Advanced imaging of prostate with 4-D ultrasound in suspected cases of prostate cancer: a randomised prospective study

ISRCTN	ISRCTN39058446
DOI	https://doi.org/10.1186/ISRCTN39058446
Protocol serial number	N0024108495
Sponsor	Department of Health (UK)
Funder	Homerton University Hospital NHS Trust (UK)

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

Mr Vinod Nargund
Scientific

Department of Urology
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 020 8510 7522
Email	vinod.nargund@homerton.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The use of real time 3-D (4-D ultrasound) guided transrectal biopsy of prostate improves sensitivity and specificity in identifying potential malignant foci in prostate gland compared to conventional 2-D ultrasonography.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Prostate
Intervention	1.. 4-D ultrasound 2. Standard care July 2008: trial not started.
Intervention type	Other
Primary outcome measure(s)	1. Total PSA prostate volume 2. Volume of the tumour 3. PSA Density: PSA X volume 4. Histology of the cores: Gleason grading 5. Doppler findings: Pulsatility index, peak systolic volume, resistance index, flow velocity
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/2004
Reason abandoned (if study stopped)	Not started because of lack of funding

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	60
Key inclusion criteria	1. Patients with suspected carcinoma of the prostate, ie raised prostate specific antigen (PSA) 2. Age group 45-70 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2002
Date of final enrolment	31/01/2004

Department of Urology

London
E9 6SR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan