Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the ProstateNCT04183699
Optimizing the Number of Systematic COres During a MRI Target Biopsy
A study testing Prostate biopsy in people with Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
- What is being tested?
- Prostate biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2019to 3 Jun 2026
- 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
- Male patients, aged between 18 and 80 years old with suspicion of prostate cancer
- Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3)
- Serum PSA ≤ 20ng/ml
- Suspected stage ≤ T2 on rectal examination (organ confined prostate)
- Fit to undergo a prostate biopsy
- Able to understand and willing to sign a written informed consent document
Who cannot join
- Prior positive prostate biopsy
- Prior treatment of the prostate
- Prostate volume <30 ml at mpMRI of the prostate
- More than one lesion at mpMRI of the prostate
- Contraindication to prostate biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.
- Conditions
- Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
- Being tested
- Prostate biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsyDiagnostic test
MRI-targeted + systematic random prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| MRI targeted + systematic random biopsy | Experimental | Not described Receives: Diagnostic Test: Prostate 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 with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy
The proportion of men diagnosed with csPCa according to the addition of any single systematic core
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start6 Jun 2019
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Why it stopped: The study was prematurely terminated due to recruitment challenges, insufficient enrollment, operational constraints, and the inability to generate a sufficiently robust dataset to address the study objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the ProstateStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Alberto Briganti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183699
- Sponsor's protocol ID
- SCOT
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
- ClinicalTrials.gov ID
- NCT04183699
- Acronym / sponsor ID
- SCOT
- Conditions
- Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to recruitment challenges, insufficient enrollment, operational constraints, and the inability to generate a sufficiently robust dataset to address the study objectives
- Enrolment
- 126 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 3 Dec 2019 (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 is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI targeted + systematic random biopsy | Experimental | Diagnostic Test: Prostate 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)
- Male patients, aged between 18 and 80 years old with suspicion of prostate cancer
- Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3)
- Serum PSA ≤ 20ng/ml
- Suspected stage ≤ T2 on rectal examination (organ confined prostate)
- Fit to undergo a prostate biopsy
Key exclusion criteria (5 listed)
- Prior positive prostate biopsy
- Prior treatment of the prostate
- Prostate volume <30 ml at mpMRI of the prostate
- More than one lesion at mpMRI of the prostate
- Contraindication to prostate biopsy
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 |
|---|---|---|
| Prostate biopsyMRI-targeted + systematic random prostate biopsy | Diagnostic test | MRI targeted + systematic random biopsy |
Primary outcome
Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
Time frame: through study completion, an average of 1 year
Proportion of patients diagnosed with csPCa with 6-core vs. 20-core systematic biopsy during a MRI target biopsy
1 secondary outcome
Incremental value of any additional systematic and targeted core on the detection rate of clinically significant prostate cancer during MRI target biopsy
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to recruitment challenges, insufficient enrollment, operational constraints, and the inability to generate a sufficiently robust dataset to address the study objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy in people with Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate, run by IRCCS San Raffaele at 1 site in Italy.
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: stopped early, as of the sponsor's last update on 10 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 Italy. 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?
The study was stopped early (reason given: The study was prematurely terminated due to recruitment challenges, insufficient enrollment, operational constraints, and the inability to generate a sufficiently robust dataset to address the study objectives). Results are not available in the source record.
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?
Detection rate of clinically significant prostate cancer with 6-core vs. 20-core systematic biopsy during a MRI target biopsy (time frame: through study completion, an average of 1 year). 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 10 Jun 2026.