Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis (NCT06575361) | Clinical Trial Compass
CompletedNot Applicable
Comprehensive Evaluation of MRI-AI in Prostate Cancer Diagnosis
China365 participantsStarted 2024-01-01
Plain-language summary
The goal of this real-world prospective diagnostic study is to comprehensively evaluate the value of MRI artificial intelligence (MRI-AI) in assisting the diagnosis of prostate cancer (PCa). The main questions it aims to answer are:
Does MRI-AI promote the accurate diagnosis and treatment of prostate cancer? What's the capability of prostate MRI-AI in calculating the prostate volumn? What's the value of prostate MRI-AI assistant diagnosis system in detecting the suspicious lesions on MRI and guiding prostate targeted biopsy? What's the value of prostate MRI-AI assistant diagnosis system in predicting the pathological results of prostate targeted biopsy? Researchers will compare the cancer detection rates of suspicious lesions detected by MRI-AI and senior radiologists.
Participants will:
Receive combination of systematic biopsy and targeted biopsy.
Who can participate
Age range
45 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The age of the patient is between 45 and 85.
* Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control.
* 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 had no history of prior prostate surgery or biopsy.
* The PSA of patients should be ≤20 ng/mL.
* The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month.
* Patients with complete clinical information.
Exclusion Criteria:
* The clinicopathological information and MRI data was unqualified or incomplete.
* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
* Patients received prior prostate biopsy.
* Patients had contraindications to MRI or prostate biopsy.
* Patients were not in accordance with the indication of prostate biopsy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The clinically significant prostate cancer (csPCa) detection rate for suspicious lesions found by MRI-AI and urogenital radiologists