The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
Time Frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Secondary Outcomes
- Correlate immunohistochemical staining with FAPI uptake measured on PET/CT(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Correlate histopathological findings after robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) to FAPI PET/CT findings to determine its diagnostic accuracy for staging of newly diagnosed PCa.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)
- Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.(within four weeks after PSMA PET/CT and within four weeks before planned treatment.)