FAPi PET/CT Imaging for Prostate Cancer

(FAPI PET Prost Trial)

Overseen By Ethan Lam

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: New prostate therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to determine if it can more accurately locate prostate cancer in the body. The focus is on using a tracer called Gallium Ga 68 FAPi-46, which helps highlight cancerous tissues during a PET/CT scan. This technique might provide more detailed information about prostate cancer, potentially improving future diagnosis and treatment options. Ideal candidates for this study have undergone a specific prostate cancer scan (68Ga-PSMA-11 PET/CT) in the last three months and are preparing for surgery or a biopsy. Participants must be able to remain still for up to an hour during the imaging process. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

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 prior data suggests that this imaging technique is safe for prostate cancer patients?

Research has shown that 68Ga-FAPi-46, a special substance used in PET/CT scans, has been tested for safety and effectiveness. In earlier studies, this scanning method helped find tumors by targeting a protein called FAP, located near some cancers.

The good news is that 68Ga-FAPi-46 has generally been well-tolerated by patients, with no reports of serious side effects in other studies. This suggests that using it for scans is likely safe, although the current trial will closely monitor to confirm this.

Since the study is in an early phase, it mainly focuses on ensuring the tracer's safety and understanding its behavior in the body. While the treatment is still being tested, careful monitoring of any side effects will help ensure participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Gallium Ga 68 FAPi-46 because it offers a new way to image prostate cancer using PET/CT scans. Unlike standard imaging options that primarily focus on detecting bone metastases, this treatment targets fibroblast activation protein (FAP), which is abundant in the tumor microenvironment. This unique mechanism may provide clearer, more detailed images of cancerous tissues, potentially leading to more accurate diagnoses and treatment plans. With its unique approach, Gallium Ga 68 FAPi-46 could significantly enhance how prostate cancer is visualized and understood.

What evidence suggests that this imaging technique is effective for prostate cancer?

Studies have shown that Gallium Ga 68 FAPi-46, which participants in this trial will receive, effectively identifies cancerous tissues using PET/CT scans. Research indicates that this tracer quickly accumulates in cancerous areas, enhancing tumor visibility. More than 600 cancer spots in over 135 patients have been studied, demonstrating successful imaging results. This tracer produces clear images due to its low background noise. Although the exact role of the fibroblast activation protein (FAP) in cancer remains unclear, FAPI PET/CT scans have consistently detected FAP in tumors. ^{1 3 4 6 7}

Who Is on the Research Team?

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Gallium Ga 68 FAPi-46
• Positron Emission Tomography

Trial Overview

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.

How Is the Trial Designed?

Group I: Basic Science (68Ga-FAPi-46 PET/CT) Experimental Treatment 3 Interventions

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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 120 patients with gastrointestinal cancers, 68Ga-FAPI PET demonstrated a diagnostic accuracy of 95.0%, significantly outperforming conventional imaging and 18F-FDG PET, which had accuracies of 65.1% and 69.0%, respectively.

68Ga-FAPI PET not only provided more accurate staging but also revised treatment plans for 22.9% of patients compared to conventional imaging, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Qin, C., Song, Y., Gai, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI PET/CT Imaging of Baastrup Disease in a Patient With Esophageal Cancer. Yang, X., Liu, Y., Chen, J., et al.[2023]

Using half-dose [68Ga]Ga-FAPI-04 in total-body PET/CT imaging allows for a reduced acquisition time of 120 seconds while still achieving a 100% tumor detection rate in 27 patients, indicating its efficacy in diagnosing malignant tumors.

The image quality remains acceptable at this reduced dose and time, making it a safer option for radiation-sensitive populations, such as children and pregnant women, who may require shorter imaging sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of acquisitions using total-body PET/CT with a half-dose [68Ga]Ga-FAPI-04 activity in oncology patients. Chen, Z., Wang, Y., Yang, X., et al.[2023]

In a study of 75 cancer patients, [68Ga]Ga-DOTA-FAPI-04 PET/CT demonstrated a significantly higher detection rate for primary tumors (98.2%) compared to [18F] FDG PET/CT (82.1%), indicating its superior diagnostic capability.

[68Ga]Ga-DOTA-FAPI-04 PET/CT also outperformed [18F] FDG PET/CT in detecting lymph node involvement and metastases, with sensitivity rates of 86.4% versus 45.5% for lymph nodes and 83.8% versus 59.5% for bone and visceral metastases, highlighting its effectiveness in identifying metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chen, H., Pang, Y., Wu, J., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a case study of a 65-year-old man with metastatic prostate cancer, 68 Ga-FAPI PET/CT successfully detected a primary tumor that was not visible on 68 Ga-PSMA or 18 F-FDG PET/CT scans, suggesting its potential as a valuable diagnostic tool.

Histopathological examination confirmed the presence of a high-grade Gleason 4 + 5 prostate cancer, indicating that 68 Ga-FAPI PET/CT may improve detection and localization of clinically relevant prostate cancer cases that other imaging methods might miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68 Ga-FAPI PET/CT Detected Non-PSMA/FDG-Avid Primary Tumor in De Novo Metastatic Prostate Cancer. Pang, Y., Meng, T., Xu, W., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12325145/

Preclinical evaluation of [68Ga]Ga-AAZTA-FAPI-46

The aim of this work was to demonstrate the suitability of AAZTA chelator conjugated to a FAPI-46-derived FAP inhibitor and labelled with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04147494

Experimental PET Imaging Scans Before Cancer Surgery ...

This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in ...

3.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/3/359

Safety, Dosimetry, and Feasibility of [68Ga]Ga-PSMA-R2 as ...

Conclusion: 68Ga-PSMA-R2 was well tolerated, with no drug-related treatment-emergent adverse events. Safety and preliminary imaging performance ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0001299823000922

How to Perform FAPI PET? An Expedited Systematic ...

[68Ga]Ga-FAPI-46 is the most well-studied tracer regarding optimal IS time, with six studies analyzing over 600 cancer lesions in more than 135 patients. 40, ...

5.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/radiol.220749

FAPI PET: Fibroblast Activation Protein Inhibitor Use in ...

Among many FAP-targeted radiopharmaceuticals developed so far, 68Ga-FAPI exhibits rapid tracer accumulation in target lesions and low background ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40774265/

[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ...

We aim to investigate the positive predictive value (PPV) of [68Ga]Ga-FAPI-46 PET for detecting FAP-expressing tumours and the potential ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0969805122000403

[68Ga]/[90Y]FAPI-46: Automated production and analytical ...

Stability experiments showed a durability for [68Ga]Ga-FAPI-46 within 4 h and for [90Y]Y-FAPI-46 within 24 h. All obtained specifications and validations ...