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Trial registered on ANZCTR
Registration number
ACTRN12612001137886
Ethics application status
Approved
Date submitted
1/10/2012
Date registered
25/10/2012
Date last updated
25/10/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Can 3-Tesla Magnetic Resonance imaging of the prostate be useful in making the decision to perform prostate biopsy in men with a high or concerning prostate specific antigen (PSA) ?
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Scientific title
In men referred to a urologist with a high or concerning prostate specific antigen (PSA), can 3T multi-parametric MRI of the prostate be used as a triage for reducing the need to biopsy patients?
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Secondary ID [1]
281100
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Nil
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Universal Trial Number (UTN)
U1111-1133-8530
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate cancer
287258
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Condition category
Condition code
Cancer
287585
287585
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
a) Single treatment arm
b) multi-parametric MRI (mpMRI) prostate followed either by MRI prostate biopsy and ultrasound prostate biopsy; OR ultrasound prostate biopsy alone
Decision to perform MRI guided biopsy is based on MRI findings using PIRADS scoring system (Eur Radiol. 2012 Apr;22(4):746-57. Epub 2012 Feb 10.
) - PIRADS 1 and 2 scored MRI patients only have TRUS biopsy
- patients with MRI scored 3,4 or 5 have both an MRI guided biopsy and TRUS biopsy
c) MRI prostate - 30min; MRI prostate biopsy 40 min; US biopsy of prostate - 15 min
d) Modes - MRI and ultrasound imaging of the prostate
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Intervention code [1]
285554
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Diagnosis / Prognosis
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Intervention code [2]
285561
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Early detection / Screening
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Comparator / control treatment
TRUS-guided biopsies of the prostate.
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Control group
Active
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Outcomes
Primary outcome [1]
287845
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1. Accuracy in detection of the most aggressive prostate cancer present for mpMRI and mpMRI-guided biopsies vs. TRUS-guided biopsies for all patients by comparing biopsy results of mpMRI biopsies against TRUS guided biopsies in each patient with PIRADS score 3,4 or 5. For Patients with PIRADS score 1,2 only the mpMRI images will be compared to the biopsy results of the TRUS guided biopsies
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Assessment method [1]
287845
0
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Timepoint [1]
287845
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At conclusion of study
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Primary outcome [2]
287846
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2. Analysis of the number of biopsy cores taken to achieve diagnosis
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Assessment method [2]
287846
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Timepoint [2]
287846
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At conclusion of study
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Primary outcome [3]
287847
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3. Assess the detection or exclusion of indolent (insignificant) cancer by mpMRI and biopsy vs TRUS guided biopsy
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Assessment method [3]
287847
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Timepoint [3]
287847
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At conclusion of study
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Secondary outcome [1]
298930
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Subgroup analysis comparing mpMRI vs TRUS in patients with :
1. Palpable vs non-palpable disease
2. Different PSA quartiles eg PSA 0-2.5, 2.5-5, 5-10, over 10
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Assessment method [1]
298930
0
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Timepoint [1]
298930
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At conclusion of study
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Eligibility
Key inclusion criteria
1. Men referred to a urologist with a high or concerning PSA, or abnormal prostatic rectal examination. These men would normally proceed to TRUS biopsy under current guidelines.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Men who have had a TRUS biopsy in the past
2. Men taking 5 alpha reductase inhibitors.
3. Men who are unwilling or unfit to undergo prostate biopsies (in the opinion of the referring urologist)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients referred to the clinical trial by a urologist will be assessed by the trial team to ensure inclusion and exclusion criteria are met.
This is a non-randomzied trial in that every patient will receive both the current gold standard diagnostic test - TRUS guided prostate biopsy, as well as undergoing a mpMRI and mpMRI guided biopsy of any MRI detected lesions
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization not necessary as each patient will undergo both diagnositic interventions
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
27/06/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
225
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
285886
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Hospital
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Name [1]
285886
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The Wesley Hospital
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Address [1]
285886
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451 Coronation Drive
Auchenflower QLD 4066
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Country [1]
285886
0
Australia
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Funding source category [2]
285888
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Other
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Name [2]
285888
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Wesley Research Institute
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Address [2]
285888
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Level 8, East Wing
The Wesley Hospital
451 Coronation Drive
Auchenflower QLD 4066
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Country [2]
285888
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Australia
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Primary sponsor type
Hospital
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Name
The Wesley Hospital
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Address
451 Coronation Drive
Auchenflower QLD 4066
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Country
Australia
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Secondary sponsor category [1]
284711
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Other
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Name [1]
284711
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The Wesley Research Institute
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Address [1]
284711
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Level 8, East Wing
The Wesley Hospital
451 Coronation Drive
Auchenflower QLD 4066
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Country [1]
284711
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Australia
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Other collaborator category [1]
277044
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Hospital
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Name [1]
277044
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St Radbound University Hospital
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Address [1]
277044
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St Radbound University Hospital
6525 GA Nijmegen
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Country [1]
277044
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Netherlands
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Other collaborator category [2]
277045
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University
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Name [2]
277045
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The University of Queensland
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Address [2]
277045
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Queensland Clinical Trials & Biostatistics Centre
School of Population Health, University of Queensland
Level 1, Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
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Country [2]
277045
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287915
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Uniting Care Health Human Research Ethics Committee
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Ethics committee address [1]
287915
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The Wesley Hospital
PO Box 499
Auchenflower QLD 4066
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Ethics committee country [1]
287915
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Australia
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Date submitted for ethics approval [1]
287915
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Approval date [1]
287915
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28/05/2012
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Ethics approval number [1]
287915
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1211
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Summary
Brief summary
The study is evaluating a novel diagnostic technique for prostate cancer, known as multi-parametric magnetic resonance imaging (mpMRI).
Who is it for?
You may be eligible to join this study if you are a male who has been referred to a urologist with a high or concerning PSA (Prostate-specific antigen), or abnormal prostatic rectal examination.
Trial details
All participants in this study will undergo current treatment guidelines for diagnosis of prostate cancer, including PSA measurements and 12 core Transrectal ultrasound (TRUS) guided needle biopsies of the prostate. In addition, a highly specific imaging process, known as multi-parametric magnetic resonance imaging (multiparametric MRI or mpMRI), will be used to further assess the prostate gland and be used to take MRI guided biopsy of any MRI detected lesions. This examination takes 20-30 minutes and involves the administration of a gadolinium contrast agent.
It is anticipated that the results of this study will lead to better informed treatment of prostate cancer and suspected prostate cancer, for example by decreasing the number of men who need biopsies, decreasing the number of biopsy cores in those men who need them from 12 to 2 or 3, and decreasing the overtreatment of non-significant prostate cancer
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34626
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Address
34626
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Country
34626
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Phone
34626
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Fax
34626
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Email
34626
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Contact person for public queries
Name
17873
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Dr Leslie C Thompson
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Address
17873
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Suite 14
Level 1
Wesley Medical Centre
40 Chasely St
Auchenflower
QLD 4066
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Country
17873
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Australia
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Phone
17873
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+61 7 3371 7728
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Fax
17873
0
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Email
17873
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[email protected]
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Contact person for scientific queries
Name
8801
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Dr Leslie C Thompson
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Address
8801
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Suite 14
Level 1
Wesley Medical Centre
40 Chasely St
Auchenflower
QLD 4066
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Country
8801
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Australia
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Phone
8801
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+61 7 3371 7728
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Fax
8801
0
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Email
8801
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[email protected]
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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
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4376
Study results article
Yes
Pokorny MR, de Rooij M, Duncan E, Schröder FH, Par...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF