Randomized Controlled TrialNCT06402552
Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
A study testing bp-MRI prostate and mp-MRI prostate in people with Randomized Controlled Trial and Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Randomized Controlled Trial, Prostate Cancer, Magnetic Resonance Imaging
- What is being tested?
- bp-MRI prostate and mp-MRI prostate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2024to 31 Dec 2025
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥50 years of age
- Clinical suspicion of prostate cancer and indicated for prostate biopsy
- Serum Prostate-specific antigen (PSA) between 4~20 ng/mL
- Eligible for MRI study
- Digital rectal examination ≤ cT2 (organ-confined cancer)
- Able to provide written informed consent.
Who cannot join
- Prior prostate biopsy in the 6 months before screening visit
- Prior diagnosis of prostate cancer
- Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
- Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
- Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
- Patients have prior treatments for prostate cancers or any kinds of hormone therapy, immunotherapy, chemotherapy, radiation therapy of the pelvic cavity.
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- Patients' withdrawal of informed consents of this study
- Withdrawal criteria:
- Patients could not complete the scheduled MRI examinations
- MRI images of insufficient quality to localized csPCA or to exclude the presence of csPCA
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
See-Tong Pang, MD. PhD., 0975365572, jacobpang@cgmh.org.tw
See-Tong Pang, MD. PhD.
About this study
Official title: A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.
3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
Read more
3.2.2 Secondary endpoints:
- The proportion of men with a diagnosis of any PCa
- The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
- The proportion of men with a diagnosis of csPCa
- Only in targeted biopsy
- Only in systematic biopsy
- The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.
Read the detailed description
Study intervention MRI prostate Bi-parametric and multi-parametric MRI prostates can be performed using a 3.0 Tesla scanner with a pelvic phased array coil with or without contrast. MRI findings will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI will be reported by radiologists with experience in MRI prostate reporting. PI-RADS scores 3-5 will be regarded as suspicious, and targeted plus systematic biopsy will be performed.
Prostate biopsy In patients with suspicious lesion found on MRI (identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI), biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion, alone with 3 cores of systemic biopsy from right and left lobes respectively.
In those without identified suspicious lesions on MRI, a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia.
All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy. Targeted biopsies will be done by software-assisted MRI-USG fusion registration. Peri-biopsy antibiotics are given according to our clinical guidelines.
Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria, and clinically stable. They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications. All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology (ISUP) consensus. The study period ends after the first clinic follow-up.
In our medical research, the investigators prioritize protecting participant privacy and confidentiality. The investigators use unique research codes to anonymize personal details like names and IDs. The principal investigator keeps consultation results and diagnoses confidential, even in published research. Participants consent to have their records reviewed by authorized parties for legal and ethical compliance, with a promise of maintaining their anonymity. For safety, the investigators may inform participants' other doctors about their trial involvement to manage treatment interactions. Overall, these steps ensure participant privacy and safety throughout the research.
- Being tested
- bp-MRI prostate, mp-MRI prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bp-MRI prostateDiagnostic test
Biparametric MRI is considered less comprehensive compared to multiparametric MRI (mp-MRI), which includes additional parameters like dynamic contrast-enhanced MRI (DCE-MRI). However, bp-MRI offers a simpler, faster, and often less expensive alternative that still provides critical diagnostic information, particularly in the detection of clinically significant prostate cancer. It's commonly used where less comprehensive assessment is sufficient or in situations where contrast use is contraindicated.
mp-MRI prostateDiagnostic test
Multiparametric MRI is highly valued for its ability to improve the detection and characterization of clinically significant prostate cancer, aid in biopsy guidance, and help in treatment planning and monitoring. Its comprehensive approach provides crucial insights that are not as readily available through simpler imaging modalities like biparametric MRI (bp-MRI).
| Study group | Role | What they receive |
|---|---|---|
| prostate cancer | Experimental | Patients who are suspicious of prostate cancers with abnormal digital examination, or abnormal ultrasound and having a pre-MRI and were scheduled to receive prostate biopsy will be enrolled in this study. Patients will be randomized in a 1:1 manner to bp-MRI and mp-MRI. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) Receives: Diagnostic Test: bp-MRI prostate; Diagnostic Test: mp-MRI prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples
The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
Measured: 2-3 weeks
Secondary outcomes (1)
Prostate Cancer Diagnosis Rates and Specifics in Biopsy Methods
- The proportion of men with a diagnosis of any PCa
- The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
- The proportion of men with a diagnosis of csPCa
- Only in targeted biopsy
- Only in systematic biopsy
- The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402552
- Sponsor's protocol ID
- 202400317A3
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 10 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
- ClinicalTrials.gov ID
- NCT06402552
- Acronym / sponsor ID
- 202400317A3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 May 2024 (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.
3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial.
3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
3.2.2 Secondary endpoints:
- The proportion of men with a diagnosis of any PCa
- The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
- The proportion of men with a diagnosis of csPCa
- Only in targeted biopsy
- Only in systematic biopsy
- The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.
Detailed description
Study intervention MRI prostate Bi-parametric and multi-parametric MRI prostates can be performed using a 3.0 Tesla scanner with a pelvic phased array coil with or without contrast. MRI findings will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI will be reported by radiologists with experience in MRI prostate reporting. PI-RADS scores 3-5 will be regarded as suspicious, and targeted plus systematic biopsy will be performed.
Prostate biopsy In patients with suspicious lesion found on MRI (identified as PI-RADS score 3-5 lesions on bp-MRI or mp-MRI), biopsies will be done via trans-perineal approach under general anesthesia with 3 cores of targeted biopsy from each lesion, alone with 3 cores of systemic biopsy from right and left lobes respectively.
In those without identified suspicious lesions on MRI, a standard 12-core systematic biopsy will be performed via trans-rectal approach under local anesthesia.
All biopsies will be performed by Urologists experienced in both targeted and systemic prostate biopsy. Targeted biopsies will be done by software-assisted MRI-USG fusion registration. Peri-biopsy antibiotics are given according to our clinical guidelines.
Post-biopsy management Patients will be discharged after prostate biopsy when they can pass urine without significant gross hematuria, and clinically stable. They will be followed up in the clinic within 10 days after a biopsy to review pathology results and complications. All biopsies will be assessed by experienced Urogenital pathologists and reported according to the International Society of Urological Pathology (ISUP) consensus. The study period ends after the first clinic follow-up.
In our medical research, the investigators prioritize protecting participant privacy and confidentiality. The investigators use unique research codes to anonymize personal details like names and IDs. The principal investigator keeps consultation results and diagnoses confidential, even in published research. Participants consent to have their records reviewed by authorized parties for legal and ethical compliance, with a promise of maintaining their anonymity. For safety, the investigators may inform participants' other doctors about their trial involvement to manage treatment interactions. Overall, these steps ensure participant privacy and safety throughout the research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prostate cancer | Experimental | Diagnostic Test: bp-MRI prostate, Diagnostic Test: mp-MRI prostatePatients who are suspicious of prostate cancers with abnormal digital examination, or abnormal ultrasound and having a pre-MRI and were scheduled to receive prostate biopsy will be enrolled in this study. Patients will be randomized in a 1:1 manner to bp-MRI and mp-MRI. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men ≥50 years of age
- Clinical suspicion of prostate cancer and indicated for prostate biopsy
- Serum Prostate-specific antigen (PSA) between 4~20 ng/mL
- Eligible for MRI study
- Digital rectal examination ≤ cT2 (organ-confined cancer)
Key exclusion criteria (10 listed)
- Prior prostate biopsy in the 6 months before screening visit
- Prior diagnosis of prostate cancer
- Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
- Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
- Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
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 |
|---|---|---|
| bp-MRI prostateBiparametric MRI is considered less comprehensive compared to multiparametric MRI (mp-MRI), which includes additional parameters like dynamic contrast-enhanced MRI (DCE-MRI). However, bp-MRI offers a simpler, faster, and often less expensive alternative that still provides critical diagnostic information, particularly in the detection of clinically significant prostate cancer. It's commonly used where less comprehensive assessment is sufficient or in situations where contrast use is contraindicated. | Diagnostic test | prostate cancer |
| mp-MRI prostateMultiparametric MRI is highly valued for its ability to improve the detection and characterization of clinically significant prostate cancer, aid in biopsy guidance, and help in treatment planning and monitoring. Its comprehensive approach provides crucial insights that are not as readily available through simpler imaging modalities like biparametric MRI (bp-MRI). | Diagnostic test | prostate cancer |
Primary outcome
Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples
Time frame: 2-3 weeks
The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core.
1 secondary outcome
Prostate Cancer Diagnosis Rates and Specifics in Biopsy Methods
Time frame: 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bp-MRI prostate and mp-MRI prostate in people with Randomized Controlled Trial and Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 10 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 10 May 2024. 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 Taiwan. 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 See-Tong Pang, MD. PhD. (0975365572, jacobpang@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples (time frame: 2-3 weeks). 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 May 2024.