Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-03-10
2022-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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FAPI PET
Prospective single arm cohort
Computed tomography
Positron Emission Tomography
Interventions
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Computed tomography
Positron Emission Tomography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
MALE
No
Sponsors
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University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Antti Rannikko
Assistant professor
Principal Investigators
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Antti S Rannikko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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Helsinki University Hospital
Helsinki, Uusimaa, Finland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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study group website
Other Identifiers
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HUS/2997/2021
Identifier Type: -
Identifier Source: org_study_id
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