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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age20-90
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • observational study

    Other intervention

    The researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions.

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: the categorie is GG1 according to the ISUP grading standard1 intervention
Group B: the categorie is GG2 according to the ISUP grading standard1 intervention
Group C: the categorie is GG3 according to the ISUP grading standard1 intervention
Group D: the categorie is GG4 according to the ISUP grading standard1 intervention
Group E: the categorie is GG5 according to the ISUP grading standard1 intervention

Trial outcomes

Primary outcomes

1

Microstructure parameters related to the OGSE sequence

Time frame
Within one week after the MRI scan
2

CEST sequence-related numerical values

Time frame
Within one week after the MRI scan
3

MAGIC sequence-related numerical values

Time frame
Within one week after the MRI scan
4

IVIM sequence-related numerical values

Time frame
Within one week after the MRI scan

Secondary outcomes

1

Regular sequence-related numerical values

Time frame
Within one week after the MRI scan

Other outcomes

Sponsors and contacts

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