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
Scientific
Vasco de Quiroga 15
Col. Seccion XVI
Tlalpan
Mexico City
14000
Mexico
| frodriguez.covarrubias@gmail.com |
Study information
| Study design | Single centre prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/01/2009 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 150 participants, randomly assigned to study group (75 patients) or control group (75 patients) |
| 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
14000
Mexico
Sponsor information
Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)
Research organisation
Research organisation
Vasco de Quiroga 15
Col. Seccion XVI
Tlalpan
Mexico City
14000
Mexico
| francisco.rodriguezc@quetzal.innsz.mx | |
"ROR" |
https://ror.org/00xgvev73 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
