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

Evaluation of Fapi-pet in Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Computed tomography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antti S Rannikko, MD, PhD; Phone Number: +358405470208; Email: antti.rannikko@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Recruiting
      • Helsinki University Hospital
      • Sub-Investigator: Tuomas Mirtti, MD, PhD
      • Sub-Investigator: Henrikki Santti, MD, PhD
      • Sub-Investigator: Anssi Petas, MD, PhD
      • Sub-Investigator: Mika Matikainen, MD, PhD
      • Sub-Investigator: Tuomas Kilpeläinen, MD, PhD
      • Sub-Investigator: Antti Loimaala, MD, PhD
      • Sub-Investigator: Oleg Kerro, MD
      • Sub-Investigator: Kim Bergström, PhD
      • Sub-Investigator: Teija Koivula, PhD
      • Principal Investigator: Antti Rannikko, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FAPI PET; Prospective single arm cohort	Procedure: Computed tomography; Positron Emission Tomography; Other Names: 68-Ga-FAPI-4 PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	To explore and compare the biodistribution and signal level of FAPI-PET and PSMA-PET	through study completion, an average of 1 year
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)	through study completion, an average of 1 year
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	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	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki

Publications and helpful links

Helpful Links

• study group website

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PET; enzalutamide; PSMA; radical prostatectomy; FAP; exosome; FAPi; apalutamide; novel antiandrogen
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HUS/2997/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes