Prostate CancerNCT04271527
Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
A study testing cognitive fusion targeted biopsy in people with Prostate Cancer, run by Shanghai East Hospital at 1 site in China.
Trial summary
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa. 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?
- cognitive fusion targeted biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 14 May 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 increase to 4-20 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, 1 recruiting
- Recruiting
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Biming He, MD, +8615502139410, 190589109@qq.com
Haifeng Wang, MD, +8613681750891, 446720864@qq.com
About this study
Official title: Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Read the detailed description
This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
- Conditions
- Prostate Cancer
- Being tested
- cognitive fusion targeted biopsy
- Keywords
- prostate cancer, cognitive fusion targeted biopsy, software-based fusion 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.
cognitive fusion targeted biopsyProcedure or surgery
A cognitive fusion targeted biopsy
| Study group | Role | What they receive |
|---|---|---|
| cognitive targeted biopsy | Experimental | a cognitive fusion targeted biopsy combined with a systematic biopsy Receives: Procedure: cognitive fusion targeted biopsy |
| software targeted biopsy | Active comparator | software-based fusion targeted biopsy combined with a systematic biopsy Receives: Procedure: cognitive fusion targeted biopsy |
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 for targeted biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Measured: 5-6 weeks after signing the consent
Secondary outcomes (10)
The detection rate of any prostate cancer for targeted biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples
Measured: 5-6 weeks after signing the consent
The detection rate of any prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples
Measured: 5-6 weeks after signing the consent
Prostate volume
To measure the prostate volume by ultrasound and MRI
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm
Proportion of separate suspicious lesion with maximum diameter <0.5cm, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm
Proportion of separate suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm
Proportion of separate suspicious lesion with maximum diameter >1.0 cm, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3
Proportion of separate suspicious lesion with PI-RADS 3, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4
Proportion of separate suspicious lesion with PI-RADS 4, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5
Proportion of separate suspicious lesion with PI-RADS 5, detected ISUP grade group>=2 cancers by targeted biopsy only.
Measured: 5-6 weeks after signing the consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Feb 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion14 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, First Affiliated Hospital Xi'an Jiaotong University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Henan university of CM, Second Affiliated Hospital of Xi'an Jiaotong University, Peking University First Hospital, The University of Hong Kong-Shenzhen Hospital
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, MD, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271527
- Sponsor's protocol ID
- CSTB-2019-001
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2020
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
He BM, Zhang K, Zhou Z, Chen X, Liu Y, Dong B, Wang Y, Xing Y, He W, Jin Z, Zhang T, Feng T, Liang L, Chen B, Chen S, Lu Z, Zhou S, Zhao Y, Liu Y, Wang Z, Na R, Zhang X, Shi B, Wang HF; IMAGINATION Group. Cognitive Versus Software-based Fusion Targeted Biopsy for the Diagnosis of Clinically Significant Prostate Cancer: A Multicenter, Randomized, Noninferiority Trial (IMAGINATION). Eur Urol. 2026 Jul 10:S0302-2838(26)02243-8. doi: 10.1016/j.eururo.2026.06.020. Online ahead of print.
PubMed 42431755He B, Li R, Li D, Huang L, Wen X, Yang G, Wang H. Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy. BMJ Open. 2021 Feb 5;11(2):e041427. doi: 10.1136/bmjopen-2020-041427.
PubMed 33550242
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
- ClinicalTrials.gov ID
- NCT04271527
- Acronym / sponsor ID
- CSTB-2019-001
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, cognitive fusion targeted biopsy, software-based fusion targeted biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 626 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, First Affiliated Hospital Xi'an Jiaotong University, Qilu Hospital of Shandong University, The First Affiliated Hospital of Zhengzhou University, Zibo Central Hospital, Shandong Provincial Hospital, The First Affiliated Hospital of Henan university of CM, Second Affiliated Hospital of Xi'an Jiaotong University, Peking University First Hospital, The University of Hong Kong-Shenzhen Hospital
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 17 Feb 2020 (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 is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Detailed description
This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive targeted biopsy | Experimental | Procedure: cognitive fusion targeted biopsya cognitive fusion targeted biopsy combined with a systematic biopsy |
| software targeted biopsy | Active comparator | Procedure: cognitive fusion targeted biopsysoftware-based fusion targeted biopsy combined with a systematic biopsy |
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 increase to 4-20 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 |
|---|---|---|
| cognitive fusion targeted biopsyA cognitive fusion targeted biopsy | Procedure or surgery | cognitive targeted biopsy, software targeted biopsy |
Primary outcome
The detection rate of clinically significant prostate cancer for targeted biopsy
Time frame: 5-6 weeks after signing the consent
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
10 secondary outcomes
The detection rate of any prostate cancer for targeted biopsy
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer for combined biopsy
Time frame: 5-6 weeks after signing the consent
The detection rate of any prostate cancer for combined biopsy
Time frame: 5-6 weeks after signing the consent
Prostate volume
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5
Time frame: 5-6 weeks after signing the consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 42431755He BM, Zhang K, Zhou Z, Chen X, Liu Y, Dong B, Wang Y, Xing Y, He W, Jin Z, Zhang T, Feng T, Liang L, Chen B, Chen S, Lu Z, Zhou S, Zhao Y, Liu Y, Wang Z, Na R, Zhang X, Shi B, Wang HF; IMAGINATION Group. Cognitive Versus Software-based Fusion Targeted Biopsy for the Diagnosis of Clinically Significant Prostate Cancer: A Multicenter, Randomized, Noninferiority Trial (IMAGINATION). Eur Urol. 2026 Jul 10:S0302-2838(26)02243-8. doi: 10.1016/j.eururo.2026.06.020. Online ahead of print.
- Derived from this study: PubMed 33550242He B, Li R, Li D, Huang L, Wen X, Yang G, Wang H. Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy. BMJ Open. 2021 Feb 5;11(2):e041427. doi: 10.1136/bmjopen-2020-041427.
- 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.
Haifeng Wang, MD principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive fusion targeted biopsy 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 16 Aug 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 Biming He, MD (+8615502139410, 190589109@qq.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 for targeted biopsy (time frame: 5-6 weeks after signing the consent). 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 NCT04271527, which also lists 2 linked publications.
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 16 Aug 2024.