Prostate CancerNCT06684652
Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer
A study testing 3TB+6SB and 3TB+12SB in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB). Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 3TB+6SB and 3TB+12SB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the patient is between 45 and 85 years.
- No previous biopsy.
- Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
- Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.
- The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
- Patients with complete clinical information.
Who cannot join
- The mpMRI data was unqualified or incomplete.
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
- Patients with previous biopsy.
- Patients with PI-RADS V2.1 of < 3.
- Patients were not in accordance with the indication of prostate biopsy.
- The patient could not cooperate to complete the prostate biopsy.
- The patients or their family members refused to participate in this study.
- Patients with incomplete clinical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yi Liu, +86 13611035261, liuyipkuhsc@163.com
Ruiyi Deng, +86 13307720043, 1910301104@pku.edu.cn
About this study
Official title: Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB).
The main questions it aims to answer are:
Read more
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive 3TB+6SB or 3TB+12SB.
Read the detailed description
Currently, combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the 3TB+12SB approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be reduced when the chance of missing a clinically significant lesion is low. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Some retrospective studies have proved that the cancer detection rate of targeted biopsy plus sextant biopsy (3TB+6SB) was not inferior to 3TB+12SB. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the 3TB+6SB schemes. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy and safety of 3TB+6SB schemes and the routine 3TB+12SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of 3TB+6SB in improving the safety of prostate biopsy? This prospective RCT compared the csPCa detection rates of 3TB+6SB and 3TB+12SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from September 2024 to February 2025. Participants were randomly allocated to 3TB+6SB group and 3TB+12SB group.
Researchers will compare the cancer detection rates of 3TB+6SB and 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
- Conditions
- Prostate Cancer
- Being tested
- 3TB+6SB, 3TB+12SB
- Keywords
- Prostate cancer, Randomized controlled trial, Targeted biopsy, Systematic biopsy, Sextant 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.
3TB+6SBProcedure or surgery
The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.
3TB+12SBProcedure or surgery
The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.
| Study group | Role | What they receive |
|---|---|---|
| 3TB+6SB group | Experimental | For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Receives: Procedure: 3TB+6SB |
| 3TB+12SB group | Experimental | For patients in the 3TB+12SB group, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Receives: Procedure: 3TB+12SB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinically significant prostate cancer (csPCa) detection rate
csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological result.
Measured: One month after the biopsy procedure.
Secondary outcomes (7)
The overall complication rate
The complication (mainly including bleeding, infection, pain, and lower urinary tract symptoms) rate after the prostate biopsy (3TB+6SB or 3TB+12SB).
Measured: One week and one month after the biopsy procedure.
The self-reported quality of life after the prostate biopsy
The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort.
Measured: One week and one month after the biopsy procedure.
The operation time of prostate biopsy
The operation time of prostate biopsy was defined as the time from the beginning to the end of the prostate biopsy.
Measured: During the prostate biopsy procedure.
The PCa detection rate
The PCa detection rate for 3TB+6SB and 3TB+12SB.
Measured: One month after the biopsy procedure.
The clinically insignificant PCa detection rate
The clinically insignificant PCa was defined as PCa with a grade group < 2 or GS < 7. The reference standard was the pathological result.
Measured: One month after the biopsy procedure.
The Gleason score (GS) of the biopsy sample
The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.
Measured: One month after the biopsy procedure.
The GS of radical prostatectomy (RP) specimens
For the RP specimens, the Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.
Measured: One month after the biopsy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (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 Peking University First HospitalThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU Yi, Peking University First Hospital
- Investigators
- Yi Liu, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684652
- Sponsor's protocol ID
- TB+6SB_01
- Status last verified
- Jun 2025
- First submitted
- 10 Nov 2024
- Last updated
- 13 Jun 2025
- 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 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06684652
- Acronym / sponsor ID
- TB+6SB_01
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Randomized controlled trial, Targeted biopsy, Systematic biopsy, Sextant biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB).
The main questions it aims to answer are:
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive 3TB+6SB or 3TB+12SB.
Detailed description
Currently, combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the 3TB+12SB approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be reduced when the chance of missing a clinically significant lesion is low. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Some retrospective studies have proved that the cancer detection rate of targeted biopsy plus sextant biopsy (3TB+6SB) was not inferior to 3TB+12SB. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the 3TB+6SB schemes. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy and safety of 3TB+6SB schemes and the routine 3TB+12SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of 3TB+6SB in improving the safety of prostate biopsy? This prospective RCT compared the csPCa detection rates of 3TB+6SB and 3TB+12SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from September 2024 to February 2025. Participants were randomly allocated to 3TB+6SB group and 3TB+12SB group.
Researchers will compare the cancer detection rates of 3TB+6SB and 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3TB+6SB group | Experimental | Procedure: 3TB+6SBFor each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. |
| 3TB+12SB group | Experimental | Procedure: 3TB+12SBFor patients in the 3TB+12SB group, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age of the patient is between 45 and 85 years.
- No previous biopsy.
- Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
- Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.
- The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate mpMRI examination should not exceed one month.
Key exclusion criteria (8 listed)
- The mpMRI data was unqualified or incomplete.
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
- Patients with previous biopsy.
- Patients with PI-RADS V2.1 of < 3.
- Patients were not in accordance with the indication of prostate biopsy.
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 |
|---|---|---|
| 3TB+6SBThe biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings. | Procedure or surgery | 3TB+6SB group |
| 3TB+12SBThe biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. Urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings. | Procedure or surgery | 3TB+12SB group |
Primary outcome
The clinically significant prostate cancer (csPCa) detection rate
Time frame: One month after the biopsy procedure.
csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological result.
7 secondary outcomes
The overall complication rate
Time frame: One week and one month after the biopsy procedure.
The self-reported quality of life after the prostate biopsy
Time frame: One week and one month after the biopsy procedure.
The operation time of prostate biopsy
Time frame: During the prostate biopsy procedure.
The PCa detection rate
Time frame: One month after the biopsy procedure.
The clinically insignificant PCa detection rate
Time frame: One month after the biopsy procedure.
The Gleason score (GS) of the biopsy sample
Time frame: One month after the biopsy procedure.
The GS of radical prostatectomy (RP) specimens
Time frame: One month after the biopsy procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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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.
Yi Liu principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3TB+6SB and 3TB+12SB in people with Prostate Cancer, run by Peking University First 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Liu (+86 13611035261, liuyipkuhsc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinically significant prostate cancer (csPCa) detection rate (time frame: One month after the biopsy procedure.). 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 13 Jun 2025.