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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Shanghai 10th People's Hospital
Sponsor:
Information provided by (Responsible Party):
Le-hang Guo, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT01849835
First received: April 29, 2013
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Complication
Procedure: trans-rectal to perform the prostate biopsy
Procedure: trans-perineal to perform the prostate biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • the rate of positive detections [ Time Frame: 1year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence rate of each complication [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • pain level assessed by visual analogue scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trans-rectal
trans-rectal to perform the prostate biopsy
Procedure: trans-rectal to perform the prostate biopsy
the puncture points are at the rectal
Experimental: trans-perineal
trans-perineal to perform the prostate biopsy
Procedure: trans-perineal to perform the prostate biopsy
the puncture points are at the perineal
Other Name: the puncture points are at the perineal

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • older than 80y
  • prostate-specific antigen > 100 ng/ml
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849835

Contacts
Contact: guo lehang, phd +8613764538305 gopp1314@hotmail.com

Locations
China, Shanghai
10Th Hospital of Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: guo lehang, phd    +8613764538305    gopp1314@hotmail.com   
Principal Investigator: xu huixiong, phd         
Sponsors and Collaborators
Shanghai 10th People's Hospital
  More Information

No publications provided

Responsible Party: Le-hang Guo, Principal Investigator, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01849835     History of Changes
Other Study ID Numbers: tongji10us, tongji10-us1
Study First Received: April 29, 2013
Last Updated: May 4, 2014
Health Authority: China: Ministry of Health

Keywords provided by Shanghai 10th People's Hospital:
rate of positive detection

Additional relevant MeSH terms:
Menthol
Antipruritics
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014