Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001307291
Ethics application status
Approved
Date submitted
28/06/2018
Date registered
3/08/2018
Date last updated
9/09/2019
Date data sharing statement initially provided
9/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for intermediate-high risk prostate cancer diagnosis: The SAMURAI Trial
Scientific title
Diagnostic accuracy and clinical utility of PSMA PET/MRI Scanning in Prostate Cancer: The SAMURAI Trial
Secondary ID [1] 295316 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAMURAI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 308510 0
Condition category
Condition code
Cancer 307482 307482 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Simultaneous hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) scanning for prostate cancer using the Siemens Biograph mMR hybrid PET/MRI machine.
The intervention will involve using the already injected Ga68 PSMA radiotracer (dose is weight based) from standard clinical care to perform an additional PET/MRI scan. The scan is done immediately after the patient has undergone the control treatment, a Ga68 PSMA PET/CT scan, as part of standard clinical care. No additional radiotracer will need to be injected. The patient will travel to another facility containing the PET/MRI machine. A PET/MRI nuclear medicine technologist will perform the scan, and the images will be interpreted and reported by a nuclear medicine physician. The intervention will only be performed once, taking around 30 minutes to 1 hour, at a research imaging facility in metropolitan Melbourne.
Intervention code [1] 301644 0
Diagnosis / Prognosis
Comparator / control treatment
All patients who undergo the PET/MRI scan will also be undergoing imaging and investigations as part of standard clinical care. This includes an multiparametric prostate MRI scan, a transperineal biopsy and a Ga68 PSMA PET/CT scan.
Control group
Active

Outcomes
Primary outcome [1] 306479 0
Sensitivity & specificity of PSMA PET/MRI, compared to gold standard whole mount histopathology and other imaging modalities (PSMA PET/CT, multiparametric MRI), for detecting primary prostate cancer.
Timepoint [1] 306479 0
At the time of scan and at the point when the participant has undergone radical prostatectomy with whole mount histopathology
Primary outcome [2] 306481 0
Negative and positive predictive values of PSMA PET/MRI, compared to gold standard whole mount histopathology and other imaging modalities (PSMA PET/CT, multiparametric MRI), for detecting primary prostate cancer.
Timepoint [2] 306481 0
At the time of scan and at the point when the participant has undergone radical prostatectomy with whole mount histopathology
Primary outcome [3] 306485 0
Accuracy in localisation, assessed by comparing the % of positive PIRADS sector maps of PSMA PET/MRI to volumetric and histopathological reports from whole mount histopathology, to determine the accuracy in a proportional and visual sense.
Timepoint [3] 306485 0
At the time of scan and at the point when the participant has undergone radical prostatectomy with whole mount histopathology
Secondary outcome [1] 348646 0
Healthcare resource cost-effectiveness, assessed through analysing the cost per patient, estimating resources and costs and incremental costs and outcomes.
Timepoint [1] 348646 0
6 months pre radical prostatectomy (analysing all costs associated with detection and diagnosis) as well as 1 year post radical prostatectomy (to assess it's impact on treatment and costs associated).

Eligibility
Key inclusion criteria
Inclusion criteria:

(1) adult 18 years of age and above with new transperineal/transrectal biopsy diagnosed prostate cancer

(2) male sex

(3) eligible for definitive treatment with radical prostatectomy (based on age, medical co-morbidities, past history, disease progression/severity, life expectancy or other factors), as determined by the treating urologist

(4) eligible to undergo a Ga68 PSMA PET/CT scan as part of standard clinical care

(5) biopsy diagnosed cancer is intermediate risk prostate cancer or higher (greater than or equal to Gleason 3+4=7 or Grade Group 2)

(6) Signed, written, informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

(1) <18 years old

(2) low risk prostate cancers (Less than or equal to Gleason 3+3=6 or Grade Group 1)

(3) previously diagnosed prostate cancers (includes treated and untreated prostate cancers)

(4) ineligible for definitive treatment with radical prostatectomy due to age, medical co-morbidities, past history, disease progression/severity, life expectancy or other factors as determined by the treating urologist

(5) contraindications to injection of Gallium 68 labelled PSMA radiotracer, magnetic resonance imaging and 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
50
Accrual to date
34
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299906 0
University
Name [1] 299906 0
Monash University, Monash Biomedical Imaging
Country [1] 299906 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Urology Associates
Address
322 Glenferrie Rd, Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 299273 0
None
Name [1] 299273 0
Address [1] 299273 0
Country [1] 299273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300775 0
Monash University Human Ethics Committee
Ethics committee address [1] 300775 0
Ethics committee country [1] 300775 0
Australia
Date submitted for ethics approval [1] 300775 0
Approval date [1] 300775 0
07/12/2016
Ethics approval number [1] 300775 0
0780

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

Contacts
Principal investigator
Name 84778 0
A/Prof Jeremy Grummet
Address 84778 0
Central Park Specialist Centre, 389 Wattletree Rd, Malvern East VIC 3145
Country 84778 0
Australia
Phone 84778 0
+61 499 037 900
Fax 84778 0
+61 3 8888 4951
Email 84778 0
ccs-samurai.study@monash.edu
Contact person for public queries
Name 84779 0
Jeremy Cheng
Address 84779 0
Central Park Specialist Centre, 389 Wattletree Rd, Malvern East VIC 3145
Country 84779 0
Australia
Phone 84779 0
+61 499 037 900
Fax 84779 0
+61 3 8888 4951
Email 84779 0
ccs-samurai.study@monash.edu
Contact person for scientific queries
Name 84780 0
Jeremy Grummet
Address 84780 0
Central Park Specialist Centre, 389 Wattletree Rd, Malvern East VIC 3145
Country 84780 0
Australia
Phone 84780 0
+61 499 037 900
Fax 84780 0
+61 3 8888 4951
Email 84780 0
ccs-samurai.study@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All clinical and imaging and technical data, which is thoroughly de identified and unidentifiable.
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Case-by-case basis at the discretion of the investigation team.
Available for what types of analyses?
Case-by-case basis at the discretion of the investigator team.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.


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.