Comparison of 12-core versus 18-core biopsy in transrectal ultrasound-guided prostate biopsy for prostate cancer diagnosis

Completed

• Conditions: Cancer; Malignant neoplasm of prostate; Prostate cancer

• Registration Number: ISRCTN65812524
• Lead Sponsor: Salvador Zubiran National Institute of Nutrition (Instituto Nacional de la Nutricion Salvador Zubiran) (Mexico)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate cancer detection rate

Secondary Outcome Measures

Name	Time	Method
1. Detection of 'clinically insignificant' prostate cancer<br>2. Comparison of pain through visual analog scale (VAS) between groups at baseline and 7 days after the procedure with a questionnaire<br>3. Complication rate evaluation in both groups at baseline and 7 days after the procedure with a questionnaire