Prostate Cancer5TbpMRINCT06612047
Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are: Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 31 Dec 2026
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI and with indications of prostate biopsy. An informed consent conversation was conducted with the patient. After the patient fully understood the content of the study and signed the informed consent form, the researcher guided and arranged the 5.0TbpMRI examination throughout the process. All patients should complete the prostate biopsy according to the routine diagnosis and treatment process. The pathological diagnosis results of the prostate biopsy are the diagnostic gold standard of this study. The accuracy of 3.0TbpMRI and 5.0TbpMRI in preoperative prostate cancer tumor staging based on the final pathological results of radical prostatectomy.
Who may be able to join
- The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) );
- The primary prostate cancer has no other cancer history;
- The 3.0TbpMRI examination was completed, and the images were clear and accessible;
- The 5.0TbpMRI examination was further completed, and the images were clear and accessible;
- The patient fully understands the relevant content of the study and voluntarily signs the informed consent.
Who cannot join
- The patient has contraindications to MRI examination, such as metal plates and heart stents in the body;
- The patient does not have an indication for prostate biopsy or refuses biopsy;
- The patient has contraindications to prostate biopsy;
- 3.0T MRI considers that the patient has multiple lymph node or bone metastases;
- The patient has undergone other prostatic surgery in the past;
- The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form.
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
Department of Urology, The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Changming Wang, M.D., +8615840256553, anhui930602wcm@126.com
About this study
Official title: Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study
The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are:
- Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer.
- Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer.
The data of participants was collected prospectively.
Read the detailed description
The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Prostate biopsy
- Keywords
- Prostate cancer, prostate biospy, Biparametric Magnetic Resonance, Prostate Imaging-Reporting and Data System, Diagnosis
- 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.
Prostate biopsyProcedure or surgery
All patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI | All enrolled patients need to undergo 5.0TbpMRI and 3.0TbpMRI (within one month). The magnetic resonance imaging sequences mainly include T1WI, multi-plane T2WI and multi-b-value DWI images. Receives: Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1.
Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.
Measured: through study completion, an average of 1 month
Secondary outcomes (2)
Evaluation of the reliability (repeatability) of the diagnostic test.
The inter-reader agreement was evaluated using Cohen's kappa analysis (Cohen's kappa coefficeint, P-value and 95%CI)
Measured: through study completion, an average of 1 month
Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer
Accuracy of prostate capsule invasion, seminal vesicle invasion and pelvic lymph node metastasis.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start8 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (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 Anhui Provincial 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, XiaoJun, Anhui Provincial Hospital
- Investigators
- Jun Xiao, M.D., Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612047
- Sponsor's protocol ID
- 2024-ky399
- Acronym
- 5TbpMRI
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2024
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study
- ClinicalTrials.gov ID
- NCT06612047
- Acronym / sponsor ID
- 5TbpMRI / 2024-ky399
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, prostate biospy, Biparametric Magnetic Resonance, Prostate Imaging-Reporting and Data System, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 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.
The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are:
- Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer.
- Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer.
The data of participants was collected prospectively.
Detailed description
The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI | – | Procedure: Prostate biopsyAll enrolled patients need to undergo 5.0TbpMRI and 3.0TbpMRI (within one month). The magnetic resonance imaging sequences mainly include T1WI, multi-plane T2WI and multi-b-value DWI images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI and with indications of prostate biopsy. An informed consent conversation was conducted with the patient. After the patient fully understood the content of the study and signed the informed consent form, the researcher guided and arranged the 5.0TbpMRI examination throughout the process. All patients should complete the prostate biopsy according to the routine diagnosis and treatment process. The pathological diagnosis results of the prostate biopsy are the diagnostic gold standard of this study. The accuracy of 3.0TbpMRI and 5.0TbpMRI in preoperative prostate cancer tumor staging based on the final pathological results of radical prostatectomy.
Key inclusion criteria (5 listed)
- The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) );
- The primary prostate cancer has no other cancer history;
- The 3.0TbpMRI examination was completed, and the images were clear and accessible;
- The 5.0TbpMRI examination was further completed, and the images were clear and accessible;
- The patient fully understands the relevant content of the study and voluntarily signs the informed consent.
Key exclusion criteria (6 listed)
- The patient has contraindications to MRI examination, such as metal plates and heart stents in the body;
- The patient does not have an indication for prostate biopsy or refuses biopsy;
- The patient has contraindications to prostate biopsy;
- 3.0T MRI considers that the patient has multiple lymph node or bone metastases;
- The patient has undergone other prostatic surgery in the past;
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 biopsyAll patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results. | Procedure or surgery | Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI |
Primary outcome
Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
Time frame: through study completion, an average of 1 month
Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.
2 secondary outcomes
Evaluation of the reliability (repeatability) of the diagnostic test.
Time frame: through study completion, an average of 1 month
Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer
Time frame: through study completion, an average of 2 months
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 11 Feb 2025.
- 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.
Jun Xiao, M.D. principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Anhui Provincial 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 5 inclusion and 6 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 11 Feb 2025. 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 Changming Wang, M.D. (15840256553, wcmurologist@mail.ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. (time frame: through study completion, an average of 1 month). 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 11 Feb 2025.