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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer. Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.

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 data supports the effectiveness of the treatment FAPI, 68Ga-FAPI, Gallium 68-labeled fibroblast activation protein inhibitor for prostate cancer?

Research shows that fibroblast activation protein (FAP) is highly expressed in certain prostate cancers, making it a promising target for imaging and potentially therapy. Studies have found that FAPI can help detect prostate cancer that doesn't show up with other imaging methods, suggesting it could be useful in managing the disease. ^{1 2 3 4 5}

Is FAPI PET/MRI safe for humans?

Studies on Gallium-68-labeled fibroblast activation protein inhibitor (68Ga-FAPI) have shown it to be a promising and safe imaging tool in various cancers, including prostate, gastrointestinal, and breast cancer, with no significant safety concerns reported in humans. ^{2 3 6 7 8}

How does FAPI PET/MRI differ from other prostate cancer treatments?

FAPI PET/MRI is unique because it uses a special tracer that targets fibroblast activation protein (FAP), which is often found in the tissue around tumors. This makes it particularly useful for imaging prostate cancer cases that do not express the usual markers, offering a new way to detect and potentially treat these cancers. ^{2 6 8 9 10}

Research Team

Ali Pirasteh, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

High fibroblast-activation-protein expression in castration-resistant prostate cancer supports the use of FAPI-molecular theranostics. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Findings of the Role of FAPi in Prostate Cancer Theranostics. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of 68 Ga-FAPI PET/CT in Breast Cancer Response Assessment and Follow-Up. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Translational imaging of the fibroblast activation protein (FAP) using the new ligand [68Ga]Ga-OncoFAP-DOTAGA. [2022]

5. Germany 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. [2023]

6. Germany 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. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

FAP imaging in rare cancer entities-first clinical experience in a broad spectrum of malignancies. [2022]

9. England 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond. [2022]