Prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
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 intravenou
Sponsors
Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate cancer detection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mexico
Outcome results
None listed