Evaluation of Fapi-pet in Prostate Cancer.
FAPIPETPCA
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Mar 2022
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedMarch 11, 2022
March 1, 2022
9 months
December 7, 2021
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive predictive value on a lesion level
Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth
through study completion, an average of 1 year
Secondary Outcomes (5)
Positive predictive value on a patient level
through study completion, an average of 1 year
To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal
through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology
through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry
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
through study completion, an average of 1 year
Study Arms (1)
FAPI PET
OTHERProspective single arm cohort
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not willing or capable to undergo study related procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- University of Helsinkicollaborator
Study Sites (1)
Helsinki University Hospital
Helsinki, Uusimaa, 00029, Finland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antti S Rannikko, MD, PhD
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 7, 2021
First Posted
January 14, 2022
Study Start
March 10, 2022
Primary Completion
December 15, 2022
Study Completion
December 15, 2022
Last Updated
March 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- during the study
- Access Criteria
- publically available at the study group web site once study starts.
Study protocol