The effect of needle thickness on the diagnosis of prostate cancer

ISRCTN	ISRCTN98984328
DOI	https://doi.org/10.1186/ISRCTN98984328
Protocol serial number	N0280190231
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Wirral Hospitals NHS Trust

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 Rahul Mistry
Scientific

Urology Dept, Ward M2
Clatterbridge Hospital
Clatterbridge Road
Bebington
Wirral
CH63 4JY
United Kingdom

Phone	+44 (0)7967339014
Email	rahulmistry1@hotmail.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of needle thickness on the diagnosis of prostate cancer
Study objectives	1. To determine if using smaller needles to biopsy the prostate provides tissue that is equally accurate for histopathological examination. 2. To analyse the post-operative pain perception following local anaesthetic infiltration or sedation prostrate biopsies. 3. To determine if there are any post-operative complications or erectile dysfunction following prostrate biopsies.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Prostate
Intervention	Double blind binary randomization to either large needle TRUS biopsy or small needle TRUS biopsy.
Intervention type	Other
Primary outcome measure(s)	1. Pre-op erectile dysfunction questionnaire 2. Post-op pain evaluation 3. Complication & ED questionnaire 4. Prostate histopathology
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	100
Key inclusion criteria	75-100 consecutive men undergoing TRUS prostate biopsies for investigation into a raised PSA level &/or an abnormal digital rectal examination (DRE)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2006
Date of final enrolment	01/12/2007

Clatterbridge Hospital

Wirral
CH63 4JY
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

12/10/2017: No publications found, verifying study status with principal investigator.