NCT06362291Completed
Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial
Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are: Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB. Participants will: Receive AI-cTB or routine cTB.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 380 (actual)
- First submitted
- 9 Apr 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Mar 2024
- Lead sponsor
- Peking University First Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06362291
What you commit to
- Study type: Interventional
- Participants enrolled: 380
- From 1 Aug 2023 to the primary completion date, 31 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
- Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.
Other
- The mpMRI data was unqualified or incomplete.
- The mpMRI of Peking University First Hospital did not find suspicious prostate lesions.
- The patient could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study.
- Patients with incomplete clinical information.
Who the study is looking for
- The age of the patient is between 45 and 85.
- Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of Peking University First Hospital, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
- Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
- Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA \> 10 ng/ml; re-examination of PSA 4\~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4\~10ng/ml and with close follow-up, PSA for 2 consecutive years \> 10ng/ml or PSA volume \> 0.75/ml/ years). The time interval between the two prostate biopsies should be longer than three months.
- The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
- Patients with complete clinical information.
Age in the registry: 45 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.