Prostate CancerNCT06482658
Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer
A study testing Transrectal perilesional/regional systematic biopsy (PB/RSB) and Combination of transrectal systematic biopsy and targeted biopsy in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal 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?
- Transrectal perilesional/regional systematic biopsy (PB/RSB) and Combination of transrectal systematic biopsy and targeted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 30 Nov 2024
- 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 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 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 ≥ 4.
- 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 < 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.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety Evaluation of Transrectal Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
The goal of this single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Read more
Does transrectal PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of transrectal prostate biopsy? Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of TB+SB to explore the efficacy of different transrectal prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive transrectal PB/RSB 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 multiparametric magnetic resonance imaging (mpMRI). 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, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.
Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive transrectal PB/RSB or TB+SB.
- Conditions
- Prostate Cancer
- Being tested
- Transrectal perilesional/regional systematic biopsy (PB/RSB), Combination of transrectal systematic biopsy and targeted biopsy
- Keywords
- Prostate cancer, Randomized controlled trial, Transrectal perilesional biopsy, Transrectal regional systematic 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.
Transrectal perilesional/regional systematic biopsy (PB/RSB)Procedure 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. 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 obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion.
Combination of transrectal systematic biopsy and targeted biopsyProcedure 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. 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. Three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal perilesional/regional systematic biopsy (PB/RSB) group | Experimental | For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion. Receives: Procedure: Transrectal perilesional/regional systematic biopsy (PB/RSB) |
| Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group | Experimental | For patients in the TB+SB group, three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy. Receives: Procedure: Combination of transrectal systematic biopsy and targeted biopsy |
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 PB/RSB 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 (7)
The overall complication rate
The complication (mainly including bleeding, infection, pain, and lower urinary tract symptoms) rate after the prostate biopsy (PB/RSB or TB+SB).
Measured: 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 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 PB/RSB and combination of TB+SB.
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 Gleason score (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 posted1 Jul 2024
- Study start12 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 380 participants (actual)
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
- NCT06482658
- Sponsor's protocol ID
- PB-02
- Status last verified
- Dec 2024
- First submitted
- 25 Jun 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng R, Li D, Wu J, Tian S, Shen Q, Hu S, Shang M, Qiu J, Shang J, Zhou J, Cai L, Liu Y, Gong K. Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naive Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial. J Urol. 2026 Apr;215(4):408-420. doi: 10.1097/JU.0000000000004863. Epub 2025 Nov 21.
PubMed 41270377
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Transrectal Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06482658
- Acronym / sponsor ID
- PB-02
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Randomized controlled trial, Transrectal perilesional biopsy, Transrectal regional systematic biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- 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 single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does transrectal PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of transrectal prostate biopsy? Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of TB+SB to explore the efficacy of different transrectal prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive transrectal PB/RSB 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 multiparametric magnetic resonance imaging (mpMRI). 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, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.
Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life.
Participants will:
Receive transrectal PB/RSB or TB+SB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal perilesional/regional systematic biopsy (PB/RSB) group | Experimental | Procedure: Transrectal perilesional/regional systematic biopsy (PB/RSB)For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion. |
| Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group | Experimental | Procedure: Combination of transrectal systematic biopsy and targeted biopsyFor patients in the TB+SB group, three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy. |
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.
- 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 ≥ 4.
- 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 < 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 |
|---|---|---|
| Transrectal perilesional/regional systematic biopsy (PB/RSB)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. 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 obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion. | Procedure or surgery | Transrectal perilesional/regional systematic biopsy (PB/RSB) group |
| Combination of transrectal systematic biopsy and targeted biopsyThe 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. 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. Three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy. | Procedure or surgery | Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group |
Primary outcome
The clinically significant prostate cancer (csPCa) detection rate for PB/RSB 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.
7 secondary outcomes
The overall complication rate
Time frame: One month after the biopsy procedure.
The self-reported quality of life after the prostate biopsy
Time frame: 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 Gleason score (GS) of radical prostatectomy (RP) specimens
Time frame: One month after the biopsy procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 41270377Deng R, Li D, Wu J, Tian S, Shen Q, Hu S, Shang M, Qiu J, Shang J, Zhou J, Cai L, Liu Y, Gong K. Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naive Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial. J Urol. 2026 Apr;215(4):408-420. doi: 10.1097/JU.0000000000004863. Epub 2025 Nov 21.
- Individual participant dataSharing planned: No
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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.
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 Transrectal perilesional/regional systematic biopsy (PB/RSB) and Combination of transrectal systematic biopsy and targeted biopsy 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: finished, as of the sponsor's last update on 8 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinically significant prostate cancer (csPCa) detection rate for PB/RSB 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?
On the ClinicalTrials.gov record for NCT06482658, 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 8 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.