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

Tongji University

Status: Unknown

Conditions: Complication

Treatments: Procedure: trans-perineal to perform the prostate biopsy; Procedure: trans-rectal to perform the prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01849835

tongji10-us1

tongji10us

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

trans-rectal

Experimental group

Description:

trans-rectal to perform the prostate biopsy

Treatment:

Procedure: trans-rectal to perform the prostate biopsy

trans-perineal

Experimental group

Description:

trans-perineal to perform the prostate biopsy

Treatment:

Procedure: trans-perineal to perform the prostate biopsy