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Trial registered on ANZCTR


Registration number
ACTRN12615001324505
Ethics application status
Approved
Date submitted
30/11/2015
Date registered
3/12/2015
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 0 Trial of Gallium-68 tris-hydroxypyridinone prostate specific membrane antigen (Ga-68 THP-PSMA) positron emission tomography (PET) scanning for prostate cancer
Scientific title
In patients with prostate cancer, what is the uptake in tumours and normal tissue on positron emission tomography (PET) following administration of Ga-68 THP-PSMA?
Secondary ID [1] 288040 0
None
Universal Trial Number (UTN)
U1111-1174-3259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 296904 0
Condition category
Condition code
Cancer 297138 297138 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positron emission tomography / computed tomography (PET/CT) scan following intravenous administration of Gallium-68 THP-PSMA
- administered activity of 250 MBq as a single bolus administration
- scanning commencing following injection encompassing field-of-view from vertex to upper thighs immediately
- total duration of imaging 3 hours
Intervention code [1] 293363 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296754 0
To assess Ga-68 THP-PSMA safety
Timepoint [1] 296754 0
- vital signs following THP-PSMA injection
- blood tests (full blood count, urea and electrolytes, liver function tests) 24 hours following injection
- telephone follow-up at 24 hours
Primary outcome [2] 296755 0
To assess the biodistribution of Ga-68 THP-PSMA
Timepoint [2] 296755 0
Analysis of PET images throughout 3 hour scan period:: description of standardised uptake value (SUV) in normal tissues
Primary outcome [3] 296765 0
To calculate radiation dosimetry of Ga-68 THP-PSMA
Timepoint [3] 296765 0
Analysis of PET images throughout the 3 hour scan period: radiation dosimetry expressed as microSv/MBq of administered activity
Secondary outcome [1] 319271 0
To assess optimal imaging time for Ga-68 THP-PSMA using assessment of dynamic PET scans
Timepoint [1] 319271 0
At time of scanning
- qualitative assessment by visual analysis of the images at different time points
Secondary outcome [2] 319272 0
Determine by immunohistochemistry expression of PSMA relationship to Ga-68 THP-PSMA uptake as determined by PET scanning
Timepoint [2] 319272 0
Visual analysis of PSMA uptake within prostate gland compared to PSMA immunohistochemistry from surgical specimen following prostatectomy

Eligibility
Key inclusion criteria
1. Age 18 – 80 years
2. Proven adenocarcinoma of the prostate gland.
3. All patients have to be suitable for surgical treatment as part of their normal management
4. Able to comply with treatment plans, scheduled visits, all study PET imaging and follow-up
Minimum age
18 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any prior treatment for the prostate gland tumours

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
Phase 0
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive. The sample size of 14 patients is a pragmatic sample size for an exploratory phase 0 study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/12/2015
Actual
4/12/2015
Date of last participant enrolment
Anticipated
1/06/2016
Actual
1/02/2017
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4803 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 12309 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 292484 0
Commercial sector/Industry
Name [1] 292484 0
Theragnostics Ltd
Country [1] 292484 0
United Kingdom
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 291193 0
None
Name [1] 291193 0
Address [1] 291193 0
Country [1] 291193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293949 0
Peter MacCallum Cancer Centre Ethic Committee
Ethics committee address [1] 293949 0
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 293949 0
Australia
Date submitted for ethics approval [1] 293949 0
Approval date [1] 293949 0
30/11/2015
Ethics approval number [1] 293949 0
15/115

Summary
Brief summary
The primary aim of this study is to test the safety as well as define the normal and abnormal scan appearances following injection of a radioactive substance called Gallium-68 tris-hydroxypyridinone – prostate specific membrane antigen (Ga-68 THP-PSMA) and imaging with positron emission tomography (PET).

Who is it for? You may be eligible to join this study if you have prostate adenocarcinoma and are scheduled to undergo a prostatectomy.

Study details: In this study, we will use a radioactive molecule (called Gallium-68) that, after injection into a vein, specifically attaches to prostate cancer cells by binding to a receptor called PSMA. You will need to visit the hospital for an additional occasion for approximately 4 hours. An intravenous line will be inserted into a vein in each arm, one to give the investigational product, and another for sampling your blood during the scan. Ga-68 THP-PSMA will be injected and several scans performed over a 3 hour period. You will be closely observed throughout this period with regular recording of your vital signs.

The radioactive molecule used in this study is not approved by the Therapeutic Goods Administration (TGA). This study will help inform the utility of this agent for imaging prostate cancer, and design of future larger studies assessing accuracy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61894 0
A/Prof Michael Hofman
Address 61894 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 61894 0
Australia
Phone 61894 0
+61396561852
Fax 61894 0
Email 61894 0
[email protected]
Contact person for public queries
Name 61895 0
Michael Hofman
Address 61895 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 61895 0
Australia
Phone 61895 0
+61396561852
Fax 61895 0
Email 61895 0
[email protected]
Contact person for scientific queries
Name 61896 0
Michael Hofman
Address 61896 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 61896 0
Australia
Phone 61896 0
+61396561852
Fax 61896 0
Email 61896 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCold kit PSMA imaging: First in-man study of 68Ga-THP-PSMA PET/CT in patients with prostate cancer.2017
N.B. These documents automatically identified may not have been verified by the study sponsor.