Comparison of 12-core versus 18-core biopsy in transrectal ultrasound-guided prostate biopsy for prostate cancer diagnosis

ISRCTN	ISRCTN65812524
DOI	https://doi.org/10.1186/ISRCTN65812524
Protocol serial number	N/A
Sponsor	Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)
Funder	Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)

Submission date: 26/08/2010
Registration date: 06/09/2010
Last edited: 06/09/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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

Contact information

Dr Francisco Rodriguez-Covarrubias
Scientific

Vasco de Quiroga 15
Col. Seccion XVI
Tlalpan
Mexico City
14000
Mexico

Email	frodriguez.covarrubias@gmail.com

Study information

Primary study design	Interventional
Study design	Single centre prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of 12-core versus 18-core biopsy in transrectal ultrasound-guided prostate biopsy for prostate cancer diagnosis: a randomised controlled trial
Study objectives	Increasing the number of cores from 12 to 18 during transrectal ultrasound-guided prostate biopsy will improve cancer detection rate of this diagnostic procedure.
Ethics approval(s)	The Institutional Committee of Biomedical Investigation in Humans of the Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) approved on the 18th of December 2008 (ref: 1940)
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	Patients undergoing transrectal ultrasound-guided prostate biopsy will be randomised to: 1. Study group: 18-core biopsy 2. Control group: 12-core biopsy All procedures performed under mild intravenous sedation, outpatient basis.
Intervention type	Other
Primary outcome measure(s)	Prostate cancer detection rate
Key secondary outcome measure(s)	1. Detection of 'clinically insignificant' prostate cancer 2. Comparison of pain through visual analog scale (VAS) between groups at baseline and 7 days after the procedure with a questionnaire 3. Complication rate evaluation in both groups at baseline and 7 days after the procedure with a questionnaire
Completion date	31/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	150
Key inclusion criteria	1. Male patients 2. Age 45 to 75 years old 3. Prostate-specific antigen ranging from 4 to 20 ng/ml and/or suspicious digital rectal examination, requiring transrectal ultrasound-guided prostate biopsy for the first time
Key exclusion criteria	1. Previous prostate cancer diagnosis 2. Previous prostate surgery 3. Previous prostate biopsy 4. Prostate-specific antigen above 20 ng/ml 5. Previous intake of 5-alfa reductase inhibitors (finasteride or dutasteride) 6. Previous intake or use of hormonal therapy
Date of first enrolment	01/01/2009
Date of final enrolment	31/01/2010

Locations

Countries of recruitment

Mexico

Study participating centre

Vasco de Quiroga 15

Mexico City
14000
Mexico

Results and Publications

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

Study outputs

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