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

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: Computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05192694

HUS/2997/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

FAPI PET

Other group

Description:

Prospective single arm cohort

Treatment:

Procedure: Computed tomography