About this trial
Globally, prostate cancer is the second most common malignant tumor and the fifth leading cause of cancer-related death in men. In China, there will be more than 125,000 new cases of prostate cancer in 2022, ranking sixth in the incidence of male cancers, causing about 56,000 deaths, ranking tenth among male malignancies. The gold standard for the diagnosis of prostate cancer is prostate biopsy. In the past, whether to initiate a biopsy procedure depended on the screening results of abnormal prostate cancer, namely, elevated serum PSA levels (\>4.0 ng/mL) and abnormal digital rectal examination (DRE), but the low accuracy led to a large number of negative biopsy results, overdiagnosis and overtreatment of indolent tumors, causing many patients to undergo unnecessary biopsies, resulting in a large social burden.
Magnetic resonance imaging (MRI) has been widely used in clinical practice due to its advantages of high soft tissue resolution, multi-plane, multi-sequence, multi-parameter imaging and no ionizing radiation. Studies have shown that multiparametric MRI (mpMRI), including T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), and dynamic contrast enhancement (DCE), can help select patients for initial biopsy and improve the detection rate of biopsy.
MRI plays a vital role in the clinical diagnosis and treatment of prostate lesions. However, prostate MRI examinations often show "same disease, different images" and "different diseases, same images". Benign prostate lesions can simulate the characteristics of malignant lesions to interfere with the image and the judgment of clinicians, resulting in misdiagnosis and mistreatment. For example, inflammation in the peripheral zone of the prostate, like tumors, appears as low signal on T2WI, and hyperplastic nodules in the transition zone may also appear as restricted diffusion on DWI like tumors. Therefore, the complementary addition of different parameter sequences and the comprehensive judgment of qualitative and quantitative characteristics are very important for accurate diagnosis.
With the development of magnetic resonance technology, new imaging sequences continue to emerge, which can not only show the anatomical decomposition of the prostate more clearly, but also reflect the characteristics of the lesions from the pathological and physiological perspectives such as function, metabolism, and blood perfusion, and can better characterize prostate lesions.
The purpose of this study is to study the routine and functional MR imaging data of patients with prostate lesions in our institution, use pathology as the gold standard, and use image processing software to conduct qualitative and quantitative analysis of body composition, imaging characteristics, peritumoral tissue characteristics, and lymph node characteristics, so as to achieve benign and malignant differentiation, pathological feature prediction, and prognosis evaluation, in order to better perform accurate diagnosis, clinical decision-making, and prognosis evaluation in patients with prostate lesions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with abnormal prostate-specific antigen (PSA) elevated (>4.0 ng/ml) or abnormal digital rectal examination (DRE) or suspicious lesions found by prostate ultrasound, CT or MRI in the hospital
Age/Gender: Adult male
Patients who voluntarily participate in clinical trials and sign a written informed consent form for subjects
Disqualifiers
Patients with pacemakers, unknown materials, metal implants in the body, neurostimulators, and claustrophobia
Patients who underwent biopsy, local ablation, prostate surgery, or endocrine therapy, chemotherapy, radiotherapy and other anti-tumor treatments before examination
Trial population
The population of this study was adult male patients who were clinically suspected of prostate tumors and met the inclusion and exclusion criteria. They underwent prostate MRI examination at Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology and were scheduled to undergo prostate biopsy or radical resection and receive pathological examination.
Trial design
Cohort
Prospective
Treatments tested in this trial
Advanced MRI parameters for the diagnosis of prostate cancer
Diagnostic testThis study aims to use time-dependent DWI (td-DWI) to fit and calculate quantitative information such as cellularity, cell diameter, intracellular volume fraction and cell density; use the chemical exchange saturation transfer (CEST) sequence to saturate hydrogen protons (hydroxyl (-OH), amide (-NH) and amine (-NH2) groups) in specific metabolites in the body by applying frequency-selective saturation pulses to non-invasively reflect metabolic information in the human body for the diagnosis of prostate cancer and to evaluate its diagnostic accuracy compared with traditional multi-parameter magnetic resonance imaging.
Treatment groups
Trial outcomes
Primary outcomes
Clinically significant prostate cancer according to pathological diagnosis
From the time the patient receives a prostate MRI to the time the patient undergoes a biopsy or surgery and obtains pathology results
Secondary outcomes
Gleason grading of prostate cancer
From the time the patient receives a prostate MRI to the time the patient undergoes a biopsy or surgery and obtains pathology results
Prostate cancer prognosis
Follow-up results from patient enrollment to treatment, including biochemical recurrence results at one, two, three years.
Sponsors and contacts
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Zhen Li
Lead sponsor
Tongji Hospital
Sponsor institution