Prostate CancerNCT06482645
Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
A study testing TB+PB and TB+SB in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB). 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?
- TB+PB and TB+SB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Jul 2027
- 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.
- No previous biopsy.
- Patients with single suspicious lesion, complete MRI 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 MRI examination should not exceed one month.
- PSA<50ng/mL.
- Patients with complete clinical information.
Who cannot join
- The MRI data was unqualified or incomplete.
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
- Patients with previous biopsy.
- Patients with PI-RADS V2.1 of < 4.
- 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
Baowei Zhang, +86 83572466, bdyyll@126.com
About this study
Official title: Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
Read the detailed description
Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on magnetic resonance imaging (MRI). Although the combined biopsy 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 omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the PB schemes. Thus, this multicenter randomized controlled trial (RCT) aims to evaluate the efficacy of TB+PB schemes and the routine TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of csPCa? What is the value of PB in improving the safety of prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of TB+PB and TB+SB. Participants were prospectively enrolled and were randomly allocated to TB+PB group and TB+SB group.
Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
- Conditions
- Prostate Cancer
- Being tested
- TB+PB, TB+SB
- Keywords
- Prostate cancer, Multicenter randomized controlled trial, Perilesional 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.
TB+PBProcedure or surgery
The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.
TB+SBProcedure or surgery
The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.
| Study group | Role | What they receive |
|---|---|---|
| TB+PB group | Experimental | For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion. Receives: Procedure: TB+PB |
| TB+SB group | Experimental | For patients in the TB+SB group, TB cores were obtained from the lesion, followed by 12-core SB. Receives: Procedure: TB+SB |
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 for TB+PB and TB+SB
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 (4)
The PCa detection rate
The PCa detection rate for TB+PB and TB+SB.
Measured: One month after the biopsy procedure.
The high-grade PCa detection rate
The high-grade PCa was defined as PCa with a grade group ≥3 or GS≥4+3. The reference standard was the pathological result.
Measured: One month after the biopsy procedure.
The clinically insignificant PCa (ciPCa) detection rate
The ciPCa was defined as PCa with a grade group <2 or GS <3+4. 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Beijing Friendship Hospital, Chinese People's Liberation Army (PLA) General Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-Sen University Cancer Center
- 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
- NCT06482645
- Sponsor's protocol ID
- PB-01
- Status last verified
- Nov 2026
- First submitted
- 25 Jun 2024
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06482645
- Acronym / sponsor ID
- PB-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Multicenter randomized controlled trial, Perilesional biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Beijing Friendship Hospital, Chinese People's Liberation Army (PLA) General Hospital, Zhejiang Cancer Hospital, First Affiliated Hospital of Chongqing Medical University, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-Sen University Cancer Center
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Jul 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 multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
Detailed description
Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on magnetic resonance imaging (MRI). Although the combined biopsy 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 omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the PB schemes. Thus, this multicenter randomized controlled trial (RCT) aims to evaluate the efficacy of TB+PB schemes and the routine TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of csPCa? What is the value of PB in improving the safety of prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of TB+PB and TB+SB. Participants were prospectively enrolled and were randomly allocated to TB+PB group and TB+SB group.
Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB+PB group | Experimental | Procedure: TB+PBFor each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion. |
| TB+SB group | Experimental | Procedure: TB+SBFor patients in the TB+SB group, TB cores were obtained from the lesion, followed by 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 (7 listed)
- The age of the patient is between 45 and 85.
- No previous biopsy.
- Patients with single suspicious lesion, complete MRI 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 MRI examination should not exceed one month.
Key exclusion criteria (8 listed)
- The MRI data was unqualified or incomplete.
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
- Patients with previous biopsy.
- Patients with PI-RADS V2.1 of < 4.
- 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 |
|---|---|---|
| TB+PBThe biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion. | Procedure or surgery | TB+PB group |
| TB+SBThe biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB. | Procedure or surgery | TB+SB group |
Primary outcome
The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+SB
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.
4 secondary outcomes
The PCa detection rate
Time frame: One month after the biopsy procedure.
The high-grade PCa detection rate
Time frame: One month after the biopsy procedure.
The clinically insignificant PCa (ciPCa) 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.
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 3 Nov 2026.
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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 TB+PB and TB+SB 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 7 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 3 Nov 2026. 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 for TB+PB and TB+SB (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 3 Nov 2026.