Metastatic prostate cancer
Conditions
Interventions
Product Name: [18F]FAPI-74
Pharmaceutical Form: Injection
Sponsors
Heikki Minn
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men with histologically confirmed prostate cancer. Age 50-85 years. WHO performance score 0-2. At least one distant metastasis detected on CT, MRI, bone scintigraphy (BS) or single-photon emission computed tomography (SPECT) imaging. All previous treatment lines are allowed. Patient signs informed consent form after receiving written information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patient is not able to understand the purpose of the study. Medical conditions prohibiting whole-body PET/CT imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: i)Evaluate the lesion-specific expression of prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP) in metastatic prostate cancer;Secondary Objective: ii)Evaluate the potential of fluorine-18 labeled FAP inhibitor (FAPI)-74 positron-emission tomography (PET)/computed tomography (CT) to detect prostate cancer metastases. iii)Evaluate the diagnostic accuracy between fluorine-18 labeled DCFPyL PSMA and FAPI-74 using PET/CT imaging iv)Evaluate the whole tracer-based metastatic load by calculating DCFPyL PSMA and FAPI-74 activated tumor volumes (TV) v)Evaluate the expression of PSMA and FAPI at the tissue level from the original tumor and metastases using immunohistochemistry. vi)Evaluate the effect of clinical characteristics (prostate-specific antigen (PSA) doubling time, type of metastases [bone/node/soft tissue], previous therapy) on the uptake of DCFPyL and FAPI-74 to the individual metastases. vii)Observe vital signs and adverse events (AE) during imaging ;Primary end point(s): i)The proportion of subject with PSMA- and/or FAPI-positive metastases and number of metastases.;Timepoint(s) of evaluation of this end point: After 18F-FAPI-74 PET/CT and 18F- DCFPyL PET/CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) The proportion of detected metastasis with 18F-FAPI-74 PET/CT compared to the 18F- DCFPyL PET/CT. ii) 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 ;Timepoint(s) of evaluation of this end point: After 18F-FAPI-74 PET/CT and 18F- DCFPyL PET/CT imaging. | — |
Countries
Finland
Contacts
Public ContactHeikki Minn
Heikki Minn
Outcome results
None listed