Exploring the Correlation Between MRI Image Characteristics and Diagnosis, Pathology and Prognosis in Patients With Prostate Lesions

NCT06946771 | Recruiting

• 1 other identifier: TJ-IRB202502097
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Carcinoma; MRI; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

  The time from the patient's enrollment and MRI examination to the pathological results is within one month.

Secondary Outcomes (2)

• Gleason grading of prostate cancer

  The time from the patient's enrollment and MRI examination to the pathological results is within one month.

• Prostate cancer prognosis

  Biochemical recurrence results at one, two, and three years from patient enrollment to treatment

Interventions

Advanced MRI parameters for the diagnosis of prostate cancer DIAGNOSTIC_TEST

This 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhen Li: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhen Li

CONTACT

02783663543; zhenli@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 27, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CN (1)