ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001110976

Ethics application status

Approved

Date submitted

16/06/2020

Date registered

27/10/2020

Date last updated

27/10/2020

Date data sharing statement initially provided

27/10/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Determining the repeatability of measurements in metastatic prostate cancer using prostate-specific PET scan imaging

Scientific title

Repeatability of quantitative measures in metastatic prostate cancer using PSMA-based PET

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

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

Participants in this study will receive one additional Prostate Specific Membrane Antigen (PSMA) PET scan above normal standard of care within 2 weeks of the initial scan. Participants will be allocated to receive either two Gallium 68 (Ga 68)-PSMA PET scans, two Fluorine 18 (F18)-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). In total, study participation will involve one additional visit to hospital in order to have a second PSMA PET scan. The time required for this visit will be 2 – 3 hours. The additional PET scan is for research only and will not be used to change prostate cancer treatment. Scan attendance will be monitored and recorded by study data management personnel.

Each PSMA PET scan includes the following procedures which are performed in a single visit:
- A needle is inserted into a hand or arm vein by a Nuclear Medicine Nurse or Technologist and a small amount of the radioactive PSMA is injected (1.7 MBq/kg Ga68 PSMA or 4 MBq/kg F18 PSMA).
- This is followed by a wait of 1-2 hours. During this time, the PSMA travels through the blood stream and is taken up by prostate cancer cells. It has a small amount of radioactivity which is detected by the scanner.
-Participants are then positioned on the bed of the scanner to get PET and CT pictures of body the from head to thighs. The total time in the scanner is around 20 minutes.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The intra-patient repeatability of Ga68-PSMA-11 PET-CT quantitative parameters for the evaluation of disease progression in metastatic prostate cancer will be assessed by analysis of individual lesions using research-dedicated analysis software (MiM Software Inc).

Timepoint [1]

On the completion of the second PET imaging scan for each participant who undergoes two Ga68-PSMA PET-CT scans.

Primary outcome [2]

The intra-patient variability between Ga68-PSMA-11 and F18-PSMA-1007 PET-CT quantitative parameters for the evaluation of disease progression in metastatic prostate cancer will be assessed by analysis of individual lesions using research-dedicated analysis software (MiM Software Inc).

Timepoint [2]

On the completion of the second PET imaging scan for each participant who undergoes one Ga68-PSMA and one F18-PSMA PET-CT scan in any order.

Primary outcome [3]

The intra-patient repeatability of F18-PSMA-1007 PET-CT quantitative parameters for the evaluation of disease progression and treatment response in metastatic prostate cancer will be assessed by analysis of individual lesions using research-dedicated analysis software (MiM Software Inc).

Timepoint [3]

On the completion of the second PET imaging scan for each participant who undergoes two F18-PSMA PET-CT scans.

Secondary outcome [1]

Primary outcome: The intra-patient repeatability of Ga68-PSMA-11 PET-CT quantitative parameters for the evaluation of treatment response in metastatic prostate cancer will be assessed by analysis of individual lesions using research-dedicated analysis software (MiM Software Inc).

Timepoint [1]

On the completion of the second PET imaging scan for each participant who undergoes two Ga68-PSMA PET-CT scans.

Secondary outcome [2]

Primary outcome: The intra-patient variability between Ga68-PSMA-11 and F18-PSMA-1007 PET-CT quantitative parameters for the evaluation of treatment response in metastatic prostate cancer will be assessed by analysis of individual lesions using research-dedicated analysis software (MiM Software Inc).

Timepoint [2]

On the completion of the second PET imaging scan for each participant who undergoes one Ga68-PSMA and one F18-PSMA PET-CT scan in any order.

Eligibility

Key inclusion criteria

• Metastatic prostate cancer with evidence of PSA progression
• No change in prostate cancer specific treatment in the previous 12 weeks.
• Males greater than 18 years old.
• Able to provide informed consent and undergo study procedures.

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

• Unable to provide informed consent.
• Other active neoplastic disease

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

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

28/07/2020

Date of last participant enrolment

Anticipated

30/11/2020

Actual

Date of last data collection

Anticipated

14/12/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Western Australian Dept of Health

Address [1]

PO Box 8172
Perth Business Centre
Perth WA 6849
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee

Ethics committee address [1]

Level 2, A Block, 
QEII Medical Centre, 
Hospital Avenue, NEDLANDS WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/03/2020

Ethics approval number [1]

Summary

Brief summary

Prostate cancer is the most commonly diagnosed cancer in Australian men. PSMA PET-CT (“prostate specific membrane antigen positron emission tomography computed tomography”), or “PSMA PET” for short, is increasingly being used for the imaging of prostate cancer. For this imaging technique, PSMA (prostate specific membrane antigen) is bound to a small amount of a radioactive imaging tracer. Two different imaging tracers are available in Western Australia, based on Gallium 68 (Ga 68) and Fluorine 18 (F18) compounds. 
This purpose of this study is to: 
•	Evaluate the consistency of PSMA PET scans when the same type of scan is repeated within a short time frame (approximately one week). 
•	Compare results of a Ga68-PSMA PET scan with results from a F18-PSMA PET scan, when both are performed within a short time frame (approximately one week apart). 

Who is it for?
You may be eligible for this study if you are a male aged 18 or older and have been diagnosed with metastatic prostate cancer, you have not had a change in your cancer treatment in the last 12 weeks and have been referred by your treating physician to have a PSMA PET scan.

Study details
All participants in this study will have one additional PSMA PET within 2 weeks of the first scan. You will be allocated to receive either two Ga68-PSMA PET scans, two F18-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). 
At each scan you will have one of the radioactive tracing agents injected into your arm, followed by a 1-2 hour wait before the scan is performed. You will then be positioned on the bed of the scanner to get PET and CT pictures of your body from head to thighs. The time in the scanner is around 20 minutes. 
In total, participation in the study will involve one additional visit to hospital in order to have a second PSMA PET. The time required for this visit will be 2 – 3 hours after which time you can return home without further assessments.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jeremy Ong

Address

Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 6457 2322

Fax

jeremy.ong@health.wa.gov.au

Contact person for public queries

Name

Joanne Watts

Address

Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 6457 2179

Fax

NuclearMedicineResearch.SCGH@health.wa.gov.au

Contact person for scientific queries

Name

Joanne Watts

Address

Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia

Country

Australia

Phone

+61 8 6457 2179

Fax

NuclearMedicineResearch.SCGH@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Prospective inter-and intra-tracer repeatability analysis of radiomics features in [68Ga]Ga-PSMA-11 and [18F]F-PSMA-1007 PET scans in metastatic prostate cancer.	2023	https://dx.doi.org/10.1259/bjr.20221178

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically