NCT04457232Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Prostate Cancer: A Prospective Exploratory Biodistribution Study With Histopathology Validation
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 30 Jun 2020
- Start date
- 9 Sept 2020
- Primary completion date
- 30 May 2023
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT04457232
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 9 Sept 2020 to the primary completion date, 30 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.