Prostate CancerNCT06507462
A Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 3 sites in China.
Trial summary
The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are: Construct a diagnostic model of patients with PI-RADS of score. Internal and external validation of the model. Decision curve analysis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- prostate biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 460 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to 31 Oct 2024
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This is a multicenter retrospective study. All enrolled patients were clinically suspected of prostate cancer (abnormal serum PSA level or DRE), had an indication for prostate biopsy and eventually underwent prostate biopsy. Before biospy, patients also need to complete mpMRI examination, the examination sequence includes at least multi-plane T2WI and multi-b value DWI, and the final patient PI-RADS score needs to be 3.
Who may be able to join
- Patients with clinically suspected prostate cancer (abnormal PSA level or DRE);
- All patients have undergone mpMRI and have complete imaging data;
- The PI-RADS score of patients was 3;
- Prostate biopsy was performed and has clear pathological results.
Who cannot join
- The patient's serum tPSA is <4ng/ml or >100ng/ml;
- Repeated prostate biopsy;
- The patient's clinical, imaging, or pathological data are incomplete.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of Urology, The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Department of Urology, The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Department of Urology, The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
About this study
Official title: Construction and Validation of a Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3: a Multicenter, Retrospective Study
The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are:
- Construct a diagnostic model of patients with PI-RADS of score.
- Internal and external validation of the model.
- Decision curve analysis. The data of participants was collected retrospectively.
Read the detailed description
For patients with a PI-RADS score of 3, the diagnosis of prostate cancer is still use prostate biopsy, but the detection rates of prostate cancer and clinically significant prostate cancer are approximately 30% and 15%. It can be seen that most patients with PI-RADS 3 undergo unnecessary prostate biopsy and bear the risk of complications such as urinary tract infection. This makes most patients with PI-RADS 3 choose to refuse invasive prostate biopsy. Although researchers are committed to exploring biomarkers with high sensitivity and specificity, the application of biomarkers alone often cannot achieve the expected results. At present, the guidelines have recommended the use of diagnostic prediction models to assess patients' prostate cancer risk. Doctors and patients use diagnostic models to assess the risk of prostate cancer before prostate biopsy. For patients with a low probability of cancer, biopsy can be temporarily avoided, which to a certain extent reduces the phenomenon of prostate cancer overdiagnosis. This study plans to work with multiple medical centers to conduct statistical analysis based on existing prostate cancer screening markers combined with patients' clinical data such as prostate volume, prostate-specific antigen density, apparent diffusion coefficient, PI-RADS score and postoperative Gleason score, and then construct a prostate cancer diagnostic model to improve the diagnostic accuracy of prostate cancer for patients with PI-RADS score of 3. This will be of great significance for improving the early diagnosis of patients with PI-RADS 3 and reducing unnecessary prostate puncture biopsies.
- Conditions
- Prostate Cancer
- Being tested
- prostate biopsy
- Keywords
- Prostate cancer, Predictive model, Diagnosis, Prostate Imaging-Reporting and Data System
- 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.
prostate biopsyProcedure or surgery
All patients were required to underwent transperineal prostate biopsy and have corresponding pathological diagnosis results.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3 | Patients with clinical suspicion of prostate cancer (see inclusion criteria) and have PI-RADS score (results of mpMRI) of 3. Receives: Procedure: prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer
The clinically significant prostate cancer was defined as Gleason score ≥ 3+4
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves.
Evaluate the discrimination and calibration of the model constructed by logistic regression analyses
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jan 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, XiaoJun, Anhui Provincial Hospital
- Investigators
- Jun Xiao, Pro., Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507462
- Sponsor's protocol ID
- 2024-ky312
- Status last verified
- Feb 2025
- First submitted
- 4 Jul 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Diagnostic Prediction Model for Prostate Cancer in Patients With PI-RADS Score 3: a Multicenter, Retrospective Study
- ClinicalTrials.gov ID
- NCT06507462
- Acronym / sponsor ID
- 2024-ky312
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Predictive model, Diagnosis, Prostate Imaging-Reporting and Data System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 18 Jul 2024 (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.
The goal of this observational study is to construct a predictive model for improving the diagnostic accuracy in patients with PI-RADS score of 3. The main aims of this study are:
- Construct a diagnostic model of patients with PI-RADS of score.
- Internal and external validation of the model.
- Decision curve analysis. The data of participants was collected retrospectively.
Detailed description
For patients with a PI-RADS score of 3, the diagnosis of prostate cancer is still use prostate biopsy, but the detection rates of prostate cancer and clinically significant prostate cancer are approximately 30% and 15%. It can be seen that most patients with PI-RADS 3 undergo unnecessary prostate biopsy and bear the risk of complications such as urinary tract infection. This makes most patients with PI-RADS 3 choose to refuse invasive prostate biopsy. Although researchers are committed to exploring biomarkers with high sensitivity and specificity, the application of biomarkers alone often cannot achieve the expected results. At present, the guidelines have recommended the use of diagnostic prediction models to assess patients' prostate cancer risk. Doctors and patients use diagnostic models to assess the risk of prostate cancer before prostate biopsy. For patients with a low probability of cancer, biopsy can be temporarily avoided, which to a certain extent reduces the phenomenon of prostate cancer overdiagnosis. This study plans to work with multiple medical centers to conduct statistical analysis based on existing prostate cancer screening markers combined with patients' clinical data such as prostate volume, prostate-specific antigen density, apparent diffusion coefficient, PI-RADS score and postoperative Gleason score, and then construct a prostate cancer diagnostic model to improve the diagnostic accuracy of prostate cancer for patients with PI-RADS score of 3. This will be of great significance for improving the early diagnosis of patients with PI-RADS 3 and reducing unnecessary prostate puncture biopsies.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3 | – | Procedure: prostate biopsyPatients with clinical suspicion of prostate cancer (see inclusion criteria) and have PI-RADS score (results of mpMRI) of 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter retrospective study. All enrolled patients were clinically suspected of prostate cancer (abnormal serum PSA level or DRE), had an indication for prostate biopsy and eventually underwent prostate biopsy. Before biospy, patients also need to complete mpMRI examination, the examination sequence includes at least multi-plane T2WI and multi-b value DWI, and the final patient PI-RADS score needs to be 3.
Key inclusion criteria (4 listed)
- Patients with clinically suspected prostate cancer (abnormal PSA level or DRE);
- All patients have undergone mpMRI and have complete imaging data;
- The PI-RADS score of patients was 3;
- Prostate biopsy was performed and has clear pathological results.
Key exclusion criteria (3 listed)
- The patient's serum tPSA is <4ng/ml or >100ng/ml;
- Repeated prostate biopsy;
- The patient's clinical, imaging, or pathological data are incomplete.
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 |
|---|---|---|
| prostate biopsyAll patients were required to underwent transperineal prostate biopsy and have corresponding pathological diagnosis results. | Procedure or surgery | Patients with clinical suspicion of prostate cancer and have PI-RADS score of 3 |
Primary outcome
Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer
Time frame: through study completion, an average of 3 months
The clinically significant prostate cancer was defined as Gleason score ≥ 3+4
1 secondary outcome
Validation by calculating the C-statistics, drawing ROC curves (AUC values) and calibration curves.
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jun Xiao, Pro. principal investigator
The First Affiliated Hospital of University of Science and Technology of China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 3 sites 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate logistic regression analyses and calculate the odds ratios (95% confidence interval ) of the clinical variables for clinically significant prostate cancer (time frame: through study completion, an average of 3 months). 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 11 Feb 2025.