Prostate Cancer
Conditions
Keywords
PET, PSMA, FAP, radical prostatectomy, novel antiandrogen, enzalutamide, apalutamide, FAPi, exosome
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREComputed tomography
Positron Emission Tomography
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Exploratory prospective cohort study.
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Men scheduled for radical prostatectomy * Age over 18 years * GG 3-5, cT2-cT3, Nx, M0 prostate cancer * no contraindication to PSMA - or FAPI-PET * willing to undergo study related procedures (imaging and laboratory tests) Men scheduled for novel antiandrogen * Age over 18 years * GG2-5, cT2-4, N0-1, M1 * hormone sensitive or castration resistant prostate cancer
Exclusion criteria
* Not willing or capable to undergo study related procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value on a lesion level | through study completion, an average of 1 year | Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in wet samples | through study completion, an average of 1 year | 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 |
| Positive predictive value on a patient level | through study completion, an average of 1 year | Positive predictive value of FAPI-PET on a patient level using histopathology or confirmatory imaging as ground truth |
| To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal | through study completion, an average of 1 year | To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET |
| To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology | through study completion, an average of 1 year | 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) |
| To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry | through study completion, an average of 1 year | 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 |
Countries
Finland
Contacts
Primary ContactAntti S Rannikko, MD, PhD
Outcome results
None listed