Study of topical glyceryl trinitrate and tolerance of transrectal ultrasound-guided prostate biopsy (TRUS biopsy).

ISRCTN	ISRCTN49593371
DOI	https://doi.org/10.1186/ISRCTN49593371
Protocol serial number	N0176127662
Sponsor	Department of Health
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Simon F Brewster
Scientific

Department of Urology
Churchill Hospital
Churchill Drive
Headington
Oxford
OX3 7LJ
United Kingdom

Phone	+44 (0)1865 225717

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	TRUS biopsy is the technique of choice for the diagnosis of carcinoma of the prostate (CaP), particularly for early stage tumours. The number of procedures is likely to escalate in the future. The procedure is performed in an outpatient setting without sedation, and without topical analgesia. However, many patients regard the uncomfortable nature of anal distension on the introduction of the rectal ultrasound probe as the most distressing feature of the procedure, and we hope that this can be alleviated with topical GTN (topical glyceryl trinitrate) paste. Patients will either complete the study by undergoing biopsy with GTN or control paste or withdraw and require inhaled nitrous oxide/general anaesthetic. We hope to recruit 100 patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Prostate
Intervention	Glyceryl trinitrate (GTN) or control paste
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	topical glyceryl trinitrate
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	100
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2003
Date of final enrolment	01/05/2004

Department of Urology

Oxford
OX3 7LJ
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?
Results article	results	01/02/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes