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

Launched by THE NETHERLANDS CANCER INSTITUTE · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new imaging technique called FAPI PET/CT to see how well it can stage newly diagnosed prostate cancer compared to the standard method, PSMA PET/CT. The goal is to find out which method detects cancer more accurately and helps doctors understand the extent of the disease. The researchers will also compare the results of these imaging tests with actual tissue samples from patients who undergo surgery to check how accurate the tests are.

To participate in this study, you need to be a male aged 18 or older, diagnosed with prostate cancer confirmed by a biopsy, and have a certain level of cancer severity based on specific medical criteria. Participants will undergo both imaging tests, and if you qualify, you may have the chance to contribute to important research that could improve cancer staging methods in the future. This trial is not recruiting yet, but it's an exciting opportunity for those who meet the eligibility criteria to help advance our understanding of prostate cancer diagnosis.

Gender

MALE

Eligibility criteria

• 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.