Prostate CancerNCT05761912
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
An observational study of Prostate Cancer and Ultrasound, run by Shanghai Minhang Central Hospital at 1 site in China.
Trial summary
To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prostate Cancer, Ultrasound, Radiomics
- What is being tested?
- Targeted biopsy
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 25 Oct 2026
- Phase
- Observational
- 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 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.
Who may be able to join
- Age ≥55 years old.
- Patients had tPSA/fPSA within 1 month before biopsy.
- Patients had any of the following indications for prostate biopsy:
- Suspicious prostate nodules were found by digital rectal examination
- Suspicious lesions were detected by B-ultrasound or MRI
- PSA>10ng/ml
- PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values
Who cannot join
- malignant tumors other than prostate adenocarcinoma indicated by pathology.
- Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
- Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc
Trial locations and contacts
1 site in 1 country.
About this study
To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.
Read the detailed description
Researchers plan to develop a diagnostic and prognostic evaluation model for prostate cancer by analyzing abnormal echoes in prostate ultrasound images through radiomics. This model will be used to guide ultrasound radiomics-fusion prostate biopsy, and its accuracy will be compared with that of systematic biopsy.
- Conditions
- Prostate Cancer, Ultrasound, Radiomics
- Being tested
- 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.
Targeted biopsyDiagnostic test
For the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound fusion targeted biopsy | Prostate ultrasound had abnormal echo and radiomics analysis showed high scores Receives: Diagnostic Test: Targeted biopsy | |
| Systematic biopsy | Patients meeting the indications for prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of ultrasound radiomics fusion targeted biopsy
Positive rate of ultrasound radiomics fusion targeted biopsy
Measured: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of systematic biopsy
Positive rate of systematic biopsy
Measured: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
Measured: Up to seventh day when the pathological results were obtained after the targeted biopsy
Ultrasound radiomics parameters
The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer/ITK-SNAP software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.
Measured: The 30min following the transrectal ultrasonography
Secondary outcomes (3)
Gleason's score of positive tissue
Gleason's score of positive tissue from targeted prostate biopsy. Prostate cancer was graded by Gleason score (GS) ranging from 6 to 10. Tumors of GS 6 (3 + 3) are considered low grade (LG), while GS ≥7 are high grade (HG).
Measured: Up to seventh day when the pathological results were obtained after the targeted biopsy
PI-RADS score
Prostate Imaging Reporting and Data System (PI-RADS) score was obtained according to multiparametric magnetic resonance imaging. PI-RADS is used to standardize interpretation of prostate MRI. Each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer. PI-RADS 1: clinically significant cancer is highly unlikely to be present; PI-RADS 2: clinically significant cancer is unlikely to be present; PI-RADS 3: the presence of clinically significant cancer is equivocal; PI-RADS 4: clinically significant cancer is likely to be present; PI-RADS 5: clinically significant cancer is highly likely to be present.
Measured: Within one month prior to prostate biopsy.
Incidence of complications
Incidence of complications associated with prostate biopsy
Measured: Up to the first month after the targeted biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start23 Jun 2025
- Primary completion5 Oct 2026
- Study completion25 Oct 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minhang Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation, Shanghai Municipal Commission of Health and Family Planning
- Responsible party
- Principal investigator, Chang He, Shanghai Minhang Central Hospital
- Investigators
- Jiaqi Huang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761912
- Sponsor's protocol ID
- Prostate Radiomics-1027
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
- ClinicalTrials.gov ID
- NCT05761912
- Acronym / sponsor ID
- Prostate Radiomics-1027
- Conditions
- Prostate Cancer, Ultrasound, Radiomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Minhang Central HospitalUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation, Shanghai Municipal Commission of Health and Family Planning
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 5 Oct 2026 (actual)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 9 Mar 2023 (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.
To predict prostate cancer by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.
Detailed description
Researchers plan to develop a diagnostic and prognostic evaluation model for prostate cancer by analyzing abnormal echoes in prostate ultrasound images through radiomics. This model will be used to guide ultrasound radiomics-fusion prostate biopsy, and its accuracy will be compared with that of systematic biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound fusion targeted biopsy | – | Diagnostic Test: Targeted biopsyProstate ultrasound had abnormal echo and radiomics analysis showed high scores |
| Systematic biopsy | – | –Patients meeting the indications for prostate biopsy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.
Key inclusion criteria (7 listed)
- Age ≥55 years old.
- Patients had tPSA/fPSA within 1 month before biopsy.
- Patients had any of the following indications for prostate biopsy:
Key exclusion criteria (3 listed)
- malignant tumors other than prostate adenocarcinoma indicated by pathology.
- Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
- Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc
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 |
|---|---|---|
| Targeted biopsyFor the high-risk targets identified by the radiomics model, perform targeted biopsy under ultrasound fusion. | Diagnostic test | Ultrasound fusion targeted biopsy |
Primary outcome
Positive rate of ultrasound radiomics fusion targeted biopsy
Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of ultrasound radiomics fusion targeted biopsy
Positive rate of systematic biopsy
Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of systematic biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy
Positive rate of mpMRI cognitive fusion targeted biopsy
Ultrasound radiomics parameters
Time frame: The 30min following the transrectal ultrasonography
The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer/ITK-SNAP software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.
3 secondary outcomes
Gleason's score of positive tissue
Time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy
PI-RADS score
Time frame: Within one month prior to prostate biopsy.
Incidence of complications
Time frame: Up to the first month after the targeted biopsy
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 6 Oct 2026.
- 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.
Jiaqi Huang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Ultrasound, run by Shanghai Minhang Central 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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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?
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?
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?
Positive rate of ultrasound radiomics fusion targeted biopsy (time frame: Up to seventh day when the pathological results were obtained after the targeted biopsy). The study lists 4 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 Oct 2026.