Prostate CancerNCT04320147
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer
A study testing Artemia in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Artemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2020to 1 Apr 2023
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men undergoing a first-time prostate biopsy to rule out cancer
- 2. Serum PSA ≥3ng/mL, ≤20ng/mL
- 3. Age≥50 years, ≤80 years
- 4. Clinical stage ≤T2c
- 5. Patients must be able to provide written informed consent.
Who cannot join
- 1. Patients has any prior needle biopsy of the prostate
- 2. Patients has a prior history of prostate cancer
- 3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- 4. Patients has a prior history of BPH operation
- 5. Patient with uncorrectable coagulopathies
- 6. Unable to tolerate a TRUS guided biopsy.
Show all 9Show fewer
- 7. Patients had 5-alpha reductase inhibitor in the past six months.
- 8. The patient has had a urinary tract infection or acute prostatitis in the last three months.
- 9. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR ≤50mls/min)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
In Gab Jeong, MD, 82-2-3010-5892, igjeong@amc.seoul.kr
In Gab Jeong, MD,PhD
About this study
Official title: MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
This paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.
Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.
Read the detailed description
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined.
- MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
- Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.
- Conditions
- Prostate Cancer
- Being tested
- Artemia
- Keywords
- Prostate cancer, MR-target Biopsy, Artemis
- Medical subject headings
- Prostatic Neoplasms, Severe combined immunodeficiency with sensitivity to ionizing radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtemiaDevice
Before prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
| Study group | Role | What they receive |
|---|---|---|
| MRI tartget biopsy | Experimental | 1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report. Receives: Device: Artemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
Measured: 2 week after the procedure
Secondary outcomes (8)
Proportion of clinically insignificant prostate cancer (Gleason score 6)
Measured: 2 week after the procedure
Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5
Measured: 2 week after the procedure
Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer
Measured: 2 week after the procedure
Cancer core length of the most involved biopsy core (maximum cancer core length, mm)
Measured: 2 week after the procedure
Proportion of men who go on to definitive local treatment or systemic treatment
Measured: 2 week after the procedure
Proportion of Gleason grade upgrading in men undergoing radical prostatectomy
Measured: 2 week after the surgery
Adverse events of post-biopsy (pain, infection, bleeding etc.)
Measured: 2 week after the procedure
Inter-observer variability among radiologists
Measured: 2 week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start23 Mar 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2023 (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 Asan Medical CenterThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bumjin Lim, Dalsan Yoo, Hyung Keun Park, Jun Hyuk Hong, Hanjong Ahn, Choung-Soo Kim, Kye Jin Park, Mi-Hyun Kim, Jeong Kon Kim
- Responsible party
- Principal investigator, In Gab Jeong, Asan Medical Center
- Investigators
- In Gab Jeong, MD, PhD, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320147
- Sponsor's protocol ID
- MRphI_AMC01
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
- ClinicalTrials.gov ID
- NCT04320147
- Acronym / sponsor ID
- MRphI_AMC01
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, MR-target Biopsy, Artemis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Bumjin Lim, Dalsan Yoo, Hyung Keun Park, Jun Hyuk Hong, Hanjong Ahn, Choung-Soo Kim, Kye Jin Park, Mi-Hyun Kim, Jeong Kon Kim
- Study start
- 23 Mar 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 Mar 2020 (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 paired cohort blinded trial aims to assess the detection rate of clinically significant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy. The investigators hypothesize that additional MRI-targeted biopsy will detect more clinically significant cancers than standard TRUS biopsy.
Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of clinically significant prostate cancer.
Detailed description
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score, MR targeted biopsy is determined.
- MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
- Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI tartget biopsy | Experimental | Device: Artemia1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist. 2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by urologist. This portion will be performed without information of the MRI report. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Men undergoing a first-time prostate biopsy to rule out cancer
- 2. Serum PSA ≥3ng/mL, ≤20ng/mL
- 3. Age≥50 years, ≤80 years
- 4. Clinical stage ≤T2c
- 5. Patients must be able to provide written informed consent.
Key exclusion criteria (9 listed)
- 1. Patients has any prior needle biopsy of the prostate
- 2. Patients has a prior history of prostate cancer
- 3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy
- 4. Patients has a prior history of BPH operation
- 5. Patient with uncorrectable coagulopathies
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 |
|---|---|---|
| ArtemiaBefore prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist. | Device | MRI tartget biopsy |
Primary outcome
Proportion of clinically significant prostate cancer (≥Gleason score 3+4)
Time frame: 2 week after the procedure
8 secondary outcomes
Proportion of clinically insignificant prostate cancer (Gleason score 6)
Time frame: 2 week after the procedure
Proportion of men in whom mpMRI score (PI-RADS) for suspicion of clinically significant cancer was 3, 4 or 5
Time frame: 2 week after the procedure
Correlation of prostate health index (Phi), phi density and MRI fusion Bx in predicting clinically significant prostate cancer
Time frame: 2 week after the procedure
Cancer core length of the most involved biopsy core (maximum cancer core length, mm)
Time frame: 2 week after the procedure
Proportion of men who go on to definitive local treatment or systemic treatment
Time frame: 2 week after the procedure
Proportion of Gleason grade upgrading in men undergoing radical prostatectomy
Time frame: 2 week after the surgery
Adverse events of post-biopsy (pain, infection, bleeding etc.)
Time frame: 2 week after the procedure
Inter-observer variability among radiologists
Time frame: 2 week after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- 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. This study is not recruiting at the moment.
In Gab Jeong, MD, PhD study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemia in people with Prostate Cancer, run by Asan Medical Center 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 9 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 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In Gab Jeong, MD, PhD (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?
Proportion of clinically significant prostate cancer (≥Gleason score 3+4) (time frame: 2 week after the procedure). 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 25 Mar 2020.