the Application of Artificial Intelligence in the Diagnosis of Prostate CancerNCT05513638
Artificial Intelligence-Based Computer-Aided Diagnosis of Prostate Cancer
An observational study of the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men only
- Conditions the study is for
- the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer
- What is being tested?
- the clinical use of artificial intelligence in the diagnosis of prostate cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 22 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 60 years of age who are clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination during the study enrollment period, will be eligible for inclusion. Patients will be excluded from screening if they are: (1) <60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.
Who may be able to join
- Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination
Who cannot join
- (1) <60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yu-Dong Zhang
Nanjing, 210029
Yu-Dong Zhang, MD;PHD, 15805151704, njmu_zyd@163.com
About this study
Official title: Safety and Accuracy of Artificial Intelligence-aided Precision MRI Assessment for the Optimization of Prostate Biopsy in Men With Suspicion of Prostate Cancer: a Multicenter Randomized Controlled Trial.
One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.
- Being tested
- the clinical use of artificial intelligence in the diagnosis of prostate cancer
- Keywords
- artificial intelligence, prostate cancer, magnetic resonance imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the clinical use of artificial intelligence in the diagnosis of prostate cancerDiagnostic test
Each study site will enroll consecutive eligible patients and randomize them to either (a) a group with human-based interpretation or (b) a group with human-artificial intelligence interactive interpretation, both of which are utilized as standards of care.
| Study group | Role | What they receive |
|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Not described Receives: Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer | |
| The First Affiliated Hospital of Soochow University | Not described Receives: Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer
Biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer will serve as our primary outcome. Details of follow up and disease progression for a period of two years following mp-MRI will also be collected. For patients with no suspicious lesions on mp-MRI or biopsy-negative, follow-up prostatic specific antigen for a period of two years will also be collected.
Measured: Aug,22nd,2022-Aug,22nd,2024
Secondary outcomes (3)
surgery confirmed T and N staging of prostate cancer
surgery confirmed T and N staging of prostate cancer
Measured: Aug,22nd,2022-Aug,22nd,2024
positive rate of prostate biopsy
positive rate of prostate biopsy in each arm
Measured: Aug,22nd,2022-Aug,22nd,2024
the total reviewing time
The total reviewing time of radiologists will be measured in this aim. The reviewing time will be defined as the time from initiation of interpretating prostate mp-MRI to the time the radiologists finish reviewing and assigning a PI-RADS score.
Measured: Aug,22nd,2022-Aug,22nd,2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start22 Aug 2022
- Primary completion22 Aug 2024 (estimated)
- Study completion22 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Application of Artificial Intelligence in the Diagnosis of Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513638
- Sponsor's protocol ID
- 2019-SR-396
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2022
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Accuracy of Artificial Intelligence-aided Precision MRI Assessment for the Optimization of Prostate Biopsy in Men With Suspicion of Prostate Cancer: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05513638
- Acronym / sponsor ID
- 2019-SR-396
- Keywords
- artificial intelligence, prostate cancer, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 22 Aug 2024 (estimated)
- Study completion
- 22 Aug 2026 (estimated)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | – | Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer |
| The First Affiliated Hospital of Soochow University | – | Diagnostic Test: the clinical use of artificial intelligence in the diagnosis of prostate cancer |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 60 years of age who are clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination during the study enrollment period, will be eligible for inclusion. Patients will be excluded from screening if they are: (1) <60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.
Key inclusion criteria (1 listed)
- Clinical suspicious of prostate cancer, presenting with an elevated prostatic specific antigen and/or abnormal digital rectal examination
Key exclusion criteria (1 listed)
- (1) <60 years of age; (2) a previous surgery, radiotherapy or drug therapy for prostate cancer (interventions for benign prostatic hyperplasia or bladder outflow obstruction were deemed acceptable); (3) incomplete mp-MRI examination or artifacts of the images.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the clinical use of artificial intelligence in the diagnosis of prostate cancerEach study site will enroll consecutive eligible patients and randomize them to either (a) a group with human-based interpretation or (b) a group with human-artificial intelligence interactive interpretation, both of which are utilized as standards of care. | Diagnostic test | The First Affiliated Hospital of Nanjing Medical University, The First Affiliated Hospital of Soochow University |
Primary outcome
biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer
Time frame: Aug,22nd,2022-Aug,22nd,2024
Biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer will serve as our primary outcome. Details of follow up and disease progression for a period of two years following mp-MRI will also be collected. For patients with no suspicious lesions on mp-MRI or biopsy-negative, follow-up prostatic specific antigen for a period of two years will also be collected.
3 secondary outcomes
surgery confirmed T and N staging of prostate cancer
Time frame: Aug,22nd,2022-Aug,22nd,2024
positive rate of prostate biopsy
Time frame: Aug,22nd,2022-Aug,22nd,2024
the total reviewing time
Time frame: Aug,22nd,2022-Aug,22nd,2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biopsy or surgery confirmed newly-diagnosed prostate cancer and clinically significant prostate cancer (time frame: Aug,22nd,2022-Aug,22nd,2024). 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 21 Aug 2023.