Prostate Cancer (Diagnosis)INSIGHT-PCaNCT07398690
INSIGHT-PCa: MRI- and PHI-Guided Risk-Adapted Strategy for Prostate Cancer Diagnosis
A study testing Diagnostic Procedure in people with Prostate Cancer (Diagnosis) and Prostate Cancer, run by In Gab Jeong, MD at 1 site in South Korea.
Trial summary
Prostate cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis), Prostate Cancer
- What is being tested?
- Diagnostic Procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,432 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2026to 31 Dec 2029
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged 20 years or older
- Serum PSA ≥3.0 ng/mL and ≤20.0 ng/mL and/or abnormal digital rectal -examination
- Biopsy-naïve
- Clinical stage ≤T2 disease
- Ability to provide written informed consent
Who cannot join
- Previous prostate biopsy or prostate cancer treatment
- Use of 5-alpha reductase inhibitors within 6 months
- Acute prostatitis or urinary tract infection within 3 months
- Contraindications to MRI
- Contraindications to prostate biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
In Gab Jeong, MD, PhD, 82-2-3010-5892, igjeong@amc.seoul.kr
About this study
Official title: Integrated Noninvasive Strategy Guided by Multiparametric MRI and the Prostate Health Index for Risk-Adapted Detection of Clinically Significant Prostate Cancer: A Multicenter Randomized Controlled Trial (INSIGHT-PCa Study)
Prostate cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI findings-remain uncertain.
The INSIGHT-PCa study is a prospective, multicenter, randomized controlled trial designed to evaluate whether a risk-adapted diagnostic strategy integrating multiparametric MRI and the Prostate Health Index (PHI) can reduce unnecessary prostate biopsies without compromising detection of clinically significant prostate cancer.
Participants with suspected prostate cancer will be randomized to either a standard MRI-based diagnostic pathway or an optimized strategy in which biopsy decisions are guided by combined MRI findings and PHI density. The primary objective is to demonstrate non-inferiority in the detection of clinically significant prostate cancer while reducing biopsy utilization and biopsy-related adverse events.
Read the detailed description
This multicenter, prospective, randomized controlled trial will enroll 1,432 biopsy-naïve men with suspected prostate cancer across five tertiary referral centers in Korea. Eligible participants will have a serum prostate-specific antigen (PSA) level between 3 and 20 ng/mL.
Participants will be randomized in a 1:1 ratio to either a control group receiving a standard MRI-based diagnostic pathway or an experimental group managed using an optimized, risk-adapted strategy integrating multiparametric MRI and the Prostate Health Index.
In the control group, men with PI-RADS scores of 1-2 will undergo systematic 12-core transrectal ultrasound-guided biopsy, while those with PI-RADS scores of 3-5 will receive combined MRI-targeted and systematic biopsy.
In the experimental group, men with PI-RADS scores of 1-3 will undergo biopsy only if the PHI density is ≥0.80; biopsy will be omitted in those with lower PHI density and replaced by active surveillance. Men with PI-RADS scores of 4-5 will undergo MRI-targeted biopsy alone.
The trial is designed as a non-inferiority study. The primary endpoint is the proportion of clinically significant prostate cancer (Gleason score ≥3+4). Secondary endpoints include detection of clinically insignificant cancer, biopsy omission rates, biopsy-related adverse events, and cumulative detection of clinically significant prostate cancer during 24 months of follow-up.
- Conditions
- Prostate Cancer (Diagnosis), Prostate Cancer
- Being tested
- Diagnostic Procedure
- Keywords
- Prostate cancer, Multiparametric MRI, Prostate Health Index, Risk-adapted diagnosis, MRI-targeted biopsy, Biopsy reduction
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ProcedureDiagnostic test
PI-RADS 1-3:
PHI density <0.80 → Biopsy omitted; active surveillance PHI density ≥0.80 → Systematic 12-core TRUS-guided biopsy PI-RADS 4-5: MRI-targeted biopsy alone
Diagnostic ProcedureDiagnostic test
PI-RADS 1-2: Systematic 12-core TRUS-guided biopsy PI-RADS 3-5: Combined MRI-targeted biopsy and systematic 12-core biopsy
| Study group | Role | What they receive |
|---|---|---|
| Standard MRI-Based Diagnostic Strategy (Control) | Active comparator | Conventional Standard Diagnostic Procedure Receives: Diagnostic Test: Diagnostic Procedure |
| INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental) | Experimental | Experimental Diagnostic Procedure Receives: Diagnostic Test: Diagnostic Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of clinically significant prostate cancer
Proportion of participants diagnosed with clinically significant prostate cancer (Gleason score ≥3+4)
Measured: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Secondary outcomes (6)
Detection of clinically insignificant prostate cancer (Gleason score 6)
Measured: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Proportion of participants in whom prostate biopsy is omitted
Measured: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Total number of biopsy cores obtained
Measured: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Biopsy-related adverse events (pain, infection, bleeding)
Measured: Within 30 days after prostate biopsy
Cumulative detection of clinically significant prostate cancer over 24 months
Measured: Over 24 months of follow-up
Gleason grade upgrading in participants undergoing radical prostatectomy
Measured: At the time of radical prostatectomy (within 12 months of diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start9 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Diagnosis)Studies 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
- None (open label)
- Enrolment
- 1,432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- In Gab Jeong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare (Republic of Korea)
- Responsible party
- Sponsor-investigator, In Gab Jeong, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398690
- Sponsor's protocol ID
- AMCURO- 2026-1
- Acronym
- INSIGHT-PCa
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
PubMed 25626035Hugosson J, Mansson M, Wallstrom J, Axcrona U, Carlsson SV, Egevad L, Geterud K, Khatami A, Kohestani K, Pihl CG, Socratous A, Stranne J, Godtman RA, Hellstrom M; GOTEBORG-2 Trial Investigators. Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med. 2022 Dec 8;387(23):2126-2137. doi: 10.1056/NEJMoa2209454.
PubMed 36477032Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.
PubMed 39321360Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
PubMed 34237810Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.
PubMed 32130814
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Noninvasive Strategy Guided by Multiparametric MRI and the Prostate Health Index for Risk-Adapted Detection of Clinically Significant Prostate Cancer: A Multicenter Randomized Controlled Trial (INSIGHT-PCa Study)
- ClinicalTrials.gov ID
- NCT07398690
- Acronym / sponsor ID
- INSIGHT-PCa / AMCURO- 2026-1
- Conditions
- Prostate Cancer (Diagnosis), Prostate Cancer
- Keywords
- Prostate cancer, Multiparametric MRI, Prostate Health Index, Risk-adapted diagnosis, MRI-targeted biopsy, Biopsy reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,432 participants (estimated)
- Lead sponsor
- In Gab Jeong, MDUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare (Republic of Korea)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Feb 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 cancer diagnosis based on systematic or MRI-targeted biopsy is associated with substantial overdiagnosis and unnecessary invasive procedures. Although multiparametric MRI improves detection of clinically significant prostate cancer, optimal criteria for biopsy omission-particularly in men with equivocal MRI findings-remain uncertain.
The INSIGHT-PCa study is a prospective, multicenter, randomized controlled trial designed to evaluate whether a risk-adapted diagnostic strategy integrating multiparametric MRI and the Prostate Health Index (PHI) can reduce unnecessary prostate biopsies without compromising detection of clinically significant prostate cancer.
Participants with suspected prostate cancer will be randomized to either a standard MRI-based diagnostic pathway or an optimized strategy in which biopsy decisions are guided by combined MRI findings and PHI density. The primary objective is to demonstrate non-inferiority in the detection of clinically significant prostate cancer while reducing biopsy utilization and biopsy-related adverse events.
Detailed description
This multicenter, prospective, randomized controlled trial will enroll 1,432 biopsy-naïve men with suspected prostate cancer across five tertiary referral centers in Korea. Eligible participants will have a serum prostate-specific antigen (PSA) level between 3 and 20 ng/mL.
Participants will be randomized in a 1:1 ratio to either a control group receiving a standard MRI-based diagnostic pathway or an experimental group managed using an optimized, risk-adapted strategy integrating multiparametric MRI and the Prostate Health Index.
In the control group, men with PI-RADS scores of 1-2 will undergo systematic 12-core transrectal ultrasound-guided biopsy, while those with PI-RADS scores of 3-5 will receive combined MRI-targeted and systematic biopsy.
In the experimental group, men with PI-RADS scores of 1-3 will undergo biopsy only if the PHI density is ≥0.80; biopsy will be omitted in those with lower PHI density and replaced by active surveillance. Men with PI-RADS scores of 4-5 will undergo MRI-targeted biopsy alone.
The trial is designed as a non-inferiority study. The primary endpoint is the proportion of clinically significant prostate cancer (Gleason score ≥3+4). Secondary endpoints include detection of clinically insignificant cancer, biopsy omission rates, biopsy-related adverse events, and cumulative detection of clinically significant prostate cancer during 24 months of follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard MRI-Based Diagnostic Strategy (Control) | Active comparator | Diagnostic Test: Diagnostic ProcedureConventional Standard Diagnostic Procedure |
| INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental) | Experimental | Diagnostic Test: Diagnostic ProcedureExperimental Diagnostic Procedure |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male, aged 20 years or older
- Serum PSA ≥3.0 ng/mL and ≤20.0 ng/mL and/or abnormal digital rectal -examination
- Biopsy-naïve
- Clinical stage ≤T2 disease
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Previous prostate biopsy or prostate cancer treatment
- Use of 5-alpha reductase inhibitors within 6 months
- Acute prostatitis or urinary tract infection within 3 months
- Contraindications to MRI
- Contraindications 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 |
|---|---|---|
| Diagnostic ProcedurePI-RADS 1-3: PHI density <0.80 → Biopsy omitted; active surveillance PHI density ≥0.80 → Systematic 12-core TRUS-guided biopsy PI-RADS 4-5: MRI-targeted biopsy alone | Diagnostic test | INSIGHT-PCa Risk-Adapted Diagnostic Strategy (Experimental) |
| Diagnostic ProcedurePI-RADS 1-2: Systematic 12-core TRUS-guided biopsy PI-RADS 3-5: Combined MRI-targeted biopsy and systematic 12-core biopsy | Diagnostic test | Standard MRI-Based Diagnostic Strategy (Control) |
Primary outcome
Detection of clinically significant prostate cancer
Time frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Proportion of participants diagnosed with clinically significant prostate cancer (Gleason score ≥3+4)
6 secondary outcomes
Detection of clinically insignificant prostate cancer (Gleason score 6)
Time frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Proportion of participants in whom prostate biopsy is omitted
Time frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Total number of biopsy cores obtained
Time frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)
Biopsy-related adverse events (pain, infection, bleeding)
Time frame: Within 30 days after prostate biopsy
Cumulative detection of clinically significant prostate cancer over 24 months
Time frame: Over 24 months of follow-up
Gleason grade upgrading in participants undergoing radical prostatectomy
Time frame: At the time of radical prostatectomy (within 12 months of diagnosis)
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 17 Mar 2026.
- Results publication: PubMed 25626035Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.
- Results publication: PubMed 36477032Hugosson J, Mansson M, Wallstrom J, Axcrona U, Carlsson SV, Egevad L, Geterud K, Khatami A, Kohestani K, Pihl CG, Socratous A, Stranne J, Godtman RA, Hellstrom M; GOTEBORG-2 Trial Investigators. Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med. 2022 Dec 8;387(23):2126-2137. doi: 10.1056/NEJMoa2209454.
- Results publication: PubMed 39321360Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.
- Results publication: PubMed 34237810Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
- Results publication: PubMed 32130814Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.
- Individual participant dataSharing planned: No
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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 Diagnostic Procedure in people with Prostate Cancer (Diagnosis) and Prostate Cancer, run by In Gab Jeong, MD at 1 site in South Korea.
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 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 17 Mar 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 South Korea. 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 In Gab Jeong, M.D. Ph.D (82-2-3010-5892, igjeong@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of clinically significant prostate cancer (time frame: From initial diagnostic evaluation to completion of diagnostic biopsy (up to 8 weeks)). 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 NCT07398690, which also lists 5 linked publications.
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 17 Mar 2026.