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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) ?
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?
Secondary ID [1] 281100 0
Nil
Universal Trial Number (UTN)
U1111-1133-8530
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 287258 0
Condition category
Condition code
Cancer 287585 287585 0 0
Prostate

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 285554 0
Diagnosis / Prognosis
Intervention code [2] 285561 0
Early detection / Screening
Comparator / control treatment
TRUS-guided biopsies of the prostate.
Control group
Active

Outcomes
Primary outcome [1] 287845 0
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
Timepoint [1] 287845 0
At conclusion of study
Primary outcome [2] 287846 0
2. Analysis of the number of biopsy cores taken to achieve diagnosis
Timepoint [2] 287846 0
At conclusion of study
Primary outcome [3] 287847 0
3. Assess the detection or exclusion of indolent (insignificant) cancer by mpMRI and biopsy vs TRUS guided biopsy
Timepoint [3] 287847 0
At conclusion of study
Secondary outcome [1] 298930 0
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
Timepoint [1] 298930 0
At conclusion of study

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.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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)

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)
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
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
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285886 0
Hospital
Name [1] 285886 0
The Wesley Hospital
Country [1] 285886 0
Australia
Funding source category [2] 285888 0
Other
Name [2] 285888 0
Wesley Research Institute
Country [2] 285888 0
Australia
Primary sponsor type
Hospital
Name
The Wesley Hospital
Address
451 Coronation Drive
Auchenflower QLD 4066
Country
Australia
Secondary sponsor category [1] 284711 0
Other
Name [1] 284711 0
The Wesley Research Institute
Address [1] 284711 0
Level 8, East Wing
The Wesley Hospital
451 Coronation Drive
Auchenflower QLD 4066
Country [1] 284711 0
Australia
Other collaborator category [1] 277044 0
Hospital
Name [1] 277044 0
St Radbound University Hospital
Address [1] 277044 0
St Radbound University Hospital
6525 GA Nijmegen
Country [1] 277044 0
Netherlands
Other collaborator category [2] 277045 0
University
Name [2] 277045 0
The University of Queensland
Address [2] 277045 0
Queensland Clinical Trials & Biostatistics Centre
School of Population Health, University of Queensland
Level 1, Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country [2] 277045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287915 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [1] 287915 0
Ethics committee country [1] 287915 0
Australia
Date submitted for ethics approval [1] 287915 0
Approval date [1] 287915 0
28/05/2012
Ethics approval number [1] 287915 0
1211

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

Contacts
Principal investigator
Name 34626 0
Address 34626 0
Country 34626 0
Phone 34626 0
Fax 34626 0
Email 34626 0
Contact person for public queries
Name 17873 0
Dr Leslie C Thompson
Address 17873 0
Suite 14
Level 1
Wesley Medical Centre
40 Chasely St
Auchenflower
QLD 4066
Country 17873 0
Australia
Phone 17873 0
+61 7 3371 7728
Fax 17873 0
Email 17873 0
[email protected]
Contact person for scientific queries
Name 8801 0
Dr Leslie C Thompson
Address 8801 0
Suite 14
Level 1
Wesley Medical Centre
40 Chasely St
Auchenflower
QLD 4066
Country 8801 0
Australia
Phone 8801 0
+61 7 3371 7728
Fax 8801 0
Email 8801 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

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Pokorny MR, de Rooij M, Duncan E, Schröder FH, Par... [More Details]

Documents added automatically
No additional documents have been identified.