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Trial registered on ANZCTR


Registration number
ACTRN12608000641392
Ethics application status
Approved
Date submitted
24/09/2008
Date registered
17/12/2008
Date last updated
6/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utility of 18F-fluorocholine positron emission tomography in prostate cancer.
Scientific title
A randomised trial comparing 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) with Conventional Imaging (computed tomography and whole-body bone scan) with respect to their first-line utility in the staging or restaging of patients with prostate cancer.
Secondary ID [1] 283783 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 3845 0
Condition category
Condition code
Cancer 4035 4035 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positron emission tomography/computed tomography with 18F-fluorocholine (FCH-PET/CT)
Positron emission tomography (PET) is a nuclear medicine imaging modality using radiopharmaceuticals labelled with positron emitting isotopes (such as fluorine-18), aimed at imaging various metabolic processes in vivo. Newer PET scanners are always combined with a computed tomography scanner (PET/CT), allowing combination of PET images with anatomical CT images in order to localize precisely any PET abnormality. 18F-fluorocholine (FCH) is a PET radiopharmaceutical for imaging the metabolism of choline, a precursor of cell membranes, which is increased in tumoural cells with high cell membrane turnover, such as prostate cancer cells. The participant is given an injection of FCH prior to PET/CT scanning.
Participants will receive between 1 and 3 trial scans (CT+WBBS and/or FCH-PET/CT), as first and second-line imaging modalities. Then 6 months following the completion of treatment (of maximum 6 months duration), or after 12 months surveillance, participants will receive between 1 and 3 follow-up scans. Those patients who receive long term hormonal treatment will not receive mandated follow-up scans
Patients are randomized to either 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) or Conventional Imaging (CI)which is a combination of computed tomography (CT) and whole-body bone scan (WBBS). The randomized group determines which modalit(ies) (FCH-PET/CT or CI) the participant will have as the first-line imaging work-up. Then, the participants will receive the alternate imaging (CI or FCH-PET/CT) as a second-line imaging work-up if the first-line was negative/equivocal for distant metastasis.
This study is a diagnostic trial and does not involve any therapeutic intervention. Participant’s care is managed by the treating physician, as it would normally be if the participant were not participating in the study.
Intervention code [1] 3458 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional imaging (CI): the combination of a contrast-enhanced abdominal-pelvic computed tomography (CT) and a whole-body bone scintigraphy (WBBS)

Computed tomography (CT) is a tomographic X-ray imaging technique in radiology providing a series of transaxial images (slices) of the body. Contrast-enhanced CT involves the use of intravenous contrast agent (given to the patient as an injection prior to CT scanning) to enhance visualization of tumoural tissues. The abdominal-pelvic region of the body is scanned to assess the nodal spread of prostate cancer.

Whole-body bone scintigraphy (WBBS) is a nuclear medicine imaging technique. It involves giving the patient an injection of a radiopharmaceutical that localizes in bony structures. Three hours after the injection, the whole body is scanned from top to toe with a nuclear medicine gamma camera. The images obtained show normal skeleton, as well as pathologic bone metabolism abnormalities such as bone metastasis.

Participants will receive between 1 and 3 scans (CT+WBBS and/or FCH-PET/CT), as first and second-line imaging modality. Typically, such patients receive 2 scans in routine clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 4816 0
Primary Outcome 1: First-line imaging utility: change (or not) between management plan after the first-line imaging and management plan after second-line alternative imaging
Timepoint [1] 4816 0
Timepoint: within 8 weeks from randomisation
The primary endpoint will be assessed once. The data for the primary endpoint assessment will be collected after the first-line imaging for all participants, and after the second-line imaging for participants who have the second-line imaging performed. The staging or restaging process should be completed within 8 weeks.
Secondary outcome [1] 8130 0
Secondary Outcome 1: Second-line imaging incremental utility: change (or not) between management plan after the first-line imaging and management plan after second-line alternative imaging when first-line imaging is negative for metastasis.
Timepoint [1] 8130 0
Timepoint: within 8 weeks from randomisation
The secondary endpoint "incremental value" will be assessed once. The data for this secondary endpoint assessment will be collected after the first-line imaging and after the second-line imaging for participants who have the second-line imaging performed. Eight (8) weeks refers to the maximum duration of the staging or restaging process.
Secondary outcome [2] 8131 0
Secondary Outcome 2: Cost of each arm imaging strategy
The cost of each CI procedure will be based on current Medicare Benefits Schedule (MBS) item numbers. The nominal cost of FCH-PET/CT is AUD 1,200. The total cost will be the sum of: 1) Cost of the first-line DI workup; 2) Cost of the mandatory second-line DI workup, if any; and 3) Cost of any additional DI procedures required for validation
Timepoint [2] 8131 0
Timepoint: within 8 weeks from randomisation.
The cost endpoint will be assessed once, after the completion of staging/restaging period, which we aim to be a maximum of 8 weeks of duration.
Secondary outcome [3] 8132 0
Secondary Outcome 3: Negative predictive value of FCH-PET/CT vs CI
For participants who will not be treated with long-term hormonal therapy, we will repeat their randomized first-line imaging procedure after six months of completion of their treatment, or after 12 months of observation if they are not treated. If the first-line imaging is negative for bone metastasis, we will repeat the second-line imaging (alternate imaging). We will compare the results of the initial first-line imaging work-up to those of the repeat imaging modality(ies) to assess the negative predictive value for the initial first-line imaging.
Timepoint [3] 8132 0
Timepoint: at 6 months after randomisation
Secondary outcome [4] 8133 0
Secondary Outcome 4: Prognostic value of FCH-PET/CT vs CI
We will record the time to bone metastasis onset and/or death. The results of each imaging modality (FCH-PET/CT, CT and WBBS) will be stratified in groups (positive vs negative) and Kaplan-Mayer curves analysis will be performed for time to bone metastasis onset and/or death.
Timepoint [4] 8133 0
Timepoint: up to 10 years after randomisation
The participant's medical chart will be reviewed at 1, 3, 5 and 10 years follow-up to assess the onset of bone metastasis and death.
Secondary outcome [5] 8134 0
Secondary Outcome 5: Overall utility of imaging for staging/restaging this
population
The final management plan after the staging/restaging work-up will be compared to the provisional management plan before the staging/restaging workup for all participants. The proportion of participants for whom there is a change in the management plan will be the measure of the overall utility of imaging for the staging/restaging of this population.
Timepoint [5] 8134 0
Timepoint: within 8 weeks from randomisation
The overall utility endpoint will be assessed once, after the completion of the staging/restaging period, which we aim to be a maximum of 8 weeks duration.
Secondary outcome [6] 8135 0
Secondary Outcome 6: Documentation of suspected adverse reactions to FCH
An adverse event (AE) can be defined as any untoward medical occurrence in a patient or clinical investigation participant who is administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment (Notes for guidance on good clinical practice. Therapeutic Goods Administration. Commonwealth Department of Health and Aged Care. July 2000). All adverse events occurring after administration of FCH will be documented along with the relationship to the injection. Participants will be monitored by clinical observation until 30 minutes after administration of FCH. In the case of an anaphylactic reaction thought to be due to the FCH, the participant will be treated with medications as per the Department of Diagnostic Imaging anaphylaxis protocol. This involves different initial medications depending on the type and severity of the reaction but may include intravenous steroid, intravenous antihistamine, nebulised salbutamol or intravenous adrenaline. Any other serious adverse event (SAE) will be managed as appropriate and reported to the ethics committee. All serious adverse events will be followed until symptoms have abated or stabilised. If SAEs are experienced by 2 participants, the study will be stopped. If this should happen, we will continue to follow up the participants already registered.
Timepoint [6] 8135 0
Timepoint: within 1 week from randomisation

Eligibility
Key inclusion criteria
Biopsy-proven prostate cancer;
Age = 18 years;
Written informed consent has been provided.
Newly-diagnosed prostate cancer (Staging Population):
Patient has not undergone any form of treatment for his disease;
Non-low risk disease. He must have at least one of the following features: prostate specific antigen (PSA) = 10.0 ng/ml within 8 weeks prior to randomisation; Gleason score = 7; clinical stage = T2b.
Suspected recurrent prostate cancer (Restaging Population):
Patient has undergone local radical treatment;
Within the 8 weeks prior to randomisation, the PSA level must be = 0.5 ng/ml and rising (post-operatively) or a PSA level of 2 ng/mL or more above the nadir PSA level (post-radiotherapy).
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participant has undergone, within 8 weeks prior randomisation, a diagnostic imaging(DI) procedure for the staging (N-staging or M-staging) or restaging of his prostate cancer;
A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer;
Presently having androgen deprivation therapy started less than 6 months ago;
Where radical treatment of the patient would not be contemplated on the basis of limited expected lifespan due to comorbid conditions.

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)
Allocation concealement will be performed by central randomisation computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random assignment of a participant to FCH-PET/CT or CI arm will be undertaken via a computer program associated with the trial database. Stratification will be according to indication (staging / restaging), PSA, Gleason Score, and Initial Clinical Stage.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
VIC

Funding & Sponsors
Funding source category [1] 3920 0
Self funded/Unfunded
Name [1] 3920 0
Address [1] 3920 0
Country [1] 3920 0
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
12 St. Andrew's Place, East Melbourne, VIC, 3002
Country
Australia
Secondary sponsor category [1] 3517 0
None
Name [1] 3517 0
Address [1] 3517 0
Country [1] 3517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5983 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 5983 0
12 St. Andrew's Place, East Melbourne, VIC, 3002
Ethics committee country [1] 5983 0
Australia
Date submitted for ethics approval [1] 5983 0
Approval date [1] 5983 0
21/08/2008
Ethics approval number [1] 5983 0
08/08

Summary
Brief summary
Prostate cancer can extend beyond the prostate, most commonly to lymph nodes or bones. Determination of its extent is crucial to determining best treatment options for patients. Currently, the conventional tests that are most commonly used for this purpose are a bone scan and computed tomography but these are not very accurate and may result in inappropriate treatment. Positron emission tomography with fluorocholine (FCH-PET/CT) is a promising new test for diagnosing the extent of prostate cancer since it can detect disease in the prostate itself, lymph nodes, and bones. This project proposes to compare the utility of FCH-PET/CT with that of conventional tests for guiding treatment decisions. Patients who have a newly diagnosed prostate cancer, or in whom a relapse of prostate cancer is suspected will be randomly assigned to undergo either conventional tests or FCH-PET/CT as the initial investigation. If these show no distant spread, patients will undergo the alternative test strategy. The usefulness of each test strategy will be assessed by its influence on treatment planning. It is anticipated that FCH-PET/CT will better identify the patients who are amenable to a curative treatment and avoid futile treatments in some other patients. If FCH-PET/CT, a new and non-invasive test, proves successful, it is likely to become more widely available to patients with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28972 0
Prof Rodney Hicks
Address 28972 0
Director, Centre for Cancer Imaging, The Peter MacCallum Cancer Centre, 12 St. Andrews Place, East Melbourne VIC 3002
Country 28972 0
Australia
Phone 28972 0
61-3-9656-1852
Fax 28972 0
61-3-9656-1826
Email 28972 0
Rod.Hicks@petermac.org
Contact person for public queries
Name 12129 0
Ms Ms Elizabeth Drummond (Research Coordinator)
Address 12129 0
Centre for Cancer Imaging, 12, St. Andrew's Place, Peter MacCallum Cancer Centre, East Melbourne, VIC 3002
Country 12129 0
Australia
Phone 12129 0
61 3 9656 1856
Fax 12129 0
61-3-9656 2915
Email 12129 0
Elizabeth.Drummond@petermac.org
Contact person for scientific queries
Name 3057 0
Prof Professor Rodney Hicks (Principal Investigator)
Address 3057 0
Director, Centre for Cancer Imaging, Department of Diagnostic Imaging, The Peter MacCallum Cancer Centre, 12 St. Andrew's Place, East Melbourne, VIC 3002.
Country 3057 0
Australia
Phone 3057 0
61-3-9656-1852
Fax 3057 0
61-3-9656-1826
Email 3057 0
Rod.Hicks@petermac.org

No information has been provided regarding IPD availability
Summary results
No Results