Back to results

Evaluation of Fapi-pet in Prostate Cancer. (FAPIPETPCA)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Computed tomography

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring PET, PSMA, FAP, radical prostatectomy, novel antiandrogen, enzalutamide, apalutamide, FAPi, exosome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FAPI PET

Arm Description

Prospective single arm cohort

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal

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

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

To explore the biodistribution and signal level of FAPI-PET and PSMA-PET in correlation to tissue protein levels of: FAP and PSMA Markers of reactive stroma and CAFs Neuregulin-1 Androgen receptor signalling pathway

To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples

To correlate FAPI-PET and PSMA-PET biodistribution and signal level to: Postoperative serum biomarker levels (e.g., PSA, afos) cfDNA/RNA levels in peripheral blood Urinary exosome status for markers of reactive stroma Biochemical recurrence

Full Information

NCT ID

NCT05192694

First Posted

December 7, 2021

Last Updated

March 10, 2022

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT05192694

Brief Title

Evaluation of Fapi-pet in Prostate Cancer.

Acronym

FAPIPETPCA

Official Title

Evaluation of Fapi-pet in Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

December 15, 2022 (Anticipated)

Study Completion Date

December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

PET, PSMA, FAP, radical prostatectomy, novel antiandrogen, enzalutamide, apalutamide, FAPi, exosome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Exploratory prospective cohort study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FAPI PET

Arm Type

Other

Arm Description

Prospective single arm cohort

Intervention Type

Procedure

Intervention Name(s)

Computed tomography

Other Intervention Name(s)

68-Ga-FAPI-4 PET/CT

Intervention Description

Positron Emission Tomography

Primary Outcome Measure Information:

Title

Positive predictive value on a lesion level

Description

Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Positive predictive value on a patient level

Description

Positive predictive value of FAPI-PET on a patient level using histopathology or confirmatory imaging as ground truth

Time Frame

through study completion, an average of 1 year

Title

To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal

Description

To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET

Time Frame

through study completion, an average of 1 year

Title

To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology

Description

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)

Time Frame

through study completion, an average of 1 year

Title

To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry

Description

Time Frame

through study completion, an average of 1 year

Title

To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples

Description

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antti S Rannikko, MD, PhD

Phone

+358405470208

antti.rannikko@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antti S Rannikko, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antti s Rannikko, MD, PhD

antti.rannikko@hus.fi

First Name & Middle Initial & Last Name & Degree

Tuomas Mirtti, MD, PhD

First Name & Middle Initial & Last Name & Degree

Henrikki Santti, MD, PhD

First Name & Middle Initial & Last Name & Degree

Anssi Petas, MD, PhD

First Name & Middle Initial & Last Name & Degree

Mika Matikainen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Tuomas Kilpeläinen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Teijo Pellinen, PhD

First Name & Middle Initial & Last Name & Degree

Antti Loimaala, MD, PhD

First Name & Middle Initial & Last Name & Degree

Oleg Kerro, MD

First Name & Middle Initial & Last Name & Degree

Kim Bergström, PhD

First Name & Middle Initial & Last Name & Degree

Teija Koivula, PhD

First Name & Middle Initial & Last Name & Degree

Antti Rannikko, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study protocol

IPD Sharing Time Frame

during the study

IPD Sharing Access Criteria

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

IPD Sharing URL

http://hucc.fi

Links:

URL

http://www.hucc.fi

Description

study group website

Learn more about this trial

Evaluation of Fapi-pet in Prostate Cancer.

We'll reach out to this number within 24 hrs