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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa. [Срок оценки: within four weeks after PSMA PET/CT and within four weeks before planned treatment.]

Вторичные конечные точки (5)

• Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: within four weeks after PSMA PET/CT and within four weeks before planned treatment.]
• Correlate immunohistochemical staining with FAPI uptake measured on PET/CT [Срок оценки: within four weeks after PSMA PET/CT and within four weeks before planned treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06634173 · M22PFI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗