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Trial registered on ANZCTR


Registration number
ACTRN12618000665235
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
24/04/2018
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Date results information initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Compare and contrast of two prostate-specific membrane antigen (PSMA) PET tracer aids for detecting and staging prostate cancers.
Scientific title
A prospective, intra-individual, blinded, comparison of the diagnostic accuracy of 18F-PSMA-1007 and 68Ga-PSMA-11 imaging in patients with confirmed prostate cancer
Secondary ID [1] 294353 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 307077 0
Condition category
Condition code
Cancer 306188 306188 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two radiotracers will be utilised in this study. The first, 68Ga-PSMA-11, the current gold standard PET tracer for identifying prostate cancers. The second, 18F-PSMA-1007, will be assessed against the 68Ga-PSMA-11.
Patients will be administered 68Ga-PSMA first, then imaged, and after a period of time when the tracer has been excreted from the body, the patients will be administered 18F-PSMA and then imaged.
Patients will not need to be admitted to hospital. Patients will be injected with radiotracer according to usual standard-of-care practice and will undergo standard-of-care PET imaging 45-90 minutes post-injection.
PET imaging will start at the knees and move towards the head. Two and a half minute bed positions will be acquired from thighs to skull vertex with the exception of two bed positions over the pelvis which will be for 4 minutes. Overall, imaging should be approximately 45-60 minutes.
A nuclear medicine doctor will administer the radiotracer and analyse the imaging.
Participants will be followed up over 5 years.
The minimum period of time between the first tracer and the second tracer being administered is five half-lives (approx. 340 minutes). The maximum period of time between tracers being administered is two weeks.
All participants will have 68Ga-PSMA first followed by 18F-PSMA. This does not need to be randomised as the nuclear medicine clinician will know immediately (from the PET scan) which tracer has been used. Therefore, there is no need to randomise as there is no direct way to 'blind' the clinician as to which tracer has been used.
Intervention code [1] 300657 0
Early detection / Screening
Intervention code [2] 300790 0
Diagnosis / Prognosis
Comparator / control treatment
Two radiotracers will be utilised in this study. The first, 68Ga-PSMA-11, the gold standard tracers for identifying prostate cancers. The second, 18F-PSMA-1007 which will be assessed against the 68Ga-PSMA-11.
Patients will be administered 68Ga-PSMA first, imaged, and after a period of time when the tracer has been excreted from the body, the patients will be administered 18F-PSMA.
68Ga-PSMA is the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 305605 0
To compare the diagnostic performance of 18F-PSMA to 68Ga-PSMA for the detection of primary prostate cancer, local recurrence, regional nodal and distant metastatic prostate cancer
Timepoint [1] 305605 0
The detection of primary (T), pelvic nodal (N) or distant metastic (M) prostate cancer using PET/CT.
Secondary outcome [1] 344478 0
To compare the prostate cancer prognostic staging group classification, as determined by the Gleason System, to determine any differences in clinical management impact between the two radiotracers.

Timepoint [1] 344478 0
Impact on management as defined by a change in the prognostic staging group of the patient after consideration of the result of the 18F-PSMA-1007 examination following the initial 68Ga-PSMA-11.
Secondary outcome [2] 345050 0
To report the number of acute adverse events as a result of the radiotracer. These adverse events may present as a transient flush, rash, fever, oedema at injection site. All adverse events will be reported as per the Common Terminology Criteria for Adverse Events, V4.03 (CTCAE)
Timepoint [2] 345050 0
Patients will undergo routine monitoring from the time of radio-tracer injection until the completion of imaging. Adverse events that occur during this time will be reported.
Secondary outcome [3] 345051 0
To compare the departmental cost of each radiotracer.
Timepoint [3] 345051 0
This will be performed at the end of the study.
Secondary outcome [4] 345052 0
Patient exposure to radiation will be measured in milliSieverts.
Patients will be exposed to a known amount of radiation from the dose of radiotracer. This amount will be written on the side of the vial upon production.
Patients will also receive some radiation exposure from the CT scan. This known amount will be recorded by the scanner and added to the amount received from the tracer.
Timepoint [4] 345052 0
Patient exposure to radiation will be calculated at the end of each scan.
Overall, differences in exposure by the two radio-tracers will be calculated at the end to the trial.

Eligibility
Key inclusion criteria
All patients:
1. Age equal to or greater than 60 years.
2. Patient has provided written informed consent for participation in this trial
3. The patient is able to comply with the required study procedures

Primary staging cohort:
1. Newly-diagnosed, untreated, biopsy proven adenocarcinoma of the prostate gland.
2. Patients must have at least one of the following features
- Gleason group 3, 4 or 5
- PSA >20 ng/mL within 12 weeks prior to referral
- Clinical stage =T3

Biochemical recurrence restaging cohort:
A. Prostatectomy cohort
1. Complete excision of the prostate gland, R0- or R1- resection
2. PSA =0.2ng/mL after nadir following radical prostatectomy

B. Radiotherapy cohort
1. Organ-preserving local treatment (external beam radiation therapy, brachytherapy, seed implantation, high intensity focused ultrasound)
2. PSA increase of 2.0ng/mL greater than the lowest recorded PSA value following therapy

Known metastatic disease restaging cohort:
1. Known distant metastatic prostate cancer (M1 a/b/c) diagnosed by at least one of the following:
- 68Ga-PSMA-11 demonstrating metastatic disease
- WBBS demonstrating lesions characteristic of prostate cancer metastases
- CT or MRI imaging demonstrating lesions characteristic of prostate cancer metastases
- Histological confirmation of prostate cancer metastasis
Minimum age
60 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant intercurrent comorbidity that, in the opinion of the investigators, would limit compliance with the study protocol
2. Change in prostate cancer therapy after the 68Ga-PSMA-11 PET/CT but before the 18F-PSMA-1007 PET/CT.

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
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
All patients will be assessed for primary, nodal and metastatic disease using 68Ga-PSMA-11 PET/CT as the first line diagnostic imaging modality. Focal 68Ga-PSMA-11 activity with imaging appearances characteristic of prostate cancer will be considered positive for disease. Similarly, imaging findings characteristic of prostate cancer on 18F-PSMA-1007 will also be considered positive for disease. Findings which are deemed equivocal will be considered negative for the purposes of analysis. A two sided McNemar test will be performed to analyse whether 18F-PSMA-1007 detects more lesions characteristic for prostate cancer than 68Ga-PSMA-11.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10399 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 22079 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 298996 0
Hospital
Name [1] 298996 0
Department of Nuclear Medicine, Royal Brisbane and Women's Hospital
Address [1] 298996 0
Level 3, Ned Hanlon Building,
Butterfield Street,
Herston, 4029,
Brisbane, Queensland
Country [1] 298996 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Level 3, Ned Hanlon Building,
Butterfield Street,
Herston, 4029,
Brisbane, Queensland.
Country
Australia
Secondary sponsor category [1] 298221 0
None
Name [1] 298221 0
None
Address [1] 298221 0
None
Country [1] 298221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299925 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 299925 0
Level 7, Block 7,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, 4029,
Brisbane, Queensland
Ethics committee country [1] 299925 0
Australia
Date submitted for ethics approval [1] 299925 0
27/11/2017
Approval date [1] 299925 0
09/02/2018
Ethics approval number [1] 299925 0
HREC/17/QRBW/686

Summary
Brief summary
The purpose of this study is to determine if the radio-tracer 18F-PSMA-1007 has similar diagnostic accuracy to the radio-tracer 68Ga-PSMA-11 in patients with prostate cancer metastasis.

Who is it for?
You may be eligible for this study if you are aged 60 and above and currently have prostate cancer.

Study details.
Participants will receive a PET scan using the radio-tracer 68Ga-PSMA-11 as normal standard-of-care. Participants will be asked to return for a second PET scan within two weeks of the first PET scan. This second PET scan will be performed using the radio-tracer 18F-PSMA-1007.

The only tests involved with this study will be PET scans.

By comparing the two radio-tracers (68Ga-PSMA and 18F-PSMA) we hope to validate the use of 18F-PSMA for diagnostic use in screening and staging prostate cancers. 18F-PSMA has slightly different properties to 68Ga-PSMA that will make it a more versatile tool for diagnosing prostate cancer. Its longer half-life means that 18F-PSMA will be able to be shipped to regional centres to be used instead of cancer patients having to travel to a large metropolitan hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82006 0
Dr David Pattison
Address 82006 0
Department of Nuclear Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, 4029,
Brisbane, Queensland
Country 82006 0
Australia
Phone 82006 0
+61 7 36467225
Fax 82006 0
Email 82006 0
david.pattison@health.qld.gov.au
Contact person for public queries
Name 82007 0
Dr David Pattison
Address 82007 0
Department of Nuclear Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, 4029.
Brisbane, Queensland.
Country 82007 0
Australia
Phone 82007 0
+61 7 36467225
Fax 82007 0
Email 82007 0
david.pattison@health.qld.gov.au
Contact person for scientific queries
Name 82008 0
Dr David Pattison
Address 82008 0
Department of Nuclear Medicine,
Royal Brisbane and Women's Hospital,
Butterfield Street,
Herston, 4029.
Brisbane, Queensland
Country 82008 0
Australia
Phone 82008 0
+61 7 36467225
Fax 82008 0
Email 82008 0
david.pattison@health.qld.gov.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 2078 0
Conference poster
Citation/DOI/link/details [1] 2078 0
Presented at ANZSNM Annual Scientific Meeting on 27 & 28/4/19.
Attachments [1] 2078 0
Results – basic reporting
Results – plain English summary