Metastatic Malignant Neoplasm in the Prostate GlandPhase 1FAPI PET ProstNCT04457232
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
A Phase 1 study testing Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography in people with Metastatic Malignant Neoplasm in the Prostate Gland and Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma
- What is being tested?
- Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, 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
- 9 Sep 2020to 30 May 2027
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment
- Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
- Patients can provide written informed consent
- Patients are able to remain still for duration of imaging procedure (up to one hour)
Who cannot join
- Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.
SECONDARY OBJECTIVES:
- To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.
- Conditions
- Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma
- Being tested
- Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo PET/CT imaging
Gallium Ga 68 FAPi-46Other
Also called 68Ga-FAPi-46, Gallium-68-FAPi-46
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Basic Science (68Ga-FAPi-46 PET/CT) | Experimental | Patients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes. Receives: Procedure: Computed Tomography; Other: Gallium Ga 68 FAPi-46; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV], SUVmean and SUVmax.
Measured: 60 minutes after tracer injection
Secondary outcomes (2)
To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue
68Ga-FAPi-46 tumor SUVs will be correlated with FAP expression from surgically resected tumors. IHC will be scored with a semi-quantitative scoring system that accounts for staining intensity (0-2, where 0 is negative, 1 is weak, 2 is strong and eq. stands for equivocal). Correlations will be sought using least square regression analysis.
Measured: Up to date of surgery (range 1-60 days)
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax) and tested for correlation.
Measured: 60 minutes after tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start9 Sep 2020
- Primary completion30 May 2023
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the Prostate GlandStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Jeremie Calais, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457232
- Sponsor's protocol ID
- 20-000177
- Other IDs
- NCI-2020-02712, 20-000177
- Acronym
- FAPI PET Prost
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
- ClinicalTrials.gov ID
- NCT04457232
- Acronym / sponsor ID
- FAPI PET Prost / 20-000177
- Conditions
- Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma, Recurrent Prostate Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 7 Jul 2020 (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.
This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.
Detailed description
PRIMARY OBJECTIVE:
- To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.
SECONDARY OBJECTIVES:
- To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.
II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.
OUTLINE:
Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic Science (68Ga-FAPi-46 PET/CT) | Experimental | Procedure: Computed Tomography, Other: Gallium Ga 68 FAPi-46, Procedure: Positron Emission TomographyPatients receive 68Ga-FAPi-46 IV and undergo PET/CT imaging over 20-50 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment
- Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
- Patients can provide written informed consent
- Patients are able to remain still for duration of imaging procedure (up to one hour)
Key exclusion criteria (1 listed)
- Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo PET/CT imaging | Procedure or surgery | Basic Science (68Ga-FAPi-46 PET/CT) |
| Gallium Ga 68 FAPi-46Also: 68Ga-FAPi-46, Gallium-68-FAPi-46Given IV | Other | Basic Science (68Ga-FAPi-46 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT imaging | Procedure or surgery | Basic Science (68Ga-FAPi-46 PET/CT) |
Primary outcome
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer
Time frame: 60 minutes after tracer injection
To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values [SUV], SUVmean and SUVmax.
2 secondary outcomes
To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of fibroblast activation protein (FAP) assessed by immunohistochemistry (IHC) in excised cancer tissue
Time frame: Up to date of surgery (range 1-60 days)
To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11 PET imaging
Time frame: 60 minutes after tracer injection
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 20 Aug 2026.
Related trials for Metastatic Malignant Neoplasm in the Prostate Gland
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Active, not recruitingPhase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
Advanced or Metastatic Solid Tumors
Active, not recruitingPhase 1/2
Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies
Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma
RecruitingObservational study
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer
Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone
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. This study is not recruiting at the moment.
Jeremie Calais principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography, Gallium Ga 68 FAPi-46 and Positron Emission Tomography in people with Metastatic Malignant Neoplasm in the Prostate Gland and Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define and document the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer (time frame: 60 minutes after tracer injection). 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 20 Aug 2026.