Prostate CancerNCT06441292
Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation
A study testing AI-assisted and Non-AI-assisted in people with Prostate Cancer, run by Shanghai East Hospital at 1 site in China.
Trial summary
This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- AI-assisted and Non-AI-assisted
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 15 Jul 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- PSA > 4 ng/ml and/or abnormal DRE
- Sign the informed consent
Who cannot join
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, 200120
About this study
Official title: Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.
Read the detailed description
This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- AI-assisted, Non-AI-assisted
- Keywords
- Prostate Cancer, targeted 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.
AI-assistedProcedure or surgery
utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process
Non-AI-assistedProcedure or surgery
undergo standard prostate biopsy procedures without additional technological assistance
| Study group | Role | What they receive |
|---|---|---|
| conventional biopsy group | Active comparator | undergo standard prostate biopsy procedures without additional technological assistance Receives: Procedure: Non-AI-assisted |
| AI-assisted biopsy group | Experimental | utilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process Receives: Procedure: AI-assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of clinically significant prostate cancer by targeted biopsy alone
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Measured: 2-3 weeks post-biopsy
Secondary outcomes (3)
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined targeted biopsy samples
Measured: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy alone
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
Measured: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined targeted biopsy samples
Measured: 2-3 weeks post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441292
- Sponsor's protocol ID
- PB-NAV-MMIF-01
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
- ClinicalTrials.gov ID
- NCT06441292
- Acronym / sponsor ID
- PB-NAV-MMIF-01
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, targeted biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 4 Jun 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.
This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.
Detailed description
This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional biopsy group | Active comparator | Procedure: Non-AI-assistedundergo standard prostate biopsy procedures without additional technological assistance |
| AI-assisted biopsy group | Experimental | Procedure: AI-assistedutilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- PSA > 4 ng/ml and/or abnormal DRE
- Sign the informed consent
Key exclusion criteria (4 listed)
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this trial
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 |
|---|---|---|
| AI-assistedutilize advanced deep learning models that integrate multi-modal image fusion from multi-parameter ultrasound and MRI to guide the biopsy process | Procedure or surgery | AI-assisted biopsy group |
| Non-AI-assistedundergo standard prostate biopsy procedures without additional technological assistance | Procedure or surgery | conventional biopsy group |
Primary outcome
The detection rate of clinically significant prostate cancer by targeted biopsy alone
Time frame: 2-3 weeks post-biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
3 secondary outcomes
The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
Time frame: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy alone
Time frame: 2-3 weeks post-biopsy
The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
Time frame: 2-3 weeks post-biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted and Non-AI-assisted in people with Prostate Cancer, run by Shanghai East 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuaidong wang (15102100859, wangshuaidong_wsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of clinically significant prostate cancer by targeted biopsy alone (time frame: 2-3 weeks post-biopsy). 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 4 Jun 2024.