Prostate Cancer Metastatic DiseasePhase 2NCT06675357
Using FAPI PET/MRI to Evaluate Prostate Cancer
A Phase 2 study testing FAPI, Positron Emission Tomography (PET) and Magnetic Resonance Imaging in people with Prostate Cancer Metastatic Disease and Prostate Cancers, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer Metastatic Disease, Prostate Cancers
- What is being tested?
- FAPI, Positron Emission Tomography (PET) and Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Ali Pirasteh, MD
Joshua Lang, PhD
About this study
Official title: Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
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.
- Being tested
- FAPI, Positron Emission Tomography (PET), Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPIRadiation
5 +/- 2 mCi of Ga-FAPI-46
Positron Emission Tomography (PET)Procedure or surgery
Undergo PET scan
Magnetic Resonance ImagingProcedure or surgery
Undergo MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Fibroblast activation protein inhibitor (FAPI) | Experimental | FAPI radiotracer will be used during PET Receives: Radiation: FAPI; Procedure: Positron Emission Tomography (PET); Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of FAPI for lesion detection
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).
Measured: Duration of scan, up to 80 minutes
Lesion FAPI uptake on PET
FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.
Measured: Duration of scan, up to 80 minutes
Total FAPI-positive tumor volume change
The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.
Measured: Duration of scan, up to 80 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start27 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Pirasteh, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675357
- Sponsor's protocol ID
- 2024-0747
- Other IDs
- A539300, Protocol Version 8/4/25, UW24045, Prostate SPORE
- Status last verified
- Jun 2026
- First submitted
- 4 Nov 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel FAP-targeted Approach to Imaging Patients With or High-risk for Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06675357
- Acronym / sponsor ID
- 2024-0747
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroblast activation protein inhibitor (FAPI) | Experimental | Radiation: FAPI, Procedure: Positron Emission Tomography (PET), Procedure: Magnetic Resonance ImagingFAPI radiotracer will be used during PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI5 +/- 2 mCi of Ga-FAPI-46 | Radiation | Fibroblast activation protein inhibitor (FAPI) |
| Positron Emission Tomography (PET)Undergo PET scan | Procedure or surgery | Fibroblast activation protein inhibitor (FAPI) |
| Magnetic Resonance ImagingUndergo MRI scan | Procedure or surgery | Fibroblast activation protein inhibitor (FAPI) |
Primary outcome
Performance of FAPI for lesion detection
Time frame: Duration of scan, up to 80 minutes
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).
Lesion FAPI uptake on PET
Time frame: Duration of scan, up to 80 minutes
FAPI uptake as measured by SUV will be correlated against tissue FAP positivity on immunohistochemistry and FAP expression on qPCR, using linear regression.
Total FAPI-positive tumor volume change
Time frame: Duration of scan, up to 80 minutes
The total FAPI-positive tumor volume between pre- and post-treatment exams will be measured and compared to PSMA-response, other standard-of-care imaging response, and overall survival when available, using odds ratios for treatment response and Kaplan-Meier curve for survival.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data with GE Healthcare: images, diagnosis, image quality scores, quantitative PET/MR measurements, BMI, weight, height, age and gender. The Department of Radiology Medical Imaging Research Support (MIRS) Radius team will serve as an honest broker for the sharing of de-identified data.
Related trials for Prostate Cancer Metastatic Disease
RecruitingPhase 2/3
Safety and Efficacy of OTL78
Prostate Cancer Surgery, Prostate Cancer Metastatic Disease
RecruitingPhase 1
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients
Active, not recruitingPhase 2
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Metastatic Prostate Cancer, Prostatic Neoplasms
RecruitingPhase 2
Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer
Metastatic Prostate Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Pirasteh, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAPI, Positron Emission Tomography (PET) and Magnetic Resonance Imaging in people with Prostate Cancer Metastatic Disease and Prostate Cancers, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radiology Studies (608-282-8349, Radstudy@uwhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of FAPI for lesion detection (time frame: Duration of scan, up to 80 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.