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Trial registered on ANZCTR


Registration number
ACTRN12614000877684
Ethics application status
Approved
Date submitted
8/08/2014
Date registered
19/08/2014
Date last updated
19/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
18-Fluoride (18F) labelled Sodium Fluoride (NaF)) Positron Emission Tomography (PET)/Computer Tomography (CT); the impact on pre-operative staging of intermediate and high risk prostate cancer
Scientific title
In a pilot study looking at men with intermediate or high risk prostate cancer, we wish to investigate the incremental management impact of staging with NaF PET/CT compared to bone scintigraphy
Secondary ID [1] 285127 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
 292685 0
Condition category
Condition code
Cancer 293001 293001 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All men will undergo both the NaF PET/CT as well as the Bone Scintigraphy (BS) only once (at the time of prostate cancer diagnosis). These will be done within a three day period and most likely on two consecutive days; both scans cannot be done on the same day.
The PET/CT uses the radio-active marker 18F NaF which is injected intravenously. The patient will then be scanned, roughly 45-90 minutes later. This scan picks up abnormalities within bone, but is more sensitive than the Bone Scintigraphy.
Within the next two days, the patient will then undergo the Bone Scintigraphy.
Intervention code [1] 289977 0
Diagnosis / Prognosis
Comparator / control treatment
Bone Scintigraphy (BS) is a nuclear scanning test used to pick up abnormalities in bone. It involved the intravenous injection of Technetium (99mTc) medronic acid. It is a very common investigation and is the standard staging modality for prostate cancer. Each scan takes around one hour and for this study, will be undertaken just once.
Control group
Active

Outcomes
Primary outcome [1] 292863 0
Investigate the incremental management impact of staging with 18F labelled NaF PET/CT in patients with intermediate to high risk prostate cancer. This will be done by using an ‘assessment of impact’ proforma which denotes high, medium, low and no impact to a management regimen based on certain changes in management intent and modality of therapy.Surgeons will record the management plan and goals of treatment (cure/palliative) upon viewing of the BS. At this stage they will be blinded to the PET/CT. Upon documentation, the PET/CT will become available for viewing and the surgeon will be asked to record their management plan and goals of treatment with the information gathered from the PET/CT
Timepoint [1] 292863 0
At time of diagnosis
Secondary outcome [1] 309822 0
Compare the detection of bone metastases by 99m-Tc-MDP Bone Scintigraphy (BS) and 18F labelled NaF PET/CT in patients with intermediate and high risk prostate cancer
Timepoint [1] 309822 0
At time of diagnosis

Eligibility
Key inclusion criteria
All men aged 18 years and above with newly diagnosed, untreated biopsy confirmed prostate cancer with
intermediate to high risk prostate cancer as defined by D’Amico Classification (Gleason score equal to/greater than 7 , PSA greater/equal to 10)
Minimum age
18 Years
Maximum age
100 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with a second (non-prostate) cancer
Men who have had previous neo-adjuvant hormonal or radiation therapy for prostate cancer.
Men unable to give informed consent

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)
Men will be recruited from both the Urology Department at the Royal Adelaide Hospital as well as those attending the South Terrace Urology Clinic in Adelaide. All men will under go both scans.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2822 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8509 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289736 0
Commercial sector/Industry
Name [1] 289736 0
South Australia Health and Medical Research Institute (SAHMRI)
Country [1] 289736 0
Australia
Primary sponsor type
Individual
Name
Dr. Simon Harley
Address
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Country
Australia
Secondary sponsor category [1] 288429 0
Individual
Name [1] 288429 0
Dr. Barry Chatterton
Address [1] 288429 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Country [1] 288429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291471 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 291471 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Ethics committee country [1] 291471 0
Australia
Date submitted for ethics approval [1] 291471 0
Approval date [1] 291471 0
16/07/2014
Ethics approval number [1] 291471 0
HREC/14/RAH/171

Summary
Brief summary
This study will investigate the management impact of staging with a diagnostic scan known as 18-F Sodium Fluoride PET/CT compared to bone scintigraphy in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged at least 18 years with newly diagnosed, untreated, biopsy confirmed, intermediate to high risk prostate cancer. Study details: All participants in this study will undergo two different diagnostic tests. The first test is called 18-F Sodium Fluoride Positron Emission Tomography (PET)/Computed Tomography (CT), and this involves the injection of a small amount of radioactive tracer into your veins. You body is then scanned to look for areas of tracer-uptake which may suggest cancer in your bones. The second test is called bone scintigraphy, and this involves a different radioactive tracer. Surgeons will first view the bone scintigraphy and use this to record a management plan and treatment goals. They will then view the 18-F Sodium Fluoride PET/CT and record a separate management plan. It is suggested that 18-F Sodium Fluoride PET/CT can pick up prostate cancer that has spread to the bone better than Bone Scintigraphy (BS). We wish to assess whether having access to 18-F Sodium Fluoride PET/CT actually changes the surgeons intended management of men with intermediate to high risk prostate cancer, and whether the detection of bone metastases (cancer spread to bone) is different between tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50546 0
Dr Simon Harley
Address 50546 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Country 50546 0
Australia
Phone 50546 0
+61 (08) 8222 4000
Fax 50546 0
Email 50546 0
[email protected]
Contact person for public queries
Name 50547 0
Simon Harley
Address 50547 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Country 50547 0
Australia
Phone 50547 0
+61 (08) 8222 4000
Fax 50547 0
Email 50547 0
[email protected]
Contact person for scientific queries
Name 50548 0
Simon Harley
Address 50548 0
The Royal Adelaide Hospital
North Terrace, Adelaide, SA
5000
Country 50548 0
Australia
Phone 50548 0
+61 (08) 8222 4000
Fax 50548 0
Email 50548 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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