Clinical trial · Interventional
Using FAPI PET/MRI to Evaluate Prostate Cancer
Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
NCT06675357CI-TRIAL-00114196recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic Disease | — | UNRESOLVED | — |
| Prostate Cancers | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI | Radiation | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography (PET) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fibroblast activation protein inhibitor (FAPI)
- description
- FAPI radiotracer will be used during PET
- interventionNames
- Radiation: FAPI
- Procedure: Positron Emission Tomography (PET)
- Procedure: Magnetic Resonance Imaging
Primary outcomes (3)
- measure
- Performance of FAPI for lesion detection
- timeFrame
- Duration of scan, up to 80 minutes
- description
- Sensitivity and specificity for lesion detection on FAPI will be compared with that of PSMA PET, using a composite reference standard (all available histology, follow up clinical/standard of care imaging, serum PSA).
- measure
- Lesion FAPI uptake on PET
- timeFrame
- Duration of scan, up to 80 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Able and willing to provide informed consent * Known diagnosis of prostate cancer * Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET * Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases. * Willing and able to undergo PET/MRI as part of this research Exclusion Criteria: * Unable or unwilling to provide informed consent * Contraindication(s) to or inability to undergo PET/MRI * Participants for whom PET/MRI will delay timely delivery of treatment * Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met: * Have their own prescription for the medication * The informed consent process is conducted prior to the self-administration of this medication * Come to the research visit with a driver
References
Publications (0)
Data not yet available
No reference posted for this study.