Contact information
Type
Scientific
Primary contact
Dr Francisco Rodriguez-Covarrubias
ORCID ID
Contact details
Vasco de Quiroga 15
Col. Seccion XVI
Tlalpan
Mexico City
14000
Mexico
frodriguez.covarrubias@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of 12-core versus 18-core biopsy in transrectal ultrasound-guided prostate biopsy for prostate cancer diagnosis: a randomised controlled trial
Acronym
Study hypothesis
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
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)
Study design
Single centre prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Prostate cancer detection rate
Secondary outcome measures
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
Overall trial start date
01/01/2009
Overall trial end date
31/01/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
150 participants, randomly assigned to study group (75 patients) or control group (75 patients)
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
31/01/2010
Locations
Countries of recruitment
Mexico
Trial participating centre
Vasco de Quiroga 15
Mexico City
14000
Mexico
Sponsor information
Organisation
Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)
Sponsor details
Vasco de Quiroga 15
Col. Seccion XVI
Tlalpan
Mexico City
14000
Mexico
francisco.rodriguezc@quetzal.innsz.mx
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary