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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05192694
Study type Interventional
Source Helsinki University Central Hospital
Contact Antti S Rannikko, MD, PhD
Phone +358405470208
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date December 15, 2022

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