Prostate CancerIBIS-PCNCT07795723
Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis
A study testing MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy and MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time… Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy and MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to Apr 2027
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants older than 18 years.
- Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy.
- Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5.
- Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower.
- Able to tolerate and undergo transperineal prostate biopsy.
- Willing to participate in the study and able to provide written informed consent.
Who cannot join
- Prior prostate biopsy.
- Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery.
- Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher.
- Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy.
- In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.
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
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu
Haifeng Huang, +86-186-5165-8099
About this study
Official title: A Prospective, Multicenter, Open-Label, Randomized, Parallel-Group, Noninferiority Trial of MRI/Ultrasound Cognitive Fusion Targeted Biopsy Combined With Ipsilateral Versus Bilateral Systematic Biopsy for Prostate Cancer Diagnosis
Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time, pathological workload, and biopsy-related complications.
This prospective, multicenter, open-label, randomized noninferiority trial will enroll 454 biopsy-naive men with suspected prostate cancer, a unilateral prostate MRI lesion with a highest PI-RADS score of 4 or 5, and prostate-specific antigen levels of 20 ng/mL or lower. Participants will be randomly assigned in a 1:1 ratio to receive transperineal MRI/US cognitive fusion targeted biopsy combined with either a 6-core ipsilateral systematic biopsy or a standard 12-core bilateral systematic biopsy.
The primary objective is to determine whether the ipsilateral systematic biopsy strategy is noninferior to the bilateral systematic biopsy strategy for detecting clinically significant prostate cancer, defined as International Society of Urological Pathology Grade Group 2 or higher. The study will also compare overall prostate cancer detection, biopsy core numbers, pain and discomfort, procedure time, pathological workload and costs, urinary symptoms, quality of life, and biopsy-related adverse events and complications through 30 days after biopsy.
- Conditions
- Prostate Cancer
- Being tested
- MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy, MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy
- Keywords
- Prostate Biopsy, MRI-Targeted Biopsy, Cognitive Fusion Biopsy, Transperineal Prostate Biopsy, Systematic Biopsy, Ipsilateral Systematic Biopsy, Bilateral Systematic Biopsy, Clinically Significant Prostate Cancer, PI-RADS, Noninferiority Trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic BiopsyProcedure or surgery
Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a 6-core systematic biopsy limited to the MRI lesion side, sampling the medial and lateral regions of the base, midgland, and apex. Local anesthesia will be limited to the MRI lesion side.
MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic BiopsyProcedure or surgery
Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a standard 12-core bilateral systematic biopsy sampling the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered.
| Study group | Role | What they receive |
|---|---|---|
| TB+iSB | Experimental | Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a 6-core ipsilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on the MRI lesion side. Local anesthesia will be administered only on the MRI lesion side. Receives: Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy |
| TB+SB | Active comparator | Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a standard 12-core bilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered. Receives: Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection Rate of Clinically Significant Prostate Cancer
The proportion of participants with clinically significant prostate cancer detected by the assigned biopsy strategy. Clinically significant prostate cancer is defined as biopsy pathology showing International Society of Urological Pathology (ISUP) Grade Group 2 or higher. The between-group risk difference will be calculated as TB+iSB minus TB+SB. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval is greater than -15%.
Measured: Day 14 after biopsy
Secondary outcomes (14)
Overall Prostate Cancer Detection Rate
The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
Measured: Day 14 after biopsy
Clinically Insignificant Prostate Cancer Detection Rate
The proportion of participants with biopsy pathology showing ISUP Grade Group 1 prostate cancer and no lesion with ISUP Grade Group 2 or higher.
Measured: Day 14 after biopsy
High-Grade Prostate Cancer Detection Rate
The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
Measured: Day 14 after biopsy
Pain Numeric Rating Scale Score
Biopsy-related pain associated with local anesthesia, needle puncture, and biopsy core acquisition will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain. Higher scores indicate greater pain.
Measured: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
Overall Discomfort Numeric Rating Scale Score
Overall procedural discomfort related to instrument insertion, ultrasound positioning or pressure, prostatic pressure, pelvic floor traction, foreign-body sensation, positioning, and the biopsy procedure will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10. A score of 0 indicates no discomfort and a score of 10 indicates the worst imaginable discomfort. Higher scores indicate greater discomfort.
Measured: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
Procedure Time
Procedure time in minutes, measured from the start of local anesthesia to completion of the final biopsy core. For the TB+iSB group, timing begins when local anesthesia is started on the MRI lesion side. For the TB+SB group, timing begins when bilateral local anesthesia is started.
Measured: During the biopsy procedure
Total Number of Biopsy Cores
The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded.
Measured: During the biopsy procedure
Number of Pathology Specimen Containers
The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant.
Measured: Periprocedural
Total Pathology-Related Costs
Total pathology-related costs associated with biopsy specimen handling, processing, histological examination, and pathology reporting will be obtained from the applicable hospital records for each participant.
Measured: Up to 2 weeks after biopsy
Incidence of Biopsy-Related Adverse Events and Complications
The proportion of participants experiencing any biopsy-related adverse event or complication will be assessed. Events include gross hematuria, hematospermia, perineal hematoma, fever or infection, urinary retention, syncope, emergency department visits, unplanned or prolonged hospitalization, serious adverse events, and additional medical interventions required because of a complication.
Measured: From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
Severity of Biopsy-Related Complications by Clavien-Dindo Grade
The maximum Clavien-Dindo grade of biopsy-related complications will be recorded for each participant. Grades range from I to V, with higher grades indicating greater severity: Grade I indicates a minor deviation from the expected postoperative course; Grade II requires pharmacological treatment; Grade III requires an intervention; Grade IV indicates a life-threatening complication requiring intensive care; and Grade V indicates death.
Measured: From biopsy through 30 days after biopsy
Change From Baseline in International Prostate Symptom Score
The International Prostate Symptom Score consists of 7 questions assessing lower urinary tract symptoms. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
Measured: Baseline and 7 days after biopsy (±2 days)
Change From Baseline in IPSS Quality of Life Score
The quality of life question associated with the International Prostate Symptom Score ranges from 0 to 6, with higher scores indicating greater dissatisfaction with the participant's urinary condition. Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
Measured: Baseline and 7 days after biopsy (±2 days)
Number of Histology Slides
The total number of histology slides generated for biopsy specimen processing and pathological diagnosis will be recorded for each participant.
Measured: Up to 2 weeks after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start20 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Model description
- Participants will be stratified by the highest PI-RADS score (PI-RADS 4 or PI-RADS 5) and randomly assigned in a 1:1 ratio to one of two parallel biopsy strategy groups: MRI/ultrasound cognitive fusion targeted biopsy plus ipsilateral 6-core systematic biopsy, or MRI/ultrasound cognitive fusion targeted biopsy plus standard bilateral 12-core systematic biopsy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huai'an First People's Hospital, Northern Jiangsu People's Hospital, Beijing Hospital, The First People's Hospital of Changzhou, Nantong First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795723
- Sponsor's protocol ID
- IUNU-PC-131
- Other IDs
- 2026-0723-02
- Acronym
- IBIS-PC
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: An individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant data will be considered only with approval from the sponsor and the relevant ethics committee and in accordance with applicable laws, regulations, and privacy protection requirements.
Publications
Cheng Y, Huang H, Wang M, Zhu L, Peng S, Li D, Marra G, Qi R, Ding X, Liu M, Qiu X, Guo H. Magnetic resonance imaging-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: A multicenter, paired, noninferiority, observational trial. Cancer. 2026 Jul 1;132(13):e70493. doi: 10.1002/cncr.70493.
PubMed 42319125
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-Label, Randomized, Parallel-Group, Noninferiority Trial of MRI/Ultrasound Cognitive Fusion Targeted Biopsy Combined With Ipsilateral Versus Bilateral Systematic Biopsy for Prostate Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT07795723
- Acronym / sponsor ID
- IBIS-PC / IUNU-PC-131
- Conditions
- Prostate Cancer
- Keywords
- Prostate Biopsy, MRI-Targeted Biopsy, Cognitive Fusion Biopsy, Transperineal Prostate Biopsy, Systematic Biopsy, Ipsilateral Systematic Biopsy, Bilateral Systematic Biopsy, Clinically Significant Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Huai'an First People's Hospital, Northern Jiangsu People's Hospital, Beijing Hospital, The First People's Hospital of Changzhou, Nantong First People's Hospital
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 Aug 2026 (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.
Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time, pathological workload, and biopsy-related complications.
This prospective, multicenter, open-label, randomized noninferiority trial will enroll 454 biopsy-naive men with suspected prostate cancer, a unilateral prostate MRI lesion with a highest PI-RADS score of 4 or 5, and prostate-specific antigen levels of 20 ng/mL or lower. Participants will be randomly assigned in a 1:1 ratio to receive transperineal MRI/US cognitive fusion targeted biopsy combined with either a 6-core ipsilateral systematic biopsy or a standard 12-core bilateral systematic biopsy.
The primary objective is to determine whether the ipsilateral systematic biopsy strategy is noninferior to the bilateral systematic biopsy strategy for detecting clinically significant prostate cancer, defined as International Society of Urological Pathology Grade Group 2 or higher. The study will also compare overall prostate cancer detection, biopsy core numbers, pain and discomfort, procedure time, pathological workload and costs, urinary symptoms, quality of life, and biopsy-related adverse events and complications through 30 days after biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be stratified by the highest PI-RADS score (PI-RADS 4 or PI-RADS 5) and randomly assigned in a 1:1 ratio to one of two parallel biopsy strategy groups: MRI/ultrasound cognitive fusion targeted biopsy plus ipsilateral 6-core systematic biopsy, or MRI/ultrasound cognitive fusion targeted biopsy plus standard bilateral 12-core systematic biopsy.
| Arm | Type | Receives |
|---|---|---|
| TB+iSB | Experimental | Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic BiopsyParticipants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a 6-core ipsilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on the MRI lesion side. Local anesthesia will be administered only on the MRI lesion side. |
| TB+SB | Active comparator | Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic BiopsyParticipants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a standard 12-core bilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male participants older than 18 years.
- Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy.
- Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5.
- Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower.
- Able to tolerate and undergo transperineal prostate biopsy.
Key exclusion criteria (5 listed)
- Prior prostate biopsy.
- Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery.
- Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher.
- Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy.
- In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.
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/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic BiopsyTransperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a 6-core systematic biopsy limited to the MRI lesion side, sampling the medial and lateral regions of the base, midgland, and apex. Local anesthesia will be limited to the MRI lesion side. | Procedure or surgery | TB+iSB |
| MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic BiopsyTransperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a standard 12-core bilateral systematic biopsy sampling the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered. | Procedure or surgery | TB+SB |
Primary outcome
Detection Rate of Clinically Significant Prostate Cancer
Time frame: Day 14 after biopsy
The proportion of participants with clinically significant prostate cancer detected by the assigned biopsy strategy. Clinically significant prostate cancer is defined as biopsy pathology showing International Society of Urological Pathology (ISUP) Grade Group 2 or higher. The between-group risk difference will be calculated as TB+iSB minus TB+SB. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval is greater than -15%.
14 secondary outcomes
Overall Prostate Cancer Detection Rate
Time frame: Day 14 after biopsy
Clinically Insignificant Prostate Cancer Detection Rate
Time frame: Day 14 after biopsy
High-Grade Prostate Cancer Detection Rate
Time frame: Day 14 after biopsy
Pain Numeric Rating Scale Score
Time frame: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
Overall Discomfort Numeric Rating Scale Score
Time frame: Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
Procedure Time
Time frame: During the biopsy procedure
Total Number of Biopsy Cores
Time frame: During the biopsy procedure
Number of Pathology Specimen Containers
Time frame: Periprocedural
Total Pathology-Related Costs
Time frame: Up to 2 weeks after biopsy
Incidence of Biopsy-Related Adverse Events and Complications
Time frame: From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
Severity of Biopsy-Related Complications by Clavien-Dindo Grade
Time frame: From biopsy through 30 days after biopsy
Change From Baseline in International Prostate Symptom Score
Time frame: Baseline and 7 days after biopsy (±2 days)
Change From Baseline in IPSS Quality of Life Score
Time frame: Baseline and 7 days after biopsy (±2 days)
Number of Histology Slides
Time frame: Up to 2 weeks after 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 31 Aug 2026.
- Results publication: PubMed 42319125Cheng Y, Huang H, Wang M, Zhu L, Peng S, Li D, Marra G, Qi R, Ding X, Liu M, Qiu X, Guo H. Magnetic resonance imaging-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: A multicenter, paired, noninferiority, observational trial. Cancer. 2026 Jul 1;132(13):e70493. doi: 10.1002/cncr.70493.
- Individual participant dataSharing planned: Undecided. An individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant data will be considered only with approval from the sponsor and the relevant ethics committee and in accordance with applicable laws, regulations, and privacy protection requirements.
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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.
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/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy and MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 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: looking for participants now, as of the sponsor's last update on 31 Aug 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?
Contact Haifeng Huang (+86-186-5165-8099, 24083491@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection Rate of Clinically Significant Prostate Cancer (time frame: Day 14 after biopsy). 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 NCT07795723, which also lists 1 linked publication.
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 31 Aug 2026.