Trial Review

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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] 301523 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 317881 0
Condition category
Condition code
Cancer 315923 315923 0 0
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] 317834 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324133 0
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] 324133 0
On the completion of the second PET imaging scan for each participant who undergoes two Ga68-PSMA PET-CT scans.
Primary outcome [2] 324134 0
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] 324134 0
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] 324774 0
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] 324774 0
On the completion of the second PET imaging scan for each participant who undergoes two F18-PSMA PET-CT scans.
Secondary outcome [1] 387171 0
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] 387171 0
On the completion of the second PET imaging scan for each participant who undergoes two Ga68-PSMA PET-CT scans.
Secondary outcome [2] 387172 0
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] 387172 0
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?
No
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
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16916 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 30569 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305965 0
Government body
Name [1] 305965 0
Western Australian Dept of Health
Country [1] 305965 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 306422 0
None
Name [1] 306422 0
Address [1] 306422 0
Country [1] 306422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306205 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 306205 0
Ethics committee country [1] 306205 0
Australia
Date submitted for ethics approval [1] 306205 0
Approval date [1] 306205 0
11/03/2020
Ethics approval number [1] 306205 0

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

Contacts
Principal investigator
Name 103086 0
Dr Jeremy Ong
Address 103086 0
Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 103086 0
Australia
Phone 103086 0
+61 8 6457 2322
Fax 103086 0
Email 103086 0
[email protected]
Contact person for public queries
Name 103087 0
Joanne Watts
Address 103087 0
Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 103087 0
Australia
Phone 103087 0
+61 8 6457 2179
Fax 103087 0
Email 103087 0
[email protected]
Contact person for scientific queries
Name 103088 0
Joanne Watts
Address 103088 0
Dept Nuclear Medicine
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 103088 0
Australia
Phone 103088 0
+61 8 6457 2179
Fax 103088 0
Email 103088 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


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
EmbaseProspective 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.2023https://dx.doi.org/10.1259/bjr.20221178
N.B. These documents automatically identified may not have been verified by the study sponsor.