Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000135617p
Ethics application status
Not yet submitted
Date submitted
14/12/2022
Date registered
8/02/2023
Date last updated
8/02/2023
Date data sharing statement initially provided
8/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study – Role of Fibroblast Activation Protein Inhibitor Positron Emission Tomography (FAPI PET) in patients with metastatic castrate resistant prostate cancer.
Scientific title
Pilot Study- Assessment of the usefulness of Fibroblast Activation Protein Inhibitor Positron Emission Tomography (FAPI PET) in Castrate Resistant Prostate Carcinoma patients with discordant disease at fluorodeoxyglucose Positron Emission Tomography (FDG PET)

Secondary ID [1] 308405 0
nil Known
Universal Trial Number (UTN)
Trial acronym
CONCORD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 328211 0
Condition category
Condition code
Cancer 325261 325261 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Study is a Open label , non randomized prospective pilot.

We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known metastatic prostate cancer, on the basis of current accepted diagnostic criteria.
Eligible patients will be referred by their Oncologist to our Pet CT department.
A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will undergo a PET CT scan using [68Ga]Ga-FAPI.

Eligible patients would have undergone assessment for lutetium therapy as standard care. Part of this assessment will include 2 types of PETCTs: 68Ga- PSMA and FDG.
Patients will be invited to the study must have undergone lutetium therapy suitability assessment no longer than 3 months prior to the FAPI PET.

All study activity will be carried out at Mercy Radiology, Epsom branch.

Patients will receive 1 dose of [68Ga]Ga-FAPI before their PET scan. Average radiation dose of 260MBq. The Agent will be administered intravenously under the supervision of the radiologist by a suitably trained member of staff.
So far there is no known adverse effects of FAPI serious or otherwise
The radiation exposure is considerably lower than imaging agents currently used
Patients can expect a single visit to our PETCT department.
The study visit will last approximately 2 hours
Intervention code [1] 324862 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Please note we are not evaluating or comparing FDG PET with 68Ga-PSMA PET.
We are assessing the feasibility of a larger scale trial on the usefulness of FAPI PETCT in prostrate cancer patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333107 0
Patients’ scans will be assessed following completion of FDG PET, 68Ga-PSMA PET and FAPI PET. Patients not progressing to all three scans following consent to participate will be recorded.
Timepoint [1] 333107 0
Primary endpoint will be achieved at the end of the study as cumulative data is essential to assess outcome
Primary outcome [2] 333735 0
Feasibility of a larger multicenter trial. This will include: Patient screening rate (number of screened over time); enrolment rate (number of enrolled over time); screening failure (total number of enrolled/total number of screened); reasons for screening failure, retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.
Data will be obtained through recruitment logs and patient study records
Timepoint [2] 333735 0
Primary endpoint will be achieved at the end of the study as cumulative data is essential to assess outcome
Secondary outcome [1] 415851 0
Number of patients with uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria This information will help determine if [68Ga]Ga-FAPI could be a more effective agent in detecting the extent of disease and discordant disease
Timepoint [1] 415851 0
24 hours post FAPI PETCT

Eligibility
Key inclusion criteria
Patient age >= 18 years.
• All patients diagnosed with Castrate Resistant Prostate Cancer referred for 177Lu-PSMA therapy, undergoing or having undergone assessment for discordant disease within 3 months from baseline
• Able to give informed consent
• Willing to use effective contraceptive methods for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Pts with confirmed disease who have not had [18F]FDG PET CT and 68Ga-PSMA
• Patients unable, or unwilling to consent
• Unwilling to use contraceptive methods

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2023
Actual
Date of last participant enrolment
Anticipated
9/10/2023
Actual
Date of last data collection
Anticipated
8/01/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25135 0
New Zealand
State/province [1] 25135 0

Funding & Sponsors
Funding source category [1] 312655 0
Charities/Societies/Foundations
Name [1] 312655 0
Prostate Cancer Foundation
Country [1] 312655 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Mercy Radiology
Address
Mercy Radiology
PET CT
100 Mountain Road
Epsom
1023
Country
New Zealand
Secondary sponsor category [1] 314268 0
None
Name [1] 314268 0
Address [1] 314268 0
Country [1] 314268 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311962 0
Health and Disability Ethics Committee
Ethics committee address [1] 311962 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 311962 0
New Zealand
Date submitted for ethics approval [1] 311962 0
26/02/2024
Approval date [1] 311962 0
Ethics approval number [1] 311962 0

Summary
Brief summary
Patients with patients with metastatic castrate resistant prostate cancer (MCRPC) referred for therapy with Lutetium, will undergo an assessment for discordant disease. This is usually done by asking patients to have 2 PETCT scans with different agents that we call tracers. The increased binding by the FDG tracer and absent or significantly reduced binding 68G- PSMA defines discordant disease. The finding of significant “discordant” disease may result in a recommendation not to proceed with therapy. Absent, or markedly reduced tumor binding of or 68Ga-PSMA, implies disease unlikely to respond to lutetium therapy.
Other studies show moderate tumor binding of 68Ga-FAPI in patients with MCRPC. The aim of this study is to determine FAPI’s range and patterns of tumor binding in patients with discordant disease. If we can establish if FAPI has a greater range of tumor binding than other tracers used, this will lead to a simpler method of disease staging. More importantly this may lead to the possibility of using Lu177-FAPI as a therapy for patients with discordant disease.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122982 0
Dr Andrew Henderson
Address 122982 0
Mercy Radiology
100 Mountain Road
Epsom
Auckland
1023
Country 122982 0
New Zealand
Phone 122982 0
+64 02040926652
Fax 122982 0
Email 122982 0
ahenderson@radiology.co.nz
Contact person for public queries
Name 122983 0
Mrs Rosane Joseph
Address 122983 0
Mercy Radiology
100 Mountain Road
Epsom
Auckland
1023
Country 122983 0
New Zealand
Phone 122983 0
+64 096302234
Fax 122983 0
Email 122983 0
rjoseph@radiology.co.nz
Contact person for scientific queries
Name 122984 0
Dr Andrew Henderson
Address 122984 0
Mercy Radiology
100 Mountain Road
Epsom
Auckland
1023
Country 122984 0
New Zealand
Phone 122984 0
+64 02040926652
Fax 122984 0
Email 122984 0
ahenderson@radiology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.