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
Secondary identifying numbers N/A
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

frodriguez.covarrubias@gmail.com

Study information

Study designSingle centre prospective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleComparison of 12-core versus 18-core biopsy in transrectal ultrasound-guided prostate biopsy for prostate cancer diagnosis: a randomised controlled trial
Study objectivesIncreasing 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) studiedProstate cancer
InterventionPatients 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 typeOther
Primary outcome measureProstate cancer detection rate
Secondary outcome measures1. 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 study start date01/01/2009
Completion date31/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants150 participants, randomly assigned to study group (75 patients) or control group (75 patients)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2009
Date of final enrolment31/01/2010

Locations

Countries of recruitment

  • Mexico

Study participating centre

Vasco de Quiroga 15
Mexico City
14000
Mexico

Sponsor information

Funders

Funder type

Research organisation

Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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