A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate

Not Applicable

• Conditions: Complication
• Interventions: Procedure: trans-rectal to perform the prostate biopsy; Procedure: trans-perineal to perform the prostate biopsy

• Registration Number: NCT01849835
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-04
• Last Update Posted: 2014-05-06
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• prostate-specific antigen > 4ng/ml
• Palpation is positive

Exclusion Criteria

• older than 80y
• prostate-specific antigen > 100 ng/ml

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trans-rectal	trans-rectal to perform the prostate biopsy	trans-rectal to perform the prostate biopsy
trans-perineal	trans-perineal to perform the prostate biopsy	trans-perineal to perform the prostate biopsy

Primary Outcome Measures

Name	Time	Method
the rate of positive detections	1year

Secondary Outcome Measures

Name	Time	Method
the incidence rate of each complication	1 year

Trial Locations

Locations (1)

10Th Hospital of Tongji University; 🇨🇳 Shanghai, Shanghai, China