ComplicationRCTNCT01849835
A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate
A study testing trans-rectal to perform the prostate biopsy and trans-perineal to perform the prostate biopsy in people with Complication, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years, men only
- Conditions the study is for
- Complication
- What is being tested?
- trans-rectal to perform the prostate biopsy and trans-perineal to perform the prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- prostate-specific antigen > 4ng/ml
- Palpation is positive
Who cannot join
- older than 80y
- prostate-specific antigen > 100 ng/ml
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
10Th Hospital of Tongji University
Shanghai, Shanghai Municipality, 200072
guo lehang, phd, +8613764538305, gopp1314@hotmail.com
xu huixiong, phd
About this study
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.
- Conditions
- Complication
- Being tested
- trans-rectal to perform the prostate biopsy, trans-perineal to perform the prostate biopsy
- Keywords
- rate of positive detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-rectal to perform the prostate biopsyProcedure or surgery
the puncture points are at the rectal
trans-perineal to perform the prostate biopsyProcedure or surgery
Also called the puncture points are at the perineal
the puncture points are at the perineal
| Study group | Role | What they receive |
|---|---|---|
| trans-rectal | Experimental | trans-rectal to perform the prostate biopsy Receives: Procedure: trans-rectal to perform the prostate biopsy |
| trans-perineal | Experimental | trans-perineal to perform the prostate biopsy Receives: Procedure: trans-perineal to perform the prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of positive detections
Measured: 1year
Secondary outcomes (1)
the incidence rate of each complication
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le-hang Guo, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849835
- Sponsor's protocol ID
- tongji10us
- Other IDs
- tongji10-us1
- Acronym
- RCT
- Status last verified
- May 2014
- First submitted
- 29 Apr 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate
- ClinicalTrials.gov ID
- NCT01849835
- Acronym / sponsor ID
- RCT / tongji10us
- Conditions
- Complication
- Keywords
- rate of positive detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-rectal | Experimental | Procedure: trans-rectal to perform the prostate biopsytrans-rectal to perform the prostate biopsy |
| trans-perineal | Experimental | Procedure: trans-perineal to perform the prostate biopsytrans-perineal to perform the prostate biopsy |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- prostate-specific antigen > 4ng/ml
- Palpation is positive
Key exclusion criteria (2 listed)
- older than 80y
- prostate-specific antigen > 100 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trans-rectal to perform the prostate biopsythe puncture points are at the rectal | Procedure or surgery | trans-rectal |
| trans-perineal to perform the prostate biopsyAlso: the puncture points are at the perinealthe puncture points are at the perineal | Procedure or surgery | trans-perineal |
Primary outcome
the rate of positive detections
Time frame: 1year
1 secondary outcome
the incidence rate of each complication
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- BackgroundEvidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-rectal to perform the prostate biopsy and trans-perineal to perform the prostate biopsy in people with Complication, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact guo lehang, phd (+8613764538305, gopp1314@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of positive detections (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.