Prostate CancerNCT06392737
Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis
A study testing MRI-AI guided cognitive prostate targeted biopsy and Routine cognitive prostate targeted biopsy in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. 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?
- MRI-AI guided cognitive prostate targeted biopsy and Routine cognitive prostate targeted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Apr 2026
- 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.
- Patients with 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.
- Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive years > 10ng/ml or PSA volume > 0.75/ml/years). The time interval between the two prostate biopsies should be longer than three months.
- The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted 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.
- The mpMRI did not find suspicious prostate lesions.
- Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.
- The patients could not cooperate to complete the systematic biopsy combined with targeted 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: Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Multicenter Randomized Controlled Clinical Trial
The goal of this multicenter clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system?
Read more
Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
Read the detailed description
Cognitive fusion MRI-guided targeted biopsy (cTB) has been widely used in the diagnosis of prostate cancer (PCa). However, cTB relies heavily on the operator's experience and confidence in MRI readings. Our previously single-center RCT has demonstrated the effectiveness of accurately detecting clinically significant PCa (csPCa). The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. This multicenter RCT aims to further validate the ability of MRI artificial intelligence in different institutions and investigate the generalizability of the MRI artificial intelligence assistant diagnosis system.
The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system? This multicenter RCT compared the csPCa detection rates of the AI-cTB and routine cTB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China), Beijing Miyun District Hospital (Beijing, China), and Shanghai East Hospital (Shanghai, China) from May 2024 to April 2025.
Participants were randomly allocated to AI-cTB group and routine cTB group. Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
- Conditions
- Prostate Cancer
- Being tested
- MRI-AI guided cognitive prostate targeted biopsy, Routine cognitive prostate targeted biopsy
- Keywords
- Prostate cancer, Artificial intelligence, Cognitive targeted biopsy, Diagnosis, Multicenter randomized controlled trial
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-AI guided cognitive prostate targeted biopsyProcedure or surgery
Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. Then the images with suspicious lesions highlighted by AI software were viewed by urologists. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route.
Routine cognitive prostate targeted biopsyProcedure or surgery
Before prostate biopsy, the MR images and reports were viewed by urologists preceding the biopsy. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route.
| Study group | Role | What they receive |
|---|---|---|
| MRI-AI-guided cTB (AI-cTB) group | Experimental | The trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. The urologists who were blinded to the picture archiving and communication system (PACS) and MRI reports read the AI findings at their discretion and then conducted 3-5 core TB at each suspicious lesion, followed by 12 core SB. If there was no suspicious lesion detected by the AI, only SB would be performed. Receives: Procedure: MRI-AI guided cognitive prostate targeted biopsy |
| Routine cTB group | Experimental | For patients in the cTB group, the MR images and reports were viewed by urologists preceding the biopsy. Then 3-5 core cTB were performed, followed by 12 core SB. In patients with negative MRI findings, only SB was performed. When urologists performed biopsies, ultrasound technicians and radiologists were present to provide necessary assistance. Receives: Procedure: Routine cognitive prostate 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 targeted biopsy (TB) and TB combined with systematic biopsy (SB)
csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological results of the combination of TB (AI-cTB or cTB) and SB.
Measured: One month after the biopsy procedure.
Secondary outcomes (3)
The PCa detection rate
The PCa detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB).
Measured: One month after the biopsy procedure.
The Gleason score (GS) of the biopsy sample
The Gleason score 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.
Measured: One month after the biopsy procedure.
The GS of radical prostatectomy (RP) specimens
The overall grade was assigned based on the part with the highest Gleason score according to the recommendations of the ISUP
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 posted30 Apr 2024
- Study start1 May 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (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
- 360 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
- NCT06392737
- Sponsor's protocol ID
- AITB-002
- Status last verified
- Jun 2025
- First submitted
- 26 Apr 2024
- Last updated
- 2 Jul 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06392737
- Acronym / sponsor ID
- AITB-002
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Artificial intelligence, Cognitive targeted biopsy, Diagnosis, Multicenter randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Apr 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 clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system?
Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
Detailed description
Cognitive fusion MRI-guided targeted biopsy (cTB) has been widely used in the diagnosis of prostate cancer (PCa). However, cTB relies heavily on the operator's experience and confidence in MRI readings. Our previously single-center RCT has demonstrated the effectiveness of accurately detecting clinically significant PCa (csPCa). The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. This multicenter RCT aims to further validate the ability of MRI artificial intelligence in different institutions and investigate the generalizability of the MRI artificial intelligence assistant diagnosis system.
The main questions it aims to answer are:
Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? What's the generalizability of the MRI artificial intelligence assistant diagnosis system? This multicenter RCT compared the csPCa detection rates of the AI-cTB and routine cTB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China), Beijing Miyun District Hospital (Beijing, China), and Shanghai East Hospital (Shanghai, China) from May 2024 to April 2025.
Participants were randomly allocated to AI-cTB group and routine cTB group. Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.
Participants will:
Receive AI-cTB or routine cTB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI-AI-guided cTB (AI-cTB) group | Experimental | Procedure: MRI-AI guided cognitive prostate targeted biopsyThe trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. The urologists who were blinded to the picture archiving and communication system (PACS) and MRI reports read the AI findings at their discretion and then conducted 3-5 core TB at each suspicious lesion, followed by 12 core SB. If there was no suspicious lesion detected by the AI, only SB would be performed. |
| Routine cTB group | Experimental | Procedure: Routine cognitive prostate targeted biopsyFor patients in the cTB group, the MR images and reports were viewed by urologists preceding the biopsy. Then 3-5 core cTB were performed, followed by 12 core SB. In patients with negative MRI findings, only SB was performed. When urologists performed biopsies, ultrasound technicians and radiologists were present to provide necessary assistance. |
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.
- Patients with 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.
- Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive years > 10ng/ml or PSA volume > 0.75/ml/years). The time interval between the two prostate biopsies should be longer than three months.
- The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
Key exclusion criteria (6 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.
- The mpMRI did not find suspicious prostate lesions.
- Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.
- The patients could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study.
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 |
|---|---|---|
| MRI-AI guided cognitive prostate targeted biopsyBefore prostate biopsy, the MR images of patients in the AI-cTB group were uploaded to the AI software. Then the images with suspicious lesions highlighted by AI software were viewed by urologists. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route. | Procedure or surgery | MRI-AI-guided cTB (AI-cTB) group |
| Routine cognitive prostate targeted biopsyBefore prostate biopsy, the MR images and reports were viewed by urologists preceding the biopsy. Biopsies were performed under the guidance of TRUS through the transrectal or transperineal route. | Procedure or surgery | Routine cTB group |
Primary outcome
The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (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 results of the combination of TB (AI-cTB or cTB) and SB.
3 secondary outcomes
The 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 2 Jul 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 MRI-AI guided cognitive prostate targeted biopsy and Routine cognitive prostate 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 6 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 2 Jul 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 for targeted biopsy (TB) and TB combined with systematic biopsy (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 2 Jul 2025; AzTrials last refreshed its copy on 3 Nov 2026.