Clinical trial NCT05192694: Evaluation of Fapi-pet in Prostate Cancer.
Official title: Evaluation of Fapi-pet in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: PET
PSMA
FAP
radical prostatectomy
novel antiandrogen
enzalutamide
apalutamide
FAPi
exosome
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2022-01-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory prospective cohort study.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Positive predictive value on a lesion level
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Positive predictive value on a patient level
timeFrame: through study completion, an average of 1 year
measure: To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal
timeFrame: through study completion, an average of 1 year
measure: To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology
timeFrame: through study completion, an average of 1 year
measure: To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry
timeFrame: through study completion, an average of 1 year
measure: To assess the biodistribution of FAPI and PSMA PET signal in comparison to biomarkers in "wet" samples
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Antti S Rannikko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: