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Trial registered on ANZCTR
Registration number
ACTRN12619000791134
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
28/05/2019
Date last updated
31/03/2022
Date data sharing statement initially provided
28/05/2019
Date results information initially provided
31/03/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
A study to see whether PET scans using a chemical called Exendin can detect metastatic prostate cancer.
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Scientific title
A pilot trial of Exendin PET scanning in metastatic castrate resistant prostate cancer to demonstrate GLP1 receptor positive disease
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Secondary ID [1]
298223
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TGA Clinical Trial CT-2019-CTN-00203-1 v1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
312825
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Condition category
Condition code
Cancer
311325
311325
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Men with metastatic castrate resistant prostate cancer (mCRPC), who have disease demonstrated by PSMA (prostate specific membrane antigen) PET/CT scan will, within 2 weeks of their positive PSMA PET/CT scan, each have a single Exendin PET/CT scan to see whether the Exendin PET/CT scanning can detect mCRPC.
Details of the Exendin PET/CT scan are as follows.
Radiopharmaceutical: [68Ga]-DOTA-Exendin4.
Activity: 68Ga: 2.6 MBq/kg, maximum peptide administered 20ug/patient
Injected: Intravenously over 30 seconds via a peripheral cannula.
Patient status prior to injection: Well hydrated (orally) and not fasting, and having had baseline finger prick blood sugar confirming not hypoglycaemic and 2nd peripheral cannula in situ in case intravenous glucose is required after injection to maintain blood glucose.
Monitoring: Finger prick blood glucose measurements
Scan Acquisition: At least 60 minutes after injection and having voided prior to scanning.
Scanning location: Department of Cancer Imaging in a major cancer hospital
Scan supervision: Nuclear physician
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Intervention code [1]
314468
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
320055
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The proportion of mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning
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Assessment method [1]
320055
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Timepoint [1]
320055
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At end of each participant's Exendin PET scan
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Secondary outcome [1]
370379
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The proportion of visceral mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
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Assessment method [1]
370379
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Timepoint [1]
370379
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At end of each participant's Exendin PET scan
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Secondary outcome [2]
370380
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The proportion of nodal mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
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Assessment method [2]
370380
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Timepoint [2]
370380
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At end of each participant's Exendin PET scan
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Secondary outcome [3]
370381
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The proportion of osseous mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
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Assessment method [3]
370381
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Timepoint [3]
370381
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At end of each participant's Exendin PET scan
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Eligibility
Key inclusion criteria
1) Metastatic castrate resistant prostate cancer (mCRPC)
2) A history of radical prostatectomy
3) More than one lesion on a PSMA PET scan performed in The Department of Cancer Imaging of The Peter MacCallum Cancer Centre, Melbourne, Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Date of most recent PSMA PET scan more than 2 weeks ago
Known allergy or adverse reaction to Exenatide, other GLP-1 agonist or meta-Cresol
Creatinine clearance less than 30mL/minute and/or dialysis dependent renal failure
Type 1 diabetes
Severe gastrointestinal disease
Use of warfarin
Past history of pancreatitis
New York Heart Association Class IV dyspnoea
Intercurrent severe depression
Factors that would make it impractical to have radioactive urine
Variables that in the opinion of a member of the research team preclude the opportunity for informed consent and/or adherence to study protocol by a potential participant.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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Other reasons
Potential participants preferred to enrol in trials which offered potential therapeutic benefit and the trial had developed data supporting the hypothesis being tested.
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Date of first participant enrolment
Anticipated
30/05/2019
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Actual
28/06/2019
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Date of last participant enrolment
Anticipated
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Actual
13/08/2021
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Date of last data collection
Anticipated
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Actual
23/01/2022
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Sample size
Target
10
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
302765
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Charities/Societies/Foundations
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Name [1]
302765
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Australia and New Zealand Urological Protocols (ANZUP) Cancer Trials Group Limited
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Address [1]
302765
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Lifehouse, Level 6,
119-143 Missenden Road,
Camperdown
NSW 2050
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Country [1]
302765
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Australia
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Primary sponsor type
Other
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Name
Mark S Stein Pty Ltd
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Address
care of Dr M Stein
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
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Country
Australia
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Secondary sponsor category [1]
302703
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None
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Name [1]
302703
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Address [1]
302703
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Country [1]
302703
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303362
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
303362
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Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville Vic 3050
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Ethics committee country [1]
303362
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Australia
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Date submitted for ethics approval [1]
303362
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Approval date [1]
303362
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18/10/2018
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Ethics approval number [1]
303362
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Summary
Brief summary
Exendin PET scans are special nuclear medicine imaging scans. These scans can detect cancers whose cells have a chemical, called the GLP1 receptor, on their surfaces. However, we are unaware of any reports of the use of Exendin PET scanning in prostate cancer. The purpose of this study is to determine if prostate cancer can be detected by Exendin PET scans.
Who is it for?
You may only be eligible for this study if you have metastatic castrate-resistant prostate cancer and have already been identified as potentially suitable for the study by our research team.
Study details
The study will assess whether PET scans using the chemical called Exendin can detect metastatic prostate cancer. Participants will have had a PET scan using the chemical PSMA (which is the usual type of PET scan used to detect prostate cancer) within the preceding 2 weeks. They will then have a single Exendin PET/CT scan at a major hospital. The procedure will involve:
a) Injecting the study chemical (called [68Ga]-DOTA-Exendin) into an arm vein.
b) Finger prick glucose testing to confirm participant blood sugar levels.
c) An Exendin PET scan 60 minutes after the chemical injection.
We hope this will demonstrate that prostate cancers can be detected by Exendin PET scans. If we can demonstrate that, we will have confirmed that prostate cancers bear GLP1 receptor.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mark Stein
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Address
93406
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care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
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Country
93406
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Australia
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Phone
93406
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Telephone +61 3 9210 7000
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Fax
93406
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Email
93406
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[email protected]
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Contact person for public queries
Name
93407
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Dr Mark Stein
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Address
93407
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care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
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Country
93407
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Australia
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Phone
93407
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Telephone +61 3 9210 7000
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Fax
93407
0
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Email
93407
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[email protected]
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Contact person for scientific queries
Name
93408
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Dr Mark Stein
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Address
93408
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care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
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Country
93408
0
Australia
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Phone
93408
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Telephone +61 3 9210 7000
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Fax
93408
0
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Email
93408
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No ethics approval for this and participants are not providing consent for this
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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.
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