PSA ProgressionNCT07516223
MRI-Assisted Guidance for Non-Essential Tissue Sampling
A study testing Paired Prostate Biopsy Cohort (TB + SB) in people with PSA Progression and PSA, run by Shanghai East Hospital at 1 site in China.
Trial summary
The study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer. Currently, when a man has a suspicious MRI scan, standard medical guidelines recommend a "combined biopsy." This means the urologist performs a Targeted Biopsy (taking… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- PSA Progression, PSA
- What is being tested?
- Paired Prostate Biopsy Cohort (TB + SB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,235 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2026to 5 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11.
- Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.
Who cannot join
- History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months.
- Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory).
- Contraindications to MRI (e.g., incompatible implants, severe renal impairment).
- Active urinary tract infection or acute prostatitis.
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
Shanghai east hospital
Shanghai
Shanghai East hospital ethics committee, 86-021-38804518, siwei_bao@163.com
About this study
Official title: MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study
The study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer.
Currently, when a man has a suspicious MRI scan, standard medical guidelines recommend a "combined biopsy." This means the urologist performs a Targeted Biopsy (taking 3-5 tissue samples directly from the suspicious area seen on the MRI) followed immediately by a Systematic Biopsy (taking 12 additional samples blindly from the rest of the prostate). While this combined approach maximizes cancer detection, the 12 extra needles from the systematic biopsy increase the risk of bleeding, pain, and urinary infection.
Read more
Researchers believe that for men who already have a very high prostate-specific antigen (PSA) level and a highly suspicious MRI, the targeted biopsy alone might be enough to detect any dangerous cancer. In these high-risk men, the extra 12 systematic needles might offer little to no additional benefit ("diminishing returns").
In this study, 850 men will undergo the standard combined biopsy procedure. However, to test the researchers' theory with extreme precision, the tissue samples from the Targeted Biopsy and the Systematic Biopsy will be placed into completely separate, uniquely barcoded jars (the "One Core, One Jar" spatial mapping protocol). The pathologist will examine each tissue sample independently, without knowing which method was used to collect it.
By comparing the results within each patient, the study will determine exactly how many dangerous cancers were found exclusively by the systematic biopsy. If this number is clinically negligible (less than 5%) in men with high PSA levels, it will prove that the 12 extra needles are unnecessary for this specific group.
The ultimate goal of the trial is to safely "de-escalate" prostate cancer diagnostics-sparing high-risk men from the physical trauma, complications, and costs of unnecessary systematic sampling, while ensuring no dangerous cancers are missed.
- Conditions
- PSA Progression, PSA
- Being tested
- Paired Prostate Biopsy Cohort (TB + SB)
- Keywords
- prostate biopsy, targeted biopsy, systematic biopsy, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paired Prostate Biopsy Cohort (TB + SB)Procedure or surgery
All enrolled participants (PSA ≥ 4.0 ng/mL and PI-RADS 4-5 lesions) will undergo a standardized paired biopsy procedure during a single clinical session. Step 1: MRI-Targeted Biopsy (TB) of the index lesion(s). Step 2: A standard 12-core Systematic Biopsy (SB) covering the peripheral and transition zones. To allow for independent and unbiased pathological evaluation, biopsy cores will be strictly handled using a high-fidelity "One Core, One Jar" spatial mapping protocol. The diagnostic utility (incremental detection rate) of the systematic biopsy will be compared within-patient and further analyzed across two pre-specified risk strata (PSA 4-20 ng/mL vs. PSA > 20 ng/mL).
| Study group | Role | What they receive |
|---|---|---|
| Paired Prostate Biopsy Cohort (TB + SB) | Experimental | Not described Receives: Procedure: Paired Prostate Biopsy Cohort (TB + SB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy
- Absolute Marker Framework: Stratified by serum PSA (> 20 ng/ml vs. 4-20 ng/ml).
- Relative Marker Framework: Stratified by PSA Density (PSAD), utilizing a pre-specified threshold (e.g., ≥ 0.15 ng/ml² vs. < 0.15 ng/ml²).
Both frameworks aim to validate a 'stopping rule' for systematic biopsy."
Measured: within 2 weeks after biopsy
Secondary outcomes (4)
Rate of Treatment Management Change
The proportion of patients in whom the addition of Systematic Biopsy findings alters the recommended treatment plan compared to the plan based on Targeted Biopsy findings alone
Measured: within 2 weeks after biopsy
Pathological Upgrading Rate
The proportion of patients in whom Systematic Biopsy detects a higher ISUP Grade Group than that detected by Targeted Biopsy.
Measured: Within 2 weeks after biopsy
Diagnostic Accuracy Metrics
Sensitivity, Specificity, NPV, and PPV of the "Target-Only" strategy, using the "Combined Biopsy" result as the composite reference standard.
Measured: within 2 weeks after biopsy
Virtual Safety Analysis
A modelled analysis estimating the reduction in adverse events (e.g., haematuria, retention) if Systematic Biopsy had been omitted in the Experimental Stratum. This is calculated based on the "Number of Cores Saved" multiplied by per-core complication risk coefficients derived from trial safety data.
Measured: within 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 posted7 Apr 2026
- Study start5 Apr 2026
- Primary completion5 Apr 2028 (estimated)
- Study completion5 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSA ProgressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516223
- Sponsor's protocol ID
- 2026044
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- MRI-Assisted Guidance for Non-Essential Tissue Sampling (MAGNET): an Investigator-initiated, International, Multicentre, Prospective, Pairedcohort, Diagnostic Utility Study
- ClinicalTrials.gov ID
- NCT07516223
- Acronym / sponsor ID
- 2026044
- Conditions
- PSA Progression, PSA
- Keywords
- prostate biopsy, targeted biopsy, systematic biopsy, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,235 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 5 Apr 2026 (actual)
- Primary completion
- 5 Apr 2028 (estimated)
- Study completion
- 5 May 2028 (estimated)
- First posted
- 7 Apr 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 study aims to determine if a less painful and less invasive prostate biopsy approach is safe for certain men with a high risk of prostate cancer.
Currently, when a man has a suspicious MRI scan, standard medical guidelines recommend a "combined biopsy." This means the urologist performs a Targeted Biopsy (taking 3-5 tissue samples directly from the suspicious area seen on the MRI) followed immediately by a Systematic Biopsy (taking 12 additional samples blindly from the rest of the prostate). While this combined approach maximizes cancer detection, the 12 extra needles from the systematic biopsy increase the risk of bleeding, pain, and urinary infection.
Researchers believe that for men who already have a very high prostate-specific antigen (PSA) level and a highly suspicious MRI, the targeted biopsy alone might be enough to detect any dangerous cancer. In these high-risk men, the extra 12 systematic needles might offer little to no additional benefit ("diminishing returns").
In this study, 850 men will undergo the standard combined biopsy procedure. However, to test the researchers' theory with extreme precision, the tissue samples from the Targeted Biopsy and the Systematic Biopsy will be placed into completely separate, uniquely barcoded jars (the "One Core, One Jar" spatial mapping protocol). The pathologist will examine each tissue sample independently, without knowing which method was used to collect it.
By comparing the results within each patient, the study will determine exactly how many dangerous cancers were found exclusively by the systematic biopsy. If this number is clinically negligible (less than 5%) in men with high PSA levels, it will prove that the 12 extra needles are unnecessary for this specific group.
The ultimate goal of the trial is to safely "de-escalate" prostate cancer diagnostics-sparing high-risk men from the physical trauma, complications, and costs of unnecessary systematic sampling, while ensuring no dangerous cancers are missed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired Prostate Biopsy Cohort (TB + SB) | Experimental | Procedure: Paired Prostate Biopsy Cohort (TB + SB) |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11.
- Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent.
Key exclusion criteria (4 listed)
- History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months.
- Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory).
- Contraindications to MRI (e.g., incompatible implants, severe renal impairment).
- Active urinary tract infection or acute prostatitis.
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 |
|---|---|---|
| Paired Prostate Biopsy Cohort (TB + SB)All enrolled participants (PSA ≥ 4.0 ng/mL and PI-RADS 4-5 lesions) will undergo a standardized paired biopsy procedure during a single clinical session. Step 1: MRI-Targeted Biopsy (TB) of the index lesion(s). Step 2: A standard 12-core Systematic Biopsy (SB) covering the peripheral and transition zones. To allow for independent and unbiased pathological evaluation, biopsy cores will be strictly handled using a high-fidelity "One Core, One Jar" spatial mapping protocol. The diagnostic utility (incremental detection rate) of the systematic biopsy will be compared within-patient and further analyzed across two pre-specified risk strata (PSA 4-20 ng/mL vs. PSA > 20 ng/mL). | Procedure or surgery | Paired Prostate Biopsy Cohort (TB + SB) |
Primary outcome
The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy
Time frame: within 2 weeks after biopsy
1. Absolute Marker Framework: Stratified by serum PSA (> 20 ng/ml vs. 4-20 ng/ml). 2. Relative Marker Framework: Stratified by PSA Density (PSAD), utilizing a pre-specified threshold (e.g., ≥ 0.15 ng/ml² vs. < 0.15 ng/ml²). Both frameworks aim to validate a 'stopping rule' for systematic biopsy."
4 secondary outcomes
Rate of Treatment Management Change
Time frame: within 2 weeks after biopsy
Pathological Upgrading Rate
Time frame: Within 2 weeks after biopsy
Diagnostic Accuracy Metrics
Time frame: within 2 weeks after biopsy
Virtual Safety Analysis
Time frame: within 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 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Paired Prostate Biopsy Cohort (TB + SB) in people with PSA Progression and PSA, 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 2 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: looking for participants now, 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.
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 Shanghai East hospital ethics committee (86-021-38804518, siwei_bao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the Incremental Detection Rate (IDR) of clinically significant prostate cancer provided by systematic biopsy (time frame: within 2 weeks after 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 24 Jun 2026.