Prostate CancerNCT07552285
The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center
An observational study of Prostate Cancer and Prostate Cancer (Diagnosis), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is: Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate… Read more about this study
- Who is it for?
- Ages 20 to 90 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Diagnosis)
- What is being tested?
- observational study
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Jun 2027
- How long will I take part?
- 4 Months
- 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 20 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical suspicion of prostate cancer, those who have a serum tPSA level greater than 4.0 ng/ml during outpatient examination, and patients with clinical manifestations of frequent urination, urgent urination and incomplete urination.
Who may be able to join
- Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;
- Patients with no prior history of other tumors;
- Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.
Who cannot join
- The patient has a history of malignant tumors and has received corresponding treatment;
- Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;
- Patients who have previously undergone radical prostatectomy for prostate cancer.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Gang Chen, +86 0512 67972861, E-mail:sdfyec@163.com
About this study
The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is:
Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.
- Conditions
- Prostate Cancer, Prostate Cancer (Diagnosis)
- Being tested
- observational study
- 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.
observational studyOther
The researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions.
| Study group | Role | What they receive |
|---|---|---|
| the categorie is GG1 according to the ISUP grading standard | Not described Receives: Other: observational study | |
| the categorie is GG2 according to the ISUP grading standard | Not described Receives: Other: observational study | |
| the categorie is GG3 according to the ISUP grading standard | Not described Receives: Other: observational study | |
| the categorie is GG4 according to the ISUP grading standard | Not described Receives: Other: observational study | |
| the categorie is GG5 according to the ISUP grading standard | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microstructure parameters related to the OGSE sequence
Measured: Within one week after the MRI scan
CEST sequence-related numerical values
Measured: Within one week after the MRI scan
MAGIC sequence-related numerical values
Measured: Within one week after the MRI scan
IVIM sequence-related numerical values
Measured: Within one week after the MRI scan
Secondary outcomes (1)
Regular sequence-related numerical values
Measured: Within one week after the MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (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 The First Affiliated Hospital of Soochow UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552285
- Sponsor's protocol ID
- 2025465
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center
- ClinicalTrials.gov ID
- NCT07552285
- Acronym / sponsor ID
- 2025465
- Conditions
- Prostate Cancer, Prostate Cancer (Diagnosis)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Apr 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.
The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is:
Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| the categorie is GG1 according to the ISUP grading standard | – | Other: observational study |
| the categorie is GG2 according to the ISUP grading standard | – | Other: observational study |
| the categorie is GG3 according to the ISUP grading standard | – | Other: observational study |
| the categorie is GG4 according to the ISUP grading standard | – | Other: observational study |
| the categorie is GG5 according to the ISUP grading standard | – | Other: observational study |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical suspicion of prostate cancer, those who have a serum tPSA level greater than 4.0 ng/ml during outpatient examination, and patients with clinical manifestations of frequent urination, urgent urination and incomplete urination.
Key inclusion criteria (3 listed)
- Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;
- Patients with no prior history of other tumors;
- Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.
Key exclusion criteria (3 listed)
- The patient has a history of malignant tumors and has received corresponding treatment;
- Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;
- Patients who have previously undergone radical prostatectomy for prostate cancer.
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 |
|---|---|---|
| observational studyThe researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions. | Other | the categorie is GG1 according to the ISUP grading standard, the categorie is GG2 according to the ISUP grading standard, the categorie is GG3 according to the ISUP grading standard, the categorie is GG4 according to the ISUP grading standard, the categorie is GG5 according to the ISUP grading standard |
Primary outcome
Microstructure parameters related to the OGSE sequence
Time frame: Within one week after the MRI scan
CEST sequence-related numerical values
Time frame: Within one week after the MRI scan
MAGIC sequence-related numerical values
Time frame: Within one week after the MRI scan
IVIM sequence-related numerical values
Time frame: Within one week after the MRI scan
1 secondary outcome
Regular sequence-related numerical values
Time frame: Within one week after the MRI scan
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 27 Apr 2026.
- 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?
An observational study of Prostate Cancer and Prostate Cancer (Diagnosis), run by The First Affiliated Hospital of Soochow University 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 3 inclusion and 3 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 27 Apr 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 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 Qian Zhang (+86 15137562688, zhangqian0194@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microstructure parameters related to the OGSE sequence (time frame: Within one week after the MRI scan). The study lists 4 primary outcomes in all. 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 27 Apr 2026.