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Trial registered on ANZCTR


Registration number
ACTRN12619000460101
Ethics application status
Approved
Date submitted
14/03/2019
Date registered
20/03/2019
Date last updated
29/09/2020
Date data sharing statement initially provided
20/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Comparison of fluorine- and gallium-labelled Prostate Specific Membrane Antigen (PSMA) radiotracers, using Positron Emission Tomography (PET-CT), in primary and suspected recurrent Prostate Cancer (PSMA-PET-PROFILE)
Scientific title
A Prospective Comparison of 18F-PSMA-1007 and 68Ga-PSMA-11, using PET-CT, in primary and suspected recurrent Prostate Cancer
Secondary ID [1] 297702 0
Nil known
Universal Trial Number (UTN)
U1111-1229-9647
Trial acronym
PROstate Fluorine Imaging Ligand Evaluation - PSMA-PET-PROFILE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 312006 0
Condition category
Condition code
Cancer 310570 310570 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to compare two PET radiotracers in primary and recurrent prostate cancer.
The protein PSMA (Prostate Specific Membrane Antigen) is commonly present in high levels in prostate cancer, and this study uses two radiotracers that specifically target PSMA to identify sites of prostate cancer (routinely-used 68Ga-PSMA-11 and the newer 18F-PSMA-1007).

All patients will have two PSMA PET-CT scans, performed within 4-7 days of each other. The scan order will be randomised but unblinded:
One 68Ga-PSMA-11 PET-CT scan, with tracer injected intravenously 50 minutes prior to scanning. This is a routine scan that will be reported as per standard of care. The dose of this scan will be 180-250MBq.
One 18F-PSMA-1007 PET-CT scan, with tracer injected intravenously 3 hours prior to scanning. This scan is investigational, and will not be reported. The dose of this scan will be 180-360MBq

An optional 'kinetics' subcohort of 40 patients who agree to participate will have additional PET-CT scans, at 1h, 2h, and 3h after injection with the 18F-PSMA tracer, in order to measure the kinetics of tracer localisation. No additional time or tracer injection is required, but patients will be exposed to a small amount of extra radiation from the ultra low dose CT scans involved with the extra scanning procedures.

Patients will be followed up three months post scanning for subsequent treatment, and for histopathological validation of imaging if patients had subsequent lymph node dissection.
Intervention code [1] 313933 0
Diagnosis / Prognosis
Intervention code [2] 313934 0
Early detection / Screening
Comparator / control treatment
The 68Ga-PSMA scan is the current standard-of-care, and will be used as the control scan against which the 18F-PSMA scan is compared.
Control group
Active

Outcomes
Primary outcome [1] 319423 0
The primary outcome will be the number of lesions detected with each PET tracer, and overlap of the detected sites of disease.
Timepoint [1] 319423 0
50 minutes following injection of the 68Ga-PSMA tracer; 180 minutes following injection of the 18F-PSMA tracer.
Primary outcome [2] 319424 0
SUVmax of lesions detected by each scanning modality
Timepoint [2] 319424 0
50 minutes following injection of the 68Ga-PSMA tracer; 180 minutes following injection of the 18F-PSMA tracer.
Secondary outcome [1] 368093 0
Sensitivity/specificity of lesion detection for each imaging modality. Where available, for patients who undergo subsequent lymph node dissection, lesions detected on each scan will be compared to lesions detected pathologically. These will be categorised as false positive/negative or true positive/negative, to determine specificity and sensitivity.
Timepoint [1] 368093 0
Lymph node dissections within 3 months after scanning.
Secondary outcome [2] 368116 0
Examine the kinetics of 18F-PSMA uptake in the kinetics subcohort of patients, by measurement of tracer uptake (SUVmax) of lesions and organs (bladder, liver, kidneys) over time (1h, 2h, 3h after tracer injection), as measured on each PET scan.
Timepoint [2] 368116 0
60, 120, and 180 minutes following injection of the 18F-PSMA tracer

Eligibility
Key inclusion criteria
1) be >= 18 years of age
2) have a confirmed diagnosis of prostate cancer from:
a) a biopsy-confirmed diagnosis of prostate cancer;
b) suspected recurrent prostate cancer after primary treatment; there is no study-specific PSA threshold value for biochemical recurrence, but rather the assessment of suspected recurrence is left to the referring Dr;
3) have a management question, for which a PSMA PET-CT scan is indicated and,
4) be willing to have two PET-CT scans on separate days.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) unable to provide written informed consent for the study and,
2) unable to lie flat for the scans

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13369 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25969 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302225 0
Hospital
Name [1] 302225 0
Department of Molecular Imaging, Royal Prince Alfred Hospital
Country [1] 302225 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Level 11, KGV Building
Missenden Road
CAMPERDOWN NSW 2050
Country
Australia
Secondary sponsor category [1] 302078 0
None
Name [1] 302078 0
Address [1] 302078 0
Country [1] 302078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302905 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302905 0
Ethics committee country [1] 302905 0
Australia
Date submitted for ethics approval [1] 302905 0
15/03/2019
Approval date [1] 302905 0
05/06/2019
Ethics approval number [1] 302905 0

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

Contacts
Principal investigator
Name 91798 0
Prof Michael Fulham
Address 91798 0
Royal Prince Alfred Hospital, Department of Molecular Imaging,
Building 63 Level A7 Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 91798 0
Australia
Phone 91798 0
+61 2 9515 8547
Fax 91798 0
Email 91798 0
michael.fulham@sydney.edu.au
Contact person for public queries
Name 91799 0
Lyndal Alchin
Address 91799 0
Royal Prince Alfred Hospital, Department of Molecular Imaging,
Building 63 Level A7 Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 91799 0
Australia
Phone 91799 0
+61 02 95155122
Fax 91799 0
Email 91799 0
lyndal.alchin@health.nsw.gov.au
Contact person for scientific queries
Name 91800 0
Lyndal Alchin
Address 91800 0
Royal Prince Alfred Hospital, Department of Molecular Imaging,
Building 63 Level A7 Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 91800 0
Australia
Phone 91800 0
+61 02 9515 5122
Fax 91800 0
Email 91800 0
lyndal.alchin@health.nsw.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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.