ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1174-3259

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

prostate cancer

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To assess Ga-68 THP-PSMA safety

Timepoint [1]

- 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]

To assess the biodistribution of Ga-68 THP-PSMA

Timepoint [2]

Analysis of PET images throughout 3 hour scan period:: description of standardised uptake value (SUV) in normal tissues

Primary outcome [3]

To calculate radiation dosimetry of Ga-68 THP-PSMA

Timepoint [3]

Analysis of PET images throughout the 3 hour scan period: radiation dosimetry expressed as microSv/MBq of administered activity

Secondary outcome [1]

To assess optimal imaging time for Ga-68 THP-PSMA using assessment of dynamic PET scans

Timepoint [1]

At time of scanning
- qualitative assessment by visual analysis of the images at different time points

Secondary outcome [2]

Determine by immunohistochemistry expression of PSMA relationship to Ga-68 THP-PSMA uptake as determined by PET scanning

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Institute - East Melbourne

Recruitment postcode(s) [1]

3002 - East Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Theragnostics Ltd

Address [1]

The Barn, Manor Farm, Church Lane, Chilcompton, Radsock, Avon BA3 4HP

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Ethic Committee

Ethics committee address [1]

Level 4, 10 St Andrews Place
East Melbourne, VIC 3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/11/2015

Ethics approval number [1]

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

A/Prof Michael Hofman

Address

Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

+61396561852

Fax

[email protected]

Contact person for public queries

Name

Michael Hofman

Address

Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

+61396561852

Fax

[email protected]

Contact person for scientific queries

Name

Michael Hofman

Address

Peter MacCallum Cancer Centre
7 St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

+61396561852

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Cold 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.

Trial Review

Documents added manually

Documents added automatically