A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate
RCT
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 29, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedMay 6, 2014
May 1, 2014
1.9 years
April 29, 2013
May 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the rate of positive detections
1year
Secondary Outcomes (1)
the incidence rate of each complication
1 year
Other Outcomes (1)
pain level assessed by visual analogue scale
1 year
Study Arms (2)
trans-rectal
EXPERIMENTALtrans-rectal to perform the prostate biopsy
trans-perineal
EXPERIMENTALtrans-perineal to perform the prostate biopsy
Interventions
the puncture points are at the rectal
the puncture points are at the perineal
Eligibility Criteria
You may qualify if:
- prostate-specific antigen \> 4ng/ml
- Palpation is positive
You may not qualify if:
- older than 80y
- prostate-specific antigen \> 100 ng/ml
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
10Th Hospital of Tongji University
Shanghai, Shanghai Municipality, 200072, China
Related Publications (1)
Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate
BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2013
First Posted
May 9, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Last Updated
May 6, 2014
Record last verified: 2014-05