The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer Prostate Cancer Metastatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an interventional study without concurrent controls.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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FAPI PET/CT

Patients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment.

Group Type EXPERIMENTAL

FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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FAPI PET/CT

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fluor-18-FAPI-74

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No