Prostate CancerproFAPINCT06634173
The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer
A study testing FAPI PET/CT in people with Prostate Cancer and Prostate Cancer Metastatic, run by The Netherlands Cancer Institute.
Trial summary
This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- FAPI PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged ≥ 18 years;
- WHO performance status 0, 1 or 2;
- Written informed consent;
- Biopsy-proven newly diagnosed PCa;
- International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.
- If all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria:
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- Group 1 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases.
- Group 2 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases;
- Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) [22];
- Scheduled for (laparoscopic) prostatectomy including ePLND.
Who cannot join
- Known second malignant disease that may complicate image interpretation.
- Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. If available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- FAPI PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CTDiagnostic test
Also called Fluor-18-FAPI-74
This study applies the radiopharmaceutical 18Fluor-FAPI-74 (FAPI) for molecular imaging of FAP expression in vivo with FAPI PET/CT, to assess the presence and distribution of activated Cancer associated fibroblasts as a marker of Tumor Micro-Environment and indirectly as a marker for malignancies.
| Study group | Role | What they receive |
|---|---|---|
| FAPI PET/CT | Experimental | Patients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment. Receives: Diagnostic Test: FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Secondary outcomes (5)
Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate histopathological findings after robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) to FAPI PET/CT findings to determine its diagnostic accuracy for staging of newly diagnosed PCa.
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate immunohistochemical staining with FAPI uptake measured on PET/CT
Measured: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (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 The Netherlands Cancer InstituteThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an interventional study without concurrent controls.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634173
- Sponsor's protocol ID
- M22PFI
- Acronym
- proFAPI
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT06634173
- Acronym / sponsor ID
- proFAPI / M22PFI
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Oct 2024 (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.
This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. If available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an interventional study without concurrent controls.
| Arm | Type | Receives |
|---|---|---|
| FAPI PET/CT | Experimental | Diagnostic Test: FAPI PET/CTPatients will undergo an additional diagnostic FAPI PET/CT scan within four weeks after PSMA PET/CT and within four weeks before planned treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male, aged ≥ 18 years;
- WHO performance status 0, 1 or 2;
- Written informed consent;
- Biopsy-proven newly diagnosed PCa;
- International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.
Key exclusion criteria (2 listed)
- Known second malignant disease that may complicate image interpretation.
- Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
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 |
|---|---|---|
| FAPI PET/CTAlso: Fluor-18-FAPI-74This study applies the radiopharmaceutical 18Fluor-FAPI-74 (FAPI) for molecular imaging of FAP expression in vivo with FAPI PET/CT, to assess the presence and distribution of activated Cancer associated fibroblasts as a marker of Tumor Micro-Environment and indirectly as a marker for malignancies. | Diagnostic test | FAPI PET/CT |
Primary outcome
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa.
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
5 secondary outcomes
Diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging of newly diagnosed PCa
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate histopathological findings after robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND) to FAPI PET/CT findings to determine its diagnostic accuracy for staging of newly diagnosed PCa.
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate laboratory parameters (prostate specific antigen (PSA) levels) after treatment to FAPI PET/CT findings to determine its diagnostic accuracy.
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Obtain preliminary data on the FAP overexpression in primary prostate tumor and lymph node metastases by immunohistochemical staining.
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Correlate immunohistochemical staining with FAPI uptake measured on PET/CT
Time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET/CT in people with Prostate Cancer and Prostate Cancer Metastatic, run by The Netherlands Cancer Institute.
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 12 inclusion and 2 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Evelien Schouten, MSc (+3120-5129140, ev.schouten@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rates and target-to-background ratios of FAPI PET/CT in patients with hormone-sensitive PCa. (time frame: within four weeks after PSMA PET/CT and within four weeks before planned treatment.). 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 9 Oct 2024.