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NCT Number: NCT06634173

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Metastatic Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Fluor-18-FAPI-74

Primary outcomes

  1. 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

  1. Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  2. 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.

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  3. Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  4. Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  5. Correlate immunohistochemical staining with FAPI uptake measured on PET/CT

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

Other outcomes

  1. Obtain preliminary data on the size of FAPI PET/CT-detectable pelvic lymph nodes

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  2. Correlate biopsy Gleason score to the SUVmax of primary lesions on FAPI PET/CT.

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

  3. Correlate FAPI PET/CT findings to radiological findings on biparametric MRI (radiological T stage and PI-RADS assessment category).

    Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Evelien Schouten, MSc

CONTACT

[email protected]

+3120-5129140

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Acronym: proFAPI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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