FAPI PET/MRI for Prostate Cancer

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Disqualifiers: Sedation, Consent issues, MRI contraindications, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

Group I: Fibroblast activation protein inhibitor (FAPI) Experimental Treatment 3 Interventions

FAPI radiotracer will be used during PET

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Role of FAPi in Prostate Cancer Theranostics. Laudicella, R., Spataro, A., Crocè, L., et al.[2023]

In a study involving 19 patients with head and neck and gastrointestinal cancers, dual-tracer PET/CT using [18F]FDG and [68Ga]Ga-FAPI-46 provided better visualization of tumors, showing higher target-to-background ratios (TBRs) and larger functional tumor volumes (FTV) compared to single-tracer PET/CT.

The dual-tracer approach was superior in detecting malignant tissue in 6 out of 19 patients, indicating that [68Ga]Ga-FAPI-46 enhances the diagnostic performance and staging of cancer, making it a valuable tool in pretherapeutic assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-tracer PET/CT protocol with [18F]FDG and [68Ga]Ga-FAPI-46 outperforms single-tracer PET/CT with [18F]FDG in different cancer types, resulting in larger functional and gross tumor volume. Wegen, S., Weindler, J., Voltin, CA., et al.[2023]

The study involved 6 patients with invasive lobular breast cancer who underwent 24 scans, showing that the 68 Ga-FAPI PET/CT radiotracer effectively correlates tumor volume with blood biomarkers, indicating its potential for monitoring cancer progression and treatment response.

While 68 Ga-FAPI showed a strong correlation with blood biomarkers (r = 0.7, P < 0.01), it had a weaker correlation with traditional CT imaging, suggesting that FAPI may provide additional insights into tumor behavior that standard imaging might miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of 68 Ga-FAPI PET/CT in Breast Cancer Response Assessment and Follow-Up. Eshet, Y., Tau, N., Levanon, K., et al.[2023]

68Ga-FAPI-04 is an effective PET imaging agent that can help diagnose conditions like IgG4-related disease (IgG4-RD) by targeting fibroblast activation protein, which is often present in tumors and inflammatory tissues.

In a case study of a 62-year-old patient, 68Ga-FAPI PET provided clearer diagnostic information than traditional 18F-FDG PET, highlighting its potential to differentiate between pancreatitis and pancreatic cancer when other imaging results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-FAPI-04 PET/MR is helpful in differential diagnosis of pancreatitis from pancreatic malignancy compared to 18F-FDG PET/CT: a case report. Shou, Y., Xue, Q., Yuan, J., et al.[2021]

In a study involving 94 prostate cancer patients at various stages, fibroblast-activation-protein (FAP) expression significantly increased with disease progression, indicating its potential as a biomarker for advanced prostate cancer.

The use of [68 Ga]Ga-FAPI-04 PET/CT imaging showed high positivity in patients with advanced castration-resistant prostate cancer (CRPC), supporting the utility of FAP-targeted therapies in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High fibroblast-activation-protein expression in castration-resistant prostate cancer supports the use of FAPI-molecular theranostics. Kesch, C., Yirga, L., Dendl, K., et al.[2022]

In a study of 129 patients, 68Ga-FAPI PET scans identified elevated uptake in bones and joints in 63.57% of cases, revealing 295 lesions, with 31.9% being malignant (all metastases) and 68.1% benign, including conditions like arthritis and periodontitis.

68Ga-FAPI PET was more effective than 18F-FDG PET in detecting lesions, identifying 104 lesions compared to 48, and while it showed higher uptake in bone metastases, this difference does not reliably distinguish between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond. Qin, C., Song, Y., Liu, X., et al.[2022]

In a study of 55 patients with rare cancers, 68Ga-FAPI-PET/CT imaging successfully identified primary tumors in 20 patients and detected metastases in 31 patients, demonstrating high tracer uptake in both primary and metastatic lesions, particularly in liver and peritoneal cancers.

The imaging technique showed excellent tumor visualization with high tumor-to-background ratios (TBR), indicating its potential as a valuable tool for diagnosing and staging rare malignancies, especially epithelial carcinomas, warranting further prospective studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FAP imaging in rare cancer entities-first clinical experience in a broad spectrum of malignancies. Dendl, K., Finck, R., Giesel, FL., et al.[2022]

The novel radiolabeled compound 68Ga-OncoFAP shows high affinity for fibroblast activation protein (FAP) and demonstrates excellent properties for PET imaging, including high tumor uptake and favorable biodistribution in both preclinical and clinical settings.

In a study involving 12 patients, 68Ga-OncoFAP exhibited significant uptake in various cancers, with maximum standardized uptake values (SUVmax) indicating its potential as a powerful alternative to existing FAP tracers for cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational imaging of the fibroblast activation protein (FAP) using the new ligand [68Ga]Ga-OncoFAP-DOTAGA. Backhaus, P., Gierse, F., Burg, MC., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12089092/

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 ...

2.

pubs.rsna.org

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

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 ...

3.

jnm.snmjournals.org

jnm.snmjournals.org/content/65/3/372

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.

4.

e-century.us

e-century.us/files/ajnmmi/15/2/ajnmmi0162535.pdf

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- ...

5.

nature.com

nature.com/articles/s44303-024-00053-z

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.

6.

thelancet.com

thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00299-2/fulltext

[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 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11512897/

Is There a Role for FAPI PET in Urological Cancers? - PMC

FAPI PET emerges as a promising imaging modality for urological neoplasms, in particular bladder cancer. Further research is warranted to establish its role.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0001299824000850

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 ...

9.

jnm.snmjournals.org

jnm.snmjournals.org/content/64/8/1210

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.