Condition category
Cancer
Date applied
26/08/2010
Date assigned
06/09/2010
Last edited
06/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes