Ga]Ga-DATA5m.SA.FAPi can be prepared easily at room temperature and shows high stability and affinity for FAP, making it a promising tool for imaging in cancer diagnostics.
In clinical trials with six prostate cancer patients, [68Ga]Ga-DATA5m.SA.FAPi demonstrated rapid and stable tumor uptake, supporting its potential as an effective diagnostic tool for FAP imaging in tumors.
Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature.Escudero-Castellanos, A., Kurth, J., Imlimthan, S., et al.[2023]
68Ga-FAPI is a new PET imaging agent that shows promise for detecting tumors, indicating its potential utility in cancer diagnosis.
The study highlights the use of 68Ga-FAPI PET/CT imaging in a patient with Baastrup disease and esophageal cancer, suggesting that FAPI uptake may also be relevant in nonmalignant conditions.
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer.Yang, X., Liu, Y., Chen, J., et al.[2023]
The novel imaging probe [68Ga]Ga-FAPI-PSMA shows high affinity for prostate cancer cells, making it effective for diagnostic imaging, with IC50 values of 4.73 nM for PSMA and 2.10 nM for FAP expressing cells.
In vivo studies demonstrated that [68Ga]Ga-FAPI-PSMA rapidly accumulates in prostate tumors and provides optimal imaging results at 1 hour post-injection, while also having a relatively low radiation dose compared to other imaging probes.
Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging.Wang, P., Wang, S., Liu, F., et al.[2023]

References

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. [2023]
68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. [2023]
Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. [2023]
Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. [2021]
Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. [2023]
Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]
68 Ga-FAPI PET/CT Detected Non-PSMA/FDG-Avid Primary Tumor in De Novo Metastatic Prostate Cancer. [2023]