Evaluation of Fapi-pet in Prostate Cancer.

Prostate Cancer Clinical Trial

— FAPIPETPCA  

Official title:

Evaluation of Fapi-pet in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192694
• Other study ID #: HUS/2997/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2022
• Source: Helsinki University Central Hospital
• Contact: Antti S Rannikko, MD, PhD
• Phone: +358405470208
• Email: antti.rannikko[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Computed tomography
Positron Emission Tomography

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki	Uusimaa

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   study group website