FAPI PET/MRI for Prostate Cancer

SH
RS
Overseen ByRadiology Studies
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial examines how a new drug, FAPI (Gallium 68-labeled fibroblast activation protein inhibitor), aids in diagnosing and tracking prostate cancer. Researchers aim to observe FAPI's interaction with cancer cells during scans, potentially enhancing doctors' understanding and monitoring of the disease. Individuals with a known diagnosis of prostate cancer who have recently undergone or are scheduled for a PSMA PET scan might be suitable candidates. Participants will undergo two PET/MRI scans, each lasting up to 2.5 hours. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in prostate cancer diagnosis.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you require mild, oral anxiolytics (medications that reduce anxiety) for the MRI, you can still participate as long as you have your own prescription and follow the consent process before taking them.

What prior data suggests that this method is safe for prostate cancer patients?

Research has shown that FAPI PET imaging, which uses a special protein blocker, is generally safe. Studies have found that a tracer called Gallium 68-labeled FAPI is both safe and effective for cancer imaging. Tested across various cancer types, patients have tolerated it well. No major safety issues emerged in these studies, suggesting that FAPI PET scans are likely well-tolerated by clinical trial participants.12345

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, which often include surgery, radiation, and hormone therapy, FAPI (Fibroblast Activation Protein Inhibitor) offers a novel approach by using a radiotracer during PET imaging. Researchers are excited about FAPI because it targets fibroblast activation protein, which is frequently overexpressed in cancerous tissues. This targeted approach may improve imaging accuracy, helping doctors better identify and treat cancerous areas. Additionally, FAPI could potentially enhance the precision of non-invasive diagnostics, offering a new tool in the fight against prostate cancer.

What evidence suggests that FAPI PET/MRI is effective for diagnosing and tracking prostate cancer?

Research has shown that a new type of scan called FAPI PET holds promise for diagnosing prostate cancer. In this trial, participants will undergo FAPI PET scans, which have proven more accurate than the commonly used FDG PET scans for this purpose. This suggests that FAPI scans might be better at detecting cancer. FAPI works by attaching to a protein found in many cancer cells, making tumors easier to see. Early results indicate this could help doctors track and diagnose prostate cancer more effectively.16789

Who Is on the Research Team?

AP

Ali Pirasteh, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer. Participants will be required to undergo two PET/MRI scans, each lasting up to 2.5 hours. The eligibility criteria are not fully listed but typically include specific health conditions and demographic factors.

Inclusion Criteria

Able and willing to provide informed consent
Scheduled for standard-of-care PSMA PET
I am willing and able to have a PET/MRI for this study.
See 2 more

Exclusion Criteria

Unable or unwilling to provide informed consent
Contraindication(s) to or inability to undergo PET/MRI
Getting a PET/MRI won't delay my treatment.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo two PET/MRI scans to evaluate FAPI binding in tumor tissue

2 visits
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FAPI
Trial Overview The study is testing the use of FAPI (fibroblast activation protein inhibitor) in combination with PET/MRI scanning technology to improve diagnosis and monitoring of prostate cancer by seeing how well FAPI binds to tumor cells.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Fibroblast activation protein inhibitor (FAPI)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Published Research Related to This Trial

In a study involving 54 cancer patients, [68Ga]Ga-DOTA.SA.FAPi showed comparable effectiveness to the standard [18F]F-FDG PET/CT scans in detecting various cancers, with both tracers demonstrating similar uptake in most metastatic regions.
[68Ga]Ga-DOTA.SA.FAPi exhibited significantly higher uptake ratios in brain metastases compared to normal brain tissue, suggesting its potential for better visualization of certain cancer types, while also showing a favorable safety profile with no significant adverse effects reported.
Biodistribution, pharmacokinetics, dosimetry of [68Ga]Ga-DOTA.SA.FAPi, and the head-to-head comparison with [18F]F-FDG PET/CT in patients with various cancers.Ballal, S., Yadav, MP., Moon, ES., et al.[2021]
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.
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]
Fibroblast activation protein (FAP) imaging using quinoline-based PET tracers shows promise for identifying prostate cancer lesions that do not express the commonly used PSMA, addressing a significant clinical need.
FAP-targeting ligands not only aid in the detection of prostate cancer but may also have potential therapeutic applications, indicating a dual role in managing the disease.
Preliminary Findings of the Role of FAPi in Prostate Cancer Theranostics.Laudicella, R., Spataro, A., Crocè, L., et al.[2023]

Citations

The reproducibility of [68Ga]Ga-FAPI-04 PET uptake ...This study aimed to explore the relationship between quantitative values in [68Ga]Ga-FAPI-04 PET, specifically at 15 and 60 minutes post-injection, in patients ...
FAPI PET: Fibroblast Activation Protein Inhibitor Use ...This review provides an overview of the state of the art in FAP imaging, summarizes the current knowledge of relevant cancer biology, and ...
Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in ...68 Ga-FAPI PET demonstrated higher diagnostic accuracy than 18 F-FDG PET in the diagnosis of colorectal cancer and prostate cancer.
The reproducibility of [68Ga]Ga-FAPI-04 PET uptake ...This study aimed to explore the relationship between quantita- tive values in [68Ga]Ga-FAPI-04 PET, specifically at 15 and 60 minutes post- ...
Clinical applications of fibroblast activation protein ...This article summarizes the current state of clinical FAPI-PET imaging as well as potential uses as a theranostic agent.
[68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with ...The fibroblast activation protein α (FAP)-directed radiotracer [68Ga]Ga-FAPI-46 for PET–CT has shown promising diagnostic accuracy in cancer ...
Is There a Role for FAPI PET in Urological Cancers? - PMCFAPI PET emerges as a promising imaging modality for urological neoplasms, in particular bladder cancer. Further research is warranted to establish its role.
Clinical Explorations of [68Ga] Ga-FAPI-04 and [18F] FDG ...Recent evidence suggests that [68Ga]Ga-FAPI PET/CT imaging may predict tumor responses to therapy.11, 12, 13, 14 Additionally, FAPI PET imaging provides unique ...
Clinical Evaluation of 68 Ga-FAPI-RGD for Imaging of ...This study demonstrated the safety and clinical feasibility of 68 Ga-FAPI-RGD PET/CT for imaging of various types of cancer.
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