The effect of magnetic resonance imaging localisation of prostate cancer on transrectal ultrasound biopsy detection rate

ISRCTN	ISRCTN28276837
DOI	https://doi.org/10.1186/ISRCTN28276837
Secondary identifying numbers	N0436146607

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Miss S Jervis
Scientific

Medical Physics
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 6495
Email	r&d@leedsth.nhs.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The effect of magnetic resonance imaging localisation of prostate cancer on transrectal ultrasound biopsy detection rate
Study objectives	To investigate whether localisation information from magnetic resonance imaging (MRI) can be used to improve the accuracy of trans-rectal ultrasound (TRUS) biopsy and thereby improve the detection rate of prostate cancer.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Randomised controlled trial
Intervention type	Other
Primary outcome measure	Percentage of patients with at least one positive biopsy in each cohort
Secondary outcome measures	Not provided at time of registration
Overall study start date	09/02/2004
Completion date	01/08/2005

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	122
Key inclusion criteria	All patients who are to have a transrectal ultrasound (TRUS) biopsy (on a Thursday) to confirm prostate cancer, with an intermediate PSA level (10-19 ng/ml), will be eligible for entry to the study. On average 8 patients undergo TRUS biopsy at Cookridge Hospital per week (divided between Tuesday and Thursday morning sessions). One MRI slot per week (Thursday morning) will be available for the study. All consenting patients will be randomised and one selected for the MRI cohort and all others will form the non-MRI cohort. Assuming at least 2 patients are recruited a week (50%) recruitment rate) the two cohorts (61 patients in each) will be recruited in 61 weeks.
Key exclusion criteria	1. Unwilling/unable to give informed consent 2. Significant claustrophobia 3. Contra indications to MRI: pacemaker, aneurysm clips, metallic foreign bodies in the eye
Date of first enrolment	09/02/2004
Date of final enrolment	01/08/2005

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

05/02/2018: No publications found, verifying study status with principal investigator.