NCT07647445Not yet recruiting
Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management
A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men. Normally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists. The PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report. If there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- University College, London
- Diseases
- Prostate cancer
- NCT number
- NCT07647445
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 1 Oct 2026 to the primary completion date, 31 Jan 2029
- No sites listed in no 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
- Prior prostate biopsy
- Prior prostate MRI on a previous encounter\*
- Prior treatment for prostate cancer
- Unfit to undergo any procedures listed in protocol
- An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.
Other
- Contraindication to MRI (e.g. claustrophobia, pacemaker)
- Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic/spinal metalwork)
- Contraindication to prostate biopsy
Who the study is looking for
- Men at least 18 years of age referred with clinical suspicion of prostate cancer
- Serum PSA ≤ 20 ng/mL
- Fit to undergo all procedures listed in the protocol
- Able to provide written informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.