[AL[18F]F]FAPI-74 for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Men with histologically confirmed prostate cancer"}
• {"criterion_text":"- Age 50-85 years at baseline"}
• {"criterion_text":"- WHO performance score 0-2"}
• {"criterion_text":"- At least one distant metastasis detected on CT, MRI, bone scintigraphy (BS) or single-photon emission computed tomography (SPECT) imaging"}
• {"criterion_text":"- All previous treatment lines are allowed"}
• {"criterion_text":"- Patient signs informed consent form after receiving written information"}

Exclusion criteria

• {"criterion_text":"- Patient is not able to understand the purpose of the study"}
• {"criterion_text":"- Medical conditions prohibiting whole-body PET/CT imaging"}

Primary endpoints

• {"endpoint_text":"- The proportion of subject with PSMA- and/or FAPI-positive metastases and number of metastases","definition_or_measurement_approach":"Lesion-specific expression assessed by PET/CT imaging using 18F-DCFPyL and 18F-FAPI-74; outcome measured as the proportion of subjects with PSMA- and/or FAPI-positive metastases and the number of metastases per subject as detected on imaging."}

Secondary endpoints

• {"endpoint_text":"- The proportion of detected metastasis with 18F-FAPI-74 PET/CT compared to the 18F-DCFPyL PET/CT","definition_or_measurement_approach":"Comparison of detected metastases between 18F-FAPI-74 PET/CT and 18F-DCFPyL PET/CT imaging modalities."}
• {"endpoint_text":"- The sensitivity, specificity, accuracy, and area under the receiver-operating characteristic curve (AUC) values of 18F-DCFPyL PET/CT and 18F-FAPI-74 PET/CT in detecting metastatic subjects","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, accuracy, AUC) calculated for 18F-DCFPyL PET/CT and 18F-FAPI-74 PET/CT in identifying metastatic disease based on imaging comparisons."}

Finland

Earliest CTIS Part Ii Submission Date

22-01-2024

Latest Decision Or Authorization Date

28-02-2024

Processing Time Days

37

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland