Prostate CancerNCT05179720
The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
A study testing puncture stent-assisted transperineal prostate biopsy in people with Prostate Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- puncture stent-assisted transperineal prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected prostate cancer patients Can tolerate prostate puncture
Who cannot join
- Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital
Jinan, Shandong, 276600
shouzhen chen, 18560089085, Jiangxin98@mail.sdu.edu.cn
About this study
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy
Read the detailed description
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time
- Conditions
- Prostate Cancer
- Being tested
- puncture stent-assisted transperineal prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
puncture stent-assisted transperineal prostate biopsyOther
Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| puncture stent-assisted transperineal prostate biopsy | Experimental | This group of patients underwent puncture stent-assisted transperineal prostate biopsy. Receives: Other: puncture stent-assisted transperineal prostate biopsy |
| transperineal free-hand biopsy | Active comparator | This group of patients underwent perineal free-hand biopsy Receives: Other: puncture stent-assisted transperineal prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive rate of biopsy
Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer
Measured: 1 year
Secondary outcomes (3)
Biopsy complications include (infection, bleeding, etc.)
Biopsy complications include (infection, bleeding, etc.)
Measured: 1 year
Pain score of biopsy patients (NRS score)
Pain score of biopsy patients (NRS score)
Measured: 1 year
Biopsy time
Biopsy time
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 posted5 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Model description
- Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179720
- Sponsor's protocol ID
- CSZ02
- Status last verified
- Jan 2022
- First submitted
- 1 Dec 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT05179720
- Acronym / sponsor ID
- CSZ02
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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.
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy
Detailed description
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
| Arm | Type | Receives |
|---|---|---|
| puncture stent-assisted transperineal prostate biopsy | Experimental | Other: puncture stent-assisted transperineal prostate biopsyThis group of patients underwent puncture stent-assisted transperineal prostate biopsy. |
| transperineal free-hand biopsy | Active comparator | Other: puncture stent-assisted transperineal prostate biopsyThis group of patients underwent perineal free-hand biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected prostate cancer patients Can tolerate prostate puncture
Key exclusion criteria (1 listed)
- Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
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 |
|---|---|---|
| puncture stent-assisted transperineal prostate biopsyPatients in the experimental group used a puncture stent to assist transperineal prostate biopsy | Other | puncture stent-assisted transperineal prostate biopsy, transperineal free-hand biopsy |
Primary outcome
positive rate of biopsy
Time frame: 1 year
Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer
3 secondary outcomes
Biopsy complications include (infection, bleeding, etc.)
Time frame: 1 year
Pain score of biopsy patients (NRS score)
Time frame: 1 year
Biopsy time
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 18 Oct 2022.
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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 puncture stent-assisted transperineal prostate biopsy in people with Prostate Cancer, run by Qilu Hospital of Shandong University 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 1 inclusion and 1 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 18 Oct 2022. 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 Shouzhen Chen, Dr. (18560089085, chensz@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive rate of biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.