Prostate CancerNCT06575361
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
A study testing Combination of targeted biopsy and systematic biopsy in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). 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?
- Combination of targeted biopsy and systematic biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Aug 2025
- 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.
- Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control.
- 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 had no history of prior prostate surgery or biopsy.
- The PSA of patients should be ≤20 ng/mL.
- The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month.
- Patients with complete clinical information.
Who cannot join
- The clinicopathological information and 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 received prior prostate biopsy.
- Patients had contraindications to MRI or prostate biopsy.
- Patients were not in accordance with the indication of prostate biopsy.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.
Read more
Participants will:
Receive combination of systematic biopsy and targeted biopsy.
Read the detailed description
In recent years, there have been remarkable advancements in the field of artificial intelligence (AI) techniques, particularly in the medical domain. These AI techniques have demonstrated the ability to significantly enhance various medical tasks, such as tumor detection, classification, and prognosis prediction. Increasing evidence supports the ability of AI to facilitate precise diagnosis of PCa and assist in therapeutic decisions. Compared with doctors, AI has the potential to identify not only holistic tumor morphology but also task-specific and granular radiological patterns that cannot be detected by the naked eye. Therefore, AI has great potential to reduce inconsistencies between observers and improve diagnostic accuracy. Previous AI studies at our institution have developed deep learning-based AI models trained on MR images that achieve good performance in the detection and localization of clinically significant prostate cancer (csPCa). Furthermore, the trained AI algorithms were embedded into proprietary structured reporting software, and radiologists simulated their real-life work scenarios to interpret and report the PI-RADS category of each patient using this AI-based software. However, the data is mostly retrospective. The capability of detecting the suspicious lesions on MRI, guiding the prostate targeted biopsy, and optimizing the biopsy scheme warrants further investigation.
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.
Participants will:
Receive combination of systematic biopsy and targeted biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Combination of targeted biopsy and systematic biopsy
- Keywords
- Prostate cancer, Artificial intelligence, Targeted biopsy, Diagnosis, Diagnostic study
- 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.
Combination of targeted biopsy and systematic biopsyDiagnostic test
Before prostate biopsy, the MR images of patients were independently reviewed by MRI-AI and urogenital radiologists. Then the images with suspicious lesions highlighted by MRI-AI and urogenital radiologists. Urologists conducted targeted biopsies for all suspicious lesions and systematic biopsies. Biopsies were performed under the guidance of transrectal ultrasound (TRUS) through the transrectal or transperineal route.
| Study group | Role | What they receive |
|---|---|---|
| Patients with the indication of prostate biopsy | Experimental | The trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. Urogenital radiologists who were blinded to MRI-AI reports independently reviewed the MR images, annotated the suspicious lesions. Then the urologists read both the MRI-AI reports and urogenital radiologist's reports, and conducted 3-5 core targeted biopsy (TB) at each suspicious lesion found by MRI-AI and urogenital radiologists, followed by 12 core systematic biopsy (SB). Receives: Diagnostic Test: Combination of targeted biopsy and systematic 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 suspicious lesions found by MRI-AI and urogenital radiologists
csPCa was defined as PCa with a grade group ≥ 2 or GS ≥ 3+4. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
Measured: One month after the biopsy procedure.
High-grade PCa detection rate
High-grade PCa was defined as PCa with a grade group ≥3 or GS ≥ 4+3. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
Measured: One month after the biopsy procedure.
Secondary outcomes (3)
The PCa detection rate
The PCa detection rate for the suspicious lesions found by MRI-AI and urogenital radiologists.
Measured: One month after the biopsy procedure.
clinically insignificant PCa (ciPCa) detection rate
ciPCa was defined as PCa with a grade group=1 or GS=3+3. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
Measured: One month after the biopsy procedure.
Diagnostic performance
Diagnostic performance assessment includes accuracy, sensitivity, specificity, negative predicative value, and positive predicative value
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 posted28 Aug 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion31 Aug 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 365 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
- NCT06575361
- Sponsor's protocol ID
- AITB-003
- Status last verified
- May 2026
- First submitted
- 26 Aug 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis: a Real-World Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT06575361
- Acronym / sponsor ID
- AITB-003
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Artificial intelligence, Targeted biopsy, Diagnosis, Diagnostic study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Aug 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 real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.
Participants will:
Receive combination of systematic biopsy and targeted biopsy.
Detailed description
In recent years, there have been remarkable advancements in the field of artificial intelligence (AI) techniques, particularly in the medical domain. These AI techniques have demonstrated the ability to significantly enhance various medical tasks, such as tumor detection, classification, and prognosis prediction. Increasing evidence supports the ability of AI to facilitate precise diagnosis of PCa and assist in therapeutic decisions. Compared with doctors, AI has the potential to identify not only holistic tumor morphology but also task-specific and granular radiological patterns that cannot be detected by the naked eye. Therefore, AI has great potential to reduce inconsistencies between observers and improve diagnostic accuracy. Previous AI studies at our institution have developed deep learning-based AI models trained on MR images that achieve good performance in the detection and localization of clinically significant prostate cancer (csPCa). Furthermore, the trained AI algorithms were embedded into proprietary structured reporting software, and radiologists simulated their real-life work scenarios to interpret and report the PI-RADS category of each patient using this AI-based software. However, the data is mostly retrospective. The capability of detecting the suspicious lesions on MRI, guiding the prostate targeted biopsy, and optimizing the biopsy scheme warrants further investigation.
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.
Participants will:
Receive combination of systematic biopsy and targeted biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with the indication of prostate biopsy | Experimental | Diagnostic Test: Combination of targeted biopsy and systematic biopsyThe trained AI algorithms were embedded into proprietary structured reporting software. Before prostate biopsy, the MR images of patients were uploaded to the AI software. The prostate gland and suspicious lesions were annotated and highlighted by AI software. Urogenital radiologists who were blinded to MRI-AI reports independently reviewed the MR images, annotated the suspicious lesions. Then the urologists read both the MRI-AI reports and urogenital radiologist's reports, and conducted 3-5 core targeted biopsy (TB) at each suspicious lesion found by MRI-AI and urogenital radiologists, followed by 12 core systematic biopsy (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.
- Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control.
- 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 had no history of prior prostate surgery or biopsy.
- The PSA of patients should be ≤20 ng/mL.
Key exclusion criteria (5 listed)
- The clinicopathological information and 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 received prior prostate biopsy.
- Patients had contraindications to MRI or prostate biopsy.
- 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 |
|---|---|---|
| Combination of targeted biopsy and systematic biopsyBefore prostate biopsy, the MR images of patients were independently reviewed by MRI-AI and urogenital radiologists. Then the images with suspicious lesions highlighted by MRI-AI and urogenital radiologists. Urologists conducted targeted biopsies for all suspicious lesions and systematic biopsies. Biopsies were performed under the guidance of transrectal ultrasound (TRUS) through the transrectal or transperineal route. | Diagnostic test | Patients with the indication of prostate biopsy |
Primary outcome
The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists
Time frame: One month after the biopsy procedure.
csPCa was defined as PCa with a grade group ≥ 2 or GS ≥ 3+4. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
High-grade PCa detection rate
Time frame: One month after the biopsy procedure.
High-grade PCa was defined as PCa with a grade group ≥3 or GS ≥ 4+3. The reference standard was the pathological results of targeted biopsies for the suspicious lesions.
3 secondary outcomes
The PCa detection rate
Time frame: One month after the biopsy procedure.
clinically insignificant PCa (ciPCa) detection rate
Time frame: One month after the biopsy procedure.
Diagnostic performance
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 6 May 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. 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 Combination of targeted biopsy and systematic 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 7 inclusion and 5 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 6 May 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?
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 suspicious lesions found by MRI-AI and urogenital radiologists (time frame: One month after the biopsy procedure.). The study lists 2 primary outcomes in all. 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 6 May 2026.