The investigators explore the biodistribution of FAPI-PET expression in primary high-risk prostate cancer in men undergoing RALP and eLND and in men with metastatic PCa about to start next generation antiandrogen.
This is an exploratory cohort study comprised of men with clinically localized or locally advanced high-risk prostate cancer (GG 3-5, cT2-cT3, Nx, M0) managed by RALP and eLND and men with metastatic (mHSPC or mCRPC) prostate cancer scheduled to start NHT along clinical care pathway (e.g., apalutamide, enzalutamide) at HUS Helsinki University Hospital and Helsinki University, Finland. Men identified along routine clinical care as candidates for the study will be asked to consent. Once consented, patients will undergo PSMA-PET imaging instead of conventional imaging (CT and bone scan) and experimental FAPI-PET imaging. Furthermore, biomarker samples will be obtained before and after treatment (surgery or novel antiandrogen) and surgical specimen will be processed for routine pathological evaluation and multiplex IHC studies. Serum samples will be tested for PCa biomarkers (e.g., PSA, NSE, CgA) and cfDNA. Urine will be processed and extracellular vesicles (exosomes) isolated and markers of reactive stroma will be sought for. Radical prostatectomy and novel hormonal treatment will be done according to current recommendations and guidelines in Finland. Postoperatively, patients will be followed with PSA every six months. Biochemical recurrence will be set at PSA of 0.2 ug/l or higher.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
Positron Emission Tomography
Helsinki University Hospital
Helsinki, Uusimaa, Finland
RECRUITINGPositive predictive value on a lesion level
Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth
Time frame: through study completion, an average of 1 year
Positive predictive value on a patient level
Positive predictive value of FAPI-PET on a patient level using histopathology or confirmatory imaging as ground truth
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal
To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology
To explore the biodistribution and signal level of FAP-PET and PSMA-PET in correlation to reference histology (lesion volume and grade in radical prostatectomy specimen and lymphadenectomy specimen)
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry
To explore the biodistribution and signal level of FAPI-PET and PSMA-PET in correlation to tissue protein levels of: 1. FAP and PSMA 2. Markers of reactive stroma and CAFs 3. Neuregulin-1 4. Androgen receptor signalling pathway
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples
To correlate FAPI-PET and PSMA-PET biodistribution and signal level to: 1. Postoperative serum biomarker levels (e.g., PSA, afos) 2. cfDNA/RNA levels in peripheral blood 3. Urinary exosome status for markers of reactive stroma 4. Biochemical recurrence
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Time frame: through study completion, an average of 1 year