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Prostate CarcinomaNCT06946771

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

An observational study of Prostate Carcinoma and MRI, run by Zhen Li at 1 site in China.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Carcinoma, MRI, Diagnosis
What is being tested?
Advanced MRI parameters for the diagnosis of prostate cancer
How many people
500 participants
Where
1 siteChina
Study dates
25 Feb 2025to 31 Dec 2028
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

    Wuhan, Hubei

    Kangwen He, 17728103109, kangwen_he@163.com

    Recruiting

Other trials in China

About this study

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.

Read more

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.

Read the detailed 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 among male cancers and causing about 56,000 deaths, ranking tenth among male malignancies. Currently recognized risk factors for prostate cancer include increasing age, race (black), genetic factors, insulin-like growth factor (IGF), and family history of malignant tumors. 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). However, 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 . The National Comprehensive Cancer Network (NCCN), the American Urological Association (AUA), the European Association of Urology (EAU), and the Chinese Prostate Cancer Diagnosis and Treatment Guidelines all recommend that mpMRI be considered for men with biopsy indications (such as elevated PSA) to reduce the number of men undergoing biopsy and improve the detection rate of clinically significant prostate cancer. In addition to guiding prostate puncture biopsy strategies, the clinical application of mpMRI in prostate cancer also includes the following aspects. First, mpMRI can be combined with transrectal ultrasound (TRUS) (MR-TRUS fusion) for targeted prostate cancer puncture, thereby improving the detection rate of high-grade lesions. Secondly, mpMRI plays a role in the initial staging of intermediate-risk and high-risk patients by detecting extracapsular extension of the prostate, seminal vesicle infiltration, and lymph node involvement. In addition, mpMRI plays an important role in active surveillance of prostate cancer, post-treatment evaluation, and detection of local recurrence after radical prostatectomy.

It can be seen that 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 judgment of images and clinicians, thereby causing misdiagnosis and mistreatment. For example, inflammation in the peripheral zone of the prostate, like a tumor, appears as a low signal on T2WI, while hyperplastic nodules in the transition zone may also appear as diffusion restricted on DWI, like a tumor. 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 imaging 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 perspectives of function, metabolism, blood perfusion and other pathological and physiological aspects, and can better characterize prostate lesions. For example, time-dependent DWI (td-DWI), as an advanced DWI technology, can not only qualitatively describe the diffusion state of water molecules in tissues through complex pulse sequence design and scientific mathematical modeling calculations, but also provide quantitative information such as cell diameter, intracellular volume fraction and cell density, thereby non-invasively reflecting the microstructural changes of tissues. In addition, the chemical exchange saturation transfer (CEST) sequence saturates the hydrogen protons (hydroxyl (-OH), amide (-NH) and amine (-NH2) groups) in specific metabolites in the body by applying frequency-selective saturation pulses, and uses the chemical exchange phenomenon between saturated hydrogen protons and free water to achieve non-invasive reflection of metabolic information in the human body, which has great application potential. These functional MRI imaging sequences can provide rich information and are still in the clinical trial stage. Once they are proven to be valuable for the detection of prostate cancer, they are expected to improve the current shortcomings of mpMRI in the clinical evaluation of prostate cancer.

This is a prospective study. By studying the routine and functional MR imaging data of patients with prostate lesions in this institution, taking pathology as the gold standard, and using image processing software to conduct qualitative and quantitative analysis of body composition, imaging characteristics, tumor surrounding tissue characteristics and lymph node characteristics, the aim is 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 of patients with prostate lesions. The total sample size is expected to be 500 cases. The main research steps are:

  1. Collection of imaging data: patients with the above criteria are included, and informed consent is signed after communication with them. Recommend the attending physician to prescribe an MR examination, sort out the patient's imaging data information after the examination, and record the image ID, examination item type and other information
  2. Image data processing: Through the PACS system, use the image workstation to copy the DICOM format image data, use the image processing software to perform qualitative and quantitative analysis, and record the relevant parameter values
  3. Clinical data collection: query the included patient list through the Radiology Information System (RIS) of the Radiology Department of Tongji Hospital, collect clinical data, postoperative pathology and imaging examination item types, including age, height, weight, blood pressure, past medical history, etc., laboratory examination data including blood routine, blood biochemistry, PSA, etc., pathological data including Gleason score, TNM stage, immunohistochemical characteristics, etc., treatment conditions including surgery, radiotherapy, chemotherapy and other information, track follow-up cases, and achieve prognosis evaluation
  4. Classify factors such as pathological typing, pathological grading, immunohistochemical characteristics, and clinical prognosis through laboratory examination data and pathological data, aiming to find the correlation between imaging characteristics and the above clinical related characteristics, so as to achieve image prediction of pathology, clinical prognosis and other information, and thus better make clinical decision choices.

The data mainly include the data obtained from the processing and analysis of imaging data, pathological immunohistochemistry, and laboratory test results. After the data are sorted out, SPSS, R language and Python are used for data processing and analysis.

Being tested
Advanced MRI parameters for the diagnosis of prostate cancer
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.

  • Advanced MRI parameters for the diagnosis of prostate cancerDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)
  1. 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

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

  2. Prostate cancer prognosis

    Follow-up results from patient enrollment to treatment, including biochemical recurrence results at one, two, three years.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start25 Feb 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06946771
Sponsor's protocol ID
TJ-IRB202502097
Status last verified
Apr 2025
First submitted
8 Apr 2025
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Carcinoma and MRI, run by Zhen Li 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 2 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 2025. 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 Zhen Li (02783663543, zhenli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically significant prostate cancer according to pathological diagnosis (time frame: The time from the patient's enrollment and MRI examination to the pathological results is within one month.). 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 2025.

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