NCT06946771

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

Recruiting now Last updated 27 April 2025

What this trial tests

trial testing Advanced MRI parameters for the diagnosis of prostate cancer in Prostate Carcinoma in 500 participants. Currently enrolling.

Timeline

25 February 2025

Primary endpoint
1 December 2027

31 December 2028

Quick facts

Lead sponsor	Zhen Li
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	25 February 2025
Primary completion	1 December 2027
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• Advanced MRI parameters for the diagnosis of prostate cancer

Conditions studied

• Prostate Carcinoma — all drugs for Prostate Carcinoma →
• MRI — all drugs for MRI →
• Diagnosis — all drugs for Diagnosis →

Sponsor

Zhen Li — full company profile →

Who can join

18 and older, male only, with Prostate Carcinoma or MRI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.