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Trial Title:
The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer
NCT ID:
NCT06634173
Condition:
Prostate Cancer
Prostate Cancer Metastatic
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is an interventional study without concurrent controls.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
All scans will be reviewed by two senior nuclear medicine physicians (NWZ-Alkmaar and/or
NCI-AVL), separately and blinded to any clinical information. If a consensus is not
reached, a third observer is included.
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
FAPI PET/CT
Description:
This study applies the radiopharmaceutical 18Fluor-FAPI-74 (FAPI) for molecular imaging
of FAP expression in vivo with FAPI PET/CT, to assess the presence and distribution of
activated Cancer associated fibroblasts as a marker of Tumor Micro-Environment and
indirectly as a marker for malignancies.
Arm group label:
FAPI PET/CT
Other name:
Fluor-18-FAPI-74
Summary:
This study aims to investigate the diagnostic value of FAPI PET/CT, relative to
standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI
PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in
detection rates and target-to-background ratios. If available, histopathology of resected
specimens will serve as reference test for operated patients in order to determine
diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential
subsequent larger prospective diagnostic study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male, aged ≥ 18 years;
- WHO performance status 0, 1 or 2;
- Written informed consent;
- Biopsy-proven newly diagnosed PCa;
- International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA
≥ 20 ng/ml and/or ≥cT3a.
If all of the criteria above are met, a subject must also meet all of the following
subgroup specific criteria:
Group 1 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant
metastases.
Group 2 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant
metastases;
- Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti
≥40%) [22];
- Scheduled for (laparoscopic) prostatectomy including ePLND.
Exclusion Criteria:
- Known second malignant disease that may complicate image interpretation.
- Inability to cooperate with the scan process: inability to lie relatively still and
in supine for 30-60 minutes or patient body habitus above scanner dimensions.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06634173
