Prostate CancerFAPIPETPCANCT05192694
Evaluation of Fapi-pet in Prostate Cancer.
A study testing Computed tomography in people with Prostate Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 10 Mar 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not willing or capable to undergo study related procedures
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Antti s Rannikko, MD, PhD, antti.rannikko@hus.fi
Tuomas Mirtti, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Computed tomography
- Keywords
- PET, PSMA, FAP, radical prostatectomy, novel antiandrogen, enzalutamide, apalutamide, FAPi, exosome
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyProcedure or surgery
Also called 68-Ga-FAPI-4 PET/CT
Positron Emission Tomography
| Study group | Role | What they receive |
|---|---|---|
| FAPI PET | Other | Prospective single arm cohort Receives: Procedure: Computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start10 Mar 2022
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory prospective cohort study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Antti Rannikko, Helsinki University Central Hospital
- Investigators
- Antti S Rannikko, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192694
- Sponsor's protocol ID
- HUS/2997/2021
- Acronym
- FAPIPETPCA
- Status last verified
- Mar 2022
- First submitted
- 7 Dec 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fapi-pet in Prostate Cancer
- ClinicalTrials.gov ID
- NCT05192694
- Acronym / sponsor ID
- FAPIPETPCA / HUS/2997/2021
- Conditions
- Prostate Cancer
- Keywords
- PET, PSMA, FAP, radical prostatectomy, novel antiandrogen, enzalutamide, apalutamide, FAPi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory prospective cohort study.
| Arm | Type | Receives |
|---|---|---|
| FAPI PET | Other | Procedure: Computed tomographyProspective single arm cohort |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing or capable to undergo study related procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomographyAlso: 68-Ga-FAPI-4 PET/CTPositron Emission Tomography | Procedure or surgery | FAPI PET |
Primary outcome
Positive predictive value on a lesion level
Time frame: through study completion, an average of 1 year
Positive predictive value of FAPI-PET on a lesion level using histopathology or confirmatory imaging as ground truth
5 secondary outcomes
Positive predictive value on a patient level
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI PET signal in comparison to PSMA-PET signal
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to histology
Time frame: through study completion, an average of 1 year
To assess the biodistribution of FAPI and PSMA PET signal in comparison to immunohistochemistry
Time frame: 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
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- study group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti S Rannikko, MD, PhD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography in people with Prostate Cancer, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antti S Rannikko, MD, PhD (+358405470208, antti.rannikko@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value on a lesion level (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.