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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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

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
Can healthy volunteers participate?
Key exclusion criteria
1. Any prior treatment for the prostate gland tumours

Study design
Purpose of the study
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 0
Type of endpoint(s)
Statistical methods / analysis
Descriptive. The sample size of 14 patients is a pragmatic sample size for an exploratory phase 0 study.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Address [1] 292484 0
The Barn, Manor Farm, Church Lane, Chilcompton, Radsock, Avon BA3 4HP
Country [1] 292484 0
United Kingdom
Primary sponsor type
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Secondary sponsor category [1] 291193 0
Name [1] 291193 0
Address [1] 291193 0
Country [1] 291193 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 293949 0
Approval date [1] 293949 0
Ethics approval number [1] 293949 0

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

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
Phone 61894 0
Fax 61894 0
Email 61894 0
Contact person for public queries
Name 61895 0
A/Prof Michael Hofman
Address 61895 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 61895 0
Phone 61895 0
Fax 61895 0
Email 61895 0
Contact person for scientific queries
Name 61896 0
A/Prof Michael Hofman
Address 61896 0
Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002
Country 61896 0
Phone 61896 0
Fax 61896 0
Email 61896 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary