Evaluation of Fapi-pet in Prostate Cancer. | NCT05192694

Studies
Evaluation of Fapi-pet in Prostate Cancer.

NCT05192694

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Computed tomography

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Dec 15, 2022Estimated

Completion Date

Dec 15, 2022Estimated

First Submitted Date

Dec 7, 2021

First Submission Date that Met QC Criteria

Jan 13, 2022

First Posted Date

Jan 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2022

Last Update Posted Date

Mar 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antti Rannikko, Assistant professor, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
University of Helsinki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FAPI PET	Other	Prospective single arm cohort	Procedure: Computed tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computed tomography	Procedure	Positron Emission Tomography	FAPI PET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	through study completion, an average of 1 year
To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antti S Rannikko, MD, PhD	Contact	+358405470208		antti.rannikko@hus.fi

Overall Officials

Name	Affiliation	Role
Antti S Rannikko, MD, PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital	Recruiting	Helsinki	Uusimaa	00029	Finland

Label	URL
study group website	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol

Types

Study Protocol

Time Frame

during the study

Access Criteria

publically available at the study group web site once study starts.

URL

http://hucc.fi

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided