Prostate CancerPROMUCNCT04953351
MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy
A study testing Cognitive registration targeted biopsy and TRUS-system biopsy and MRI-ultrasound fusion targeted biopsy and TRUS-system 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
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cognitive registration targeted biopsy and TRUS-system biopsy and MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Jul 2022
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum PSA ≤ 20 ng/ml within the previous 3 months;
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
- No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- mpMRI PI-RADS V2.1 score ≥3；
- Able to provide written informed consent.
Who cannot join
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy;
- Men in whom artifact would reduce the quality of the MRI.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000
About this study
Official title: PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
Read the detailed description
Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).
With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Cognitive registration targeted biopsy and TRUS-system biopsy, MRI-ultrasound fusion targeted biopsy and TRUS-system 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 registration targeted biopsy and TRUS-system biopsyProcedure or surgery
Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
MRI-ultrasound fusion targeted biopsy and TRUS-system biopsyProcedure or surgery
MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.
| Study group | Role | What they receive |
|---|---|---|
| cognitive registration targeted biopsy | Experimental | Not described Receives: Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy |
| MRI-ultrasound fusion targeted biopsy | Active comparator | Not described Receives: Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rates of clinically significant PCa in FUS-TB and COG-TB
Measured: When histology results available, at an expected average of 30 days post-biopsy
Secondary outcomes (6)
Detection rates of clinically insignificant PCa in FUS-TB and COG-TB
Measured: When histology results available, at an expected average of 30 days post-biopsy
Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5
Measured: When histology results available, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Measured: When histology results available, at an expected average of 30 days post-biopsy
Biopsy-related adverse events
Measured: 30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading
Measured: 60 days post biopsy
Detection rates of clinically significant PCa in SB
Measured: When histology results available, at an expected average of 30 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionJul 2022 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Hongqian Guo, Guo, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953351
- Sponsor's protocol ID
- MRITB-202003
- Acronym
- PROMUC
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMUC Trial-Comparison of Magnetic Resonance Imaging-Ultrasound Fusion and Cognitive Registration in MR-targeted Prostate Biopsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04953351
- Acronym / sponsor ID
- PROMUC / MRITB-202003
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 Jul 2021 (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 randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
Detailed description
Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).
With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive registration targeted biopsy | Experimental | Procedure: Cognitive registration targeted biopsy and TRUS-system biopsy |
| MRI-ultrasound fusion targeted biopsy | Active comparator | Procedure: MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum PSA ≤ 20 ng/ml within the previous 3 months;
- Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
- No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- mpMRI PI-RADS V2.1 score ≥3；
Key exclusion criteria (5 listed)
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy;
- Men in whom artifact would reduce the quality of the MRI.
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 registration targeted biopsy and TRUS-system biopsyCognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores. | Procedure or surgery | cognitive registration targeted biopsy |
| MRI-ultrasound fusion targeted biopsy and TRUS-system biopsyMRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores. | Procedure or surgery | MRI-ultrasound fusion targeted biopsy |
Primary outcome
Detection rates of clinically significant PCa in FUS-TB and COG-TB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
6 secondary outcomes
Detection rates of clinically insignificant PCa in FUS-TB and COG-TB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Biopsy-related adverse events
Time frame: 30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading
Time frame: 60 days post biopsy
Detection rates of clinically significant PCa in SB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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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.
Hongqian Guo, Guo study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 registration targeted biopsy and TRUS-system biopsy and MRI-ultrasound fusion targeted biopsy and TRUS-system 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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 Hongqian Guo, PhD (8613605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rates of clinically significant PCa in FUS-TB and COG-TB (time frame: When histology results available, at an expected average of 30 days 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 7 Jul 2021.