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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAPI PET/CT | Experimental | Patients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAPI PET/CT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa. | within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain preliminary data on the size of FAPI PET/CT-detectable pelvic lymph nodes | within four weeks after PSMA PET/CT and within four weeks before planned treatment. | |
| Correlate biopsy Gleason score to the SUVmax of primary lesions on FAPI PET/CT. | within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
Inclusion Criteria:
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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelien Schouten, MSc | Contact | +3120-5129140 | ev.schouten@nki.nl |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is an interventional study without concurrent controls.
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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.
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| 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. |
| Correlate immunohistochemical staining with FAPI uptake measured on PET/CT | within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
| Correlate FAPI PET/CT findings to radiological findings on biparametric MRI (radiological T stage and PI-RADS assessment category). | within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |