Prostate BiopsyNCT07600216
A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men
A study testing Robotic-Assisted Fusion Biopsy and Expert Cognitive Fusion Biopsy in people with Prostate Biopsy, run by Shanghai East Hospital.
Trial summary
The trial aims to find out if using a robotic system to help perform prostate biopsies is better than having a highly experienced doctor perform the biopsy by hand in men with a high Body Mass Index (BMI). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Robotic-Assisted Fusion Biopsy and Expert Cognitive Fusion Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 May 2028
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years.
- Serum PSA levels between 4 and 20 ng/ml and/or abnormal digital rectal examination (DRE).
- High Body Mass Index (BMI): defined as ≥ 28 kg/m ² for Asian cohorts and ≥ 30 kg/m ² for Non-Asian cohorts.
- MRI-Positive: Presence of at least one suspicious lesion (PI-RADS score ≥ 3) on mpMRI.
- Fitness for transperineal biopsy under local anaesthesia or conscious sedation.
Who cannot join
- Prior treatment for prostate cancer.
- History of major anorectal surgery preventing safe transperineal probe insertion.
- Contraindications to MRI.
- Negative screening MRI (PI-RADS 1-2).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The trial aims to find out if using a robotic system to help perform prostate biopsies is better than having a highly experienced doctor perform the biopsy by hand in men with a high Body Mass Index (BMI).
While MRI-guided prostate biopsies are highly effective, carrying them out in men with obesity can be physically challenging for doctors. Extra pelvic tissue increases the depth the biopsy needle must travel and makes it difficult to manually hold the ultrasound probe perfectly steady. This physical difficulty might cause doctors to miss some aggressive prostate cancers.
Read more
This study tests whether a robotic arm-which completely locks the biopsy needle on target and eliminates human hand tremors-can improve cancer detection. The study will enroll up to 570 men with high BMI who have suspicious areas on their prostate MRI. Participants will be randomly assigned to receive either a robotic-assisted biopsy or a standard manual biopsy performed by an expert urologist.
To ensure the results are completely unbiased, participants will not know which method is being used on them. They will be placed behind a surgical drape and wear noise-canceling headphones playing music during the procedure to block out the sounds of the robotic motors. The main goal is to see if the robotic method safely and significantly increases the detection rate of clinically significant prostate cancer in this specific group of patients.
Read the detailed description
The integration of multiparametric magnetic resonance imaging (mpMRI) with transperineal targeted biopsy has established a new standard for prostate cancer diagnosis. However, clinical evidence, including findings from the previous IMAGINATION trial, suggests that the diagnostic accuracy of manual targeted biopsy techniques degrades significantly in patients with high Body Mass Index (BMI).
Deep perineal adiposity creates a "hostile anatomical environment." It increases the skin-to-apex distance and introduces a "fulcrum effect," where the extensive soft tissue acts as a pivot point that amplifies manual tremors and restricts the operator's physical ability to steer the transperineal probe accurately. This mechanical barrier contributes to the "Obesity Paradox," wherein men with obesity face a higher risk of harboring undiagnosed, advanced high-grade prostate cancer.
The ROBUST (Robotic Optimization for Biopsy Under Substantial Tissue) trial is an investigator-initiated, international, multicenter, randomized controlled trial designed to determine if robotic stabilization can serve as a "technical equalizer" for this specific anatomical challenge.
Unlike conventional device trials, ROBUST utilizes a Bayesian adaptive hierarchical non-inferiority to superiority design. It aims to test whether robotic-assisted fusion biopsy is strictly non-inferior (with a -5% margin), and subsequently superior, to expert cognitive fusion biopsy. To rigorously isolate the impact of mechanical stabilization from operator inexperience, the control arm explicitly represents "peak human performance," mandating that human operators be credentialed experts with a documented history of >500 total prostate biopsies and >200 cognitive fusion targeted cases.
To eliminate performance bias and placebo effects on patient-reported outcomes (such as procedural anxiety and pain), the trial implements a strict single-blind (patient-blinded) protocol. A high surgical drape and noise-canceling headphones are utilized to completely mask the distinct motor operations of the robotic platform from the participant.
Furthermore, to mitigate the inherent recruitment fatigue associated with this highly specific demographic, the study incorporates a Bayesian sequential monitoring framework. An independent Data Safety Monitoring Board (DSMB) will evaluate Posterior Probability and Predictive Probability of Success (PPOS) at predefined interim looks (N=200, 300, and 400). This allows the trial to be halted early for either overwhelming efficacy or objective futility. By strictly targeting the "stress test" population, ROBUST seeks to provide Level 1 evidence for a risk-stratified precision diagnostic pathway, evaluating whether high-cost robotic technology is an absolute clinical necessity for men with obesity.
- Conditions
- Prostate Biopsy
- Being tested
- Robotic-Assisted Fusion Biopsy, Expert Cognitive Fusion Biopsy
- Keywords
- prostate biopsy, targeted biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Fusion BiopsyProcedure or surgery
Participants in this arm will undergo a transperineal prostate biopsy utilizing a dedicated robotic fusion platform. The system features a mechanical arm or rigid fixator that completely locks the ultrasound probe and needle guide into a pre-planned coordinate trajectory. This mechanical stabilization uncouples the needle guide from manual human force, eliminating operator hand tremor and the "fulcrum effect" caused by deep pelvic adiposity. The urologist will obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3) using the robotic interface, followed by a standard systematic biopsy. To prevent performance bias and placebo effects, participants will be blinded to the intervention using a high surgical drape and noise-canceling headphones.
Expert Cognitive Fusion BiopsyProcedure or surgery
Participants in this arm will undergo a standard manual transperineal prostate biopsy. To represent "peak human performance," the procedure will be performed exclusively by an expert urologist credentialed with a documented history of >500 total prostate biopsies, including >200 cognitive fusion targeted cases. The operator will mentally register the MRI lesion onto the real-time ultrasound image using anatomical landmarks, without the aid of any software overlay or robotic mechanical stabilization. The urologist will manually obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3), followed by a standard systematic biopsy. To maintain the single-blind study design, participants will be shielded by a surgical drape and wear noise-canceling headphones.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Fusion Biopsy | Experimental | Robotic-Assisted Fusion Biopsy Receives: Procedure: Robotic-Assisted Fusion Biopsy |
| Expert Cognitive Fusion Biopsy | Active comparator | Expert Cognitive Fusion Biopsy Receives: Procedure: Expert Cognitive Fusion 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 (csPCa) by Targeted Biopsy
The primary efficacy endpoint is the proportion of participants in the intention-to-treat (ITT) population diagnosed with clinically significant prostate cancer (csPCa) specifically from the targeted biopsy cores. csPCa is strictly defined histopathologically as International Society of Urological Pathology (ISUP) Grade Group 2 or higher (Gleason score 3+4=7 or greater).
Measured: Up to 30 days post-procedure (at the time of final pathology report)
Secondary outcomes (3)
Detection Rate of Any Prostate Cancer by Targeted Biopsy
The proportion of participants in whom any prostate cancer, defined as ISUP Grade Group 1 or higher (Gleason score 3+3=6 or greater), is detected specifically from the targeted biopsy cores.
Measured: Up to 30 days post-procedure
Detection Rate of csPCa by Combined Biopsy
The proportion of participants diagnosed with clinically significant prostate cancer (ISUP Grade Group 2 or higher) when combining the pathological results from both the targeted biopsy cores and the standard systematic biopsy cores.
Measured: Up to 30 days post-procedure
Pathological Upgrade Rate
The proportion of participants in whom the targeted biopsy cores detect a higher ISUP Grade Group of prostate cancer compared to the ISUP Grade Group detected by the background systematic biopsy cores in the same patient.
Measured: Up to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- haifeng wang, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600216
- Sponsor's protocol ID
- 20260146
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the primary publication, along with the study protocol and statistical analysis plan (SAP), will be made available to qualified scientific researchers. Data will be available beginning 6 months and ending 36 months following article publication. To gain access, researchers must submit a methodologically sound study proposal to the corresponding authors. Data sharing will be strictly subject to the execution of a formal data use agreement and must fully comply with local institutional review board (IRB) requirements and national data security regulations regarding cross-border data transfer.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Superiority Trial Comparing Robotic-Assisted Versus Expert Cognitive Fusion Prostate Biopsy in Obese Men
- ClinicalTrials.gov ID
- NCT07600216
- Acronym / sponsor ID
- 20260146
- Conditions
- Prostate Biopsy
- Keywords
- prostate biopsy, targeted biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 20 May 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.
The trial aims to find out if using a robotic system to help perform prostate biopsies is better than having a highly experienced doctor perform the biopsy by hand in men with a high Body Mass Index (BMI).
While MRI-guided prostate biopsies are highly effective, carrying them out in men with obesity can be physically challenging for doctors. Extra pelvic tissue increases the depth the biopsy needle must travel and makes it difficult to manually hold the ultrasound probe perfectly steady. This physical difficulty might cause doctors to miss some aggressive prostate cancers.
This study tests whether a robotic arm-which completely locks the biopsy needle on target and eliminates human hand tremors-can improve cancer detection. The study will enroll up to 570 men with high BMI who have suspicious areas on their prostate MRI. Participants will be randomly assigned to receive either a robotic-assisted biopsy or a standard manual biopsy performed by an expert urologist.
To ensure the results are completely unbiased, participants will not know which method is being used on them. They will be placed behind a surgical drape and wear noise-canceling headphones playing music during the procedure to block out the sounds of the robotic motors. The main goal is to see if the robotic method safely and significantly increases the detection rate of clinically significant prostate cancer in this specific group of patients.
Detailed description
The integration of multiparametric magnetic resonance imaging (mpMRI) with transperineal targeted biopsy has established a new standard for prostate cancer diagnosis. However, clinical evidence, including findings from the previous IMAGINATION trial, suggests that the diagnostic accuracy of manual targeted biopsy techniques degrades significantly in patients with high Body Mass Index (BMI).
Deep perineal adiposity creates a "hostile anatomical environment." It increases the skin-to-apex distance and introduces a "fulcrum effect," where the extensive soft tissue acts as a pivot point that amplifies manual tremors and restricts the operator's physical ability to steer the transperineal probe accurately. This mechanical barrier contributes to the "Obesity Paradox," wherein men with obesity face a higher risk of harboring undiagnosed, advanced high-grade prostate cancer.
The ROBUST (Robotic Optimization for Biopsy Under Substantial Tissue) trial is an investigator-initiated, international, multicenter, randomized controlled trial designed to determine if robotic stabilization can serve as a "technical equalizer" for this specific anatomical challenge.
Unlike conventional device trials, ROBUST utilizes a Bayesian adaptive hierarchical non-inferiority to superiority design. It aims to test whether robotic-assisted fusion biopsy is strictly non-inferior (with a -5% margin), and subsequently superior, to expert cognitive fusion biopsy. To rigorously isolate the impact of mechanical stabilization from operator inexperience, the control arm explicitly represents "peak human performance," mandating that human operators be credentialed experts with a documented history of >500 total prostate biopsies and >200 cognitive fusion targeted cases.
To eliminate performance bias and placebo effects on patient-reported outcomes (such as procedural anxiety and pain), the trial implements a strict single-blind (patient-blinded) protocol. A high surgical drape and noise-canceling headphones are utilized to completely mask the distinct motor operations of the robotic platform from the participant.
Furthermore, to mitigate the inherent recruitment fatigue associated with this highly specific demographic, the study incorporates a Bayesian sequential monitoring framework. An independent Data Safety Monitoring Board (DSMB) will evaluate Posterior Probability and Predictive Probability of Success (PPOS) at predefined interim looks (N=200, 300, and 400). This allows the trial to be halted early for either overwhelming efficacy or objective futility. By strictly targeting the "stress test" population, ROBUST seeks to provide Level 1 evidence for a risk-stratified precision diagnostic pathway, evaluating whether high-cost robotic technology is an absolute clinical necessity for men with obesity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Fusion Biopsy | Experimental | Procedure: Robotic-Assisted Fusion BiopsyRobotic-Assisted Fusion Biopsy |
| Expert Cognitive Fusion Biopsy | Active comparator | Procedure: Expert Cognitive Fusion BiopsyExpert Cognitive Fusion Biopsy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40 years.
- Serum PSA levels between 4 and 20 ng/ml and/or abnormal digital rectal examination (DRE).
- High Body Mass Index (BMI): defined as ≥ 28 kg/m ² for Asian cohorts and ≥ 30 kg/m ² for Non-Asian cohorts.
- MRI-Positive: Presence of at least one suspicious lesion (PI-RADS score ≥ 3) on mpMRI.
- Fitness for transperineal biopsy under local anaesthesia or conscious sedation.
Key exclusion criteria (4 listed)
- Prior treatment for prostate cancer.
- History of major anorectal surgery preventing safe transperineal probe insertion.
- Contraindications to MRI.
- Negative screening MRI (PI-RADS 1-2).
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 |
|---|---|---|
| Robotic-Assisted Fusion BiopsyParticipants in this arm will undergo a transperineal prostate biopsy utilizing a dedicated robotic fusion platform. The system features a mechanical arm or rigid fixator that completely locks the ultrasound probe and needle guide into a pre-planned coordinate trajectory. This mechanical stabilization uncouples the needle guide from manual human force, eliminating operator hand tremor and the "fulcrum effect" caused by deep pelvic adiposity. The urologist will obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3) using the robotic interface, followed by a standard systematic biopsy. To prevent performance bias and placebo effects, participants will be blinded to the intervention using a high surgical drape and noise-canceling headphones. | Procedure or surgery | Robotic-Assisted Fusion Biopsy |
| Expert Cognitive Fusion BiopsyParticipants in this arm will undergo a standard manual transperineal prostate biopsy. To represent "peak human performance," the procedure will be performed exclusively by an expert urologist credentialed with a documented history of >500 total prostate biopsies, including >200 cognitive fusion targeted cases. The operator will mentally register the MRI lesion onto the real-time ultrasound image using anatomical landmarks, without the aid of any software overlay or robotic mechanical stabilization. The urologist will manually obtain 3 to 4 targeted cores per MRI-visible lesion (PI-RADS ≥ 3), followed by a standard systematic biopsy. To maintain the single-blind study design, participants will be shielded by a surgical drape and wear noise-canceling headphones. | Procedure or surgery | Expert Cognitive Fusion Biopsy |
Primary outcome
Detection Rate of Clinically Significant Prostate Cancer (csPCa) by Targeted Biopsy
Time frame: Up to 30 days post-procedure (at the time of final pathology report)
The primary efficacy endpoint is the proportion of participants in the intention-to-treat (ITT) population diagnosed with clinically significant prostate cancer (csPCa) specifically from the targeted biopsy cores. csPCa is strictly defined histopathologically as International Society of Urological Pathology (ISUP) Grade Group 2 or higher (Gleason score 3+4=7 or greater).
3 secondary outcomes
Detection Rate of Any Prostate Cancer by Targeted Biopsy
Time frame: Up to 30 days post-procedure
Detection Rate of csPCa by Combined Biopsy
Time frame: Up to 30 days post-procedure
Pathological Upgrade Rate
Time frame: Up to 30 days post-procedure
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the primary publication, along with the study protocol and statistical analysis plan (SAP), will be made available to qualified scientific researchers. Data will be available beginning 6 months and ending 36 months following article publication. To gain access, researchers must submit a methodologically sound study proposal to the corresponding authors. Data sharing will be strictly subject to the execution of a formal data use agreement and must fully comply with local institutional review board (IRB) requirements and national data security regulations regarding cross-border data transfer.
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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.
haifeng wang principal investigator
Shanghai East Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Fusion Biopsy and Expert Cognitive Fusion Biopsy in people with Prostate Biopsy, run by Shanghai East Hospital.
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 5 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Qiang Li (+8613801602220, liqressh@hotmail.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 (csPCa) by Targeted Biopsy (time frame: Up to 30 days post-procedure (at the time of final pathology report)). 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 24 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.