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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
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.
Scientific title
A pilot trial of Exendin PET scanning in metastatic castrate resistant prostate cancer to demonstrate GLP1 receptor positive disease
Secondary ID [1] 298223 0
TGA Clinical Trial CT-2019-CTN-00203-1 v1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 312825 0
Condition category
Condition code
Cancer 311325 311325 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 314468 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320055 0
The proportion of mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning
Timepoint [1] 320055 0
At end of each participant's Exendin PET scan
Secondary outcome [1] 370379 0
The proportion of visceral mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
Timepoint [1] 370379 0
At end of each participant's Exendin PET scan
Secondary outcome [2] 370380 0
The proportion of nodal mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
Timepoint [2] 370380 0
At end of each participant's Exendin PET scan
Secondary outcome [3] 370381 0
The proportion of osseous mCRPC lesions detected by PSMA PET scanning which are also detected by Exendin PET scanning.
Timepoint [3] 370381 0
At end of each participant's Exendin PET scan

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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.
Date of first participant enrolment
Anticipated
30/05/2019
Actual
28/06/2019
Date of last participant enrolment
Anticipated
Actual
13/08/2021
Date of last data collection
Anticipated
Actual
23/01/2022
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302765 0
Charities/Societies/Foundations
Name [1] 302765 0
Australia and New Zealand Urological Protocols (ANZUP) Cancer Trials Group Limited
Country [1] 302765 0
Australia
Primary sponsor type
Other
Name
Mark S Stein Pty Ltd
Address
care of Dr M Stein
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
Country
Australia
Secondary sponsor category [1] 302703 0
None
Name [1] 302703 0
Address [1] 302703 0
Country [1] 302703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303362 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303362 0
Ethics committee country [1] 303362 0
Australia
Date submitted for ethics approval [1] 303362 0
Approval date [1] 303362 0
18/10/2018
Ethics approval number [1] 303362 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93406 0
Dr Mark Stein
Address 93406 0
care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
Country 93406 0
Australia
Phone 93406 0
Telephone +61 3 9210 7000
Fax 93406 0
Email 93406 0
[email protected]
Contact person for public queries
Name 93407 0
Mark Stein
Address 93407 0
care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
Country 93407 0
Australia
Phone 93407 0
Telephone +61 3 9210 7000
Fax 93407 0
Email 93407 0
[email protected]
Contact person for scientific queries
Name 93408 0
Mark Stein
Address 93408 0
care of
Knox Private Hospital
262 Mountain Highway
Wantirna
Victoria 3152
Country 93408 0
Australia
Phone 93408 0
Telephone +61 3 9210 7000
Fax 93408 0
Email 93408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethics approval for this and participants are not providing consent for this


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.