Prostate CancerNCT06737588
The Addictive Diagnostic Value of Apparent Diffusion Coefficients to bpMRI in the Diagnosis of Prostate Cancer
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 2 sites in China.
Trial summary
The goal of this study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 study is observational and does not require any intervention for patients, who only need to complete the routine diagnosis and treatment procedures. This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI containing ADC maps and with indications of prostate biopsy.
Who may be able to join
- The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
- Serum PSA test was completed in the patient with tPSA < 100 ng/ml;
- Primary prostate tumor lesion, no history of other tumors;
- Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
- Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.
Who cannot join
- The patient has contraindications for MRI;
- PI-RADS 1-2 of bpMRI;
- The patient had contraindications to prostate biopsy or explicitly refused biopsy;
- bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
- Previous prostate-related surgery;
- The patient refused to sign the informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Hefei, Anhui, 230001
Changming Wang, M.D., 15840256553, anhui930602wcm@126.com
Jun Xiao, M.D., 13956934087, anhuiurology@126.com
- Not yet recruiting
Department of Urology, The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
Dong Zhuo, M.D., 17838306531, whzhuo2008@sina.com
About this study
Official title: The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
The goal of this study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP grade ≥2) and any-grade prostate cancer (Gleasonscore≥3+3, ISUP grade ≥1).
Read the detailed description
The study is conducted with suspected prostate cancer. Patients with PI-RADS scores of 3-5 after completing prostate bpMRI chose to undergo prostate biopsy. Before patients undergo prostate biopsy, researchers will collecte information on age, BMI, tPSA, f/PSA, PV, PSAD, ADCmean, ADCmin, ADCmax, ADCnormal, maximum lesion diameter, location of major lesions, and so on. For prostate biopsy, systematic prostate biopsy ± bpMRI cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and Gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. In this study, the pathological result is regarded as the gold standard. ROC curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. Relevant conclusions are finally drawn by comparing the diagnostic capacity of different ADC values for prostate cancer. Meanwhile, binary logistic regression analysis will also conduct the Odds ratios (ORs) and 95% confidence intervals (CIs) will be recorded.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate biospy, Biparametric Magnetic Resonance, Apparent diffussion coefficient, Prostate Imaging-Reporting and Data System, Diagnosis
- Medical subject headings
- Prostatic Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5.
csPCa means Gleason score ≥ 3+4， ISUP grade ≥ 2. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
Measured: through study completion, an average of 1 month
Secondary outcomes (3)
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for any-grade prostate cancer (PCa) (Gleason score ≥ 3+3, ISUP grade ≥ 1) in patients with PI-RADS 3-5.
agPCa means Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
Measured: through study completion, an average of 1 month
Evaluate the diagnostic capacity of different PI-RADS scores combined with different ADC cut off values for csPCa
ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.
Measured: through study completion, an average of 1 month
Compare the diagnostic value of different ADC values for csPCa in patients with 3-5 points of PI-RADS.
ROC curves and AUC value (95%CI), Sensetivity, Specificity, Positive predictive value and negative predictive value.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, XiaoJun, Anhui Provincial Hospital
- Investigators
- Jun Xiao, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737588
- Sponsor's protocol ID
- 2024-ky-495 (bpMRI-ADC)
- Status last verified
- Feb 2025
- First submitted
- 12 Dec 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
- The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06737588
- Acronym / sponsor ID
- 2024-ky-495 (bpMRI-ADC)
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Prostate biospy, Biparametric Magnetic Resonance, Apparent diffussion coefficient, Prostate Imaging-Reporting and Data System, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Dec 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 study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP grade ≥2) and any-grade prostate cancer (Gleasonscore≥3+3, ISUP grade ≥1).
Detailed description
The study is conducted with suspected prostate cancer. Patients with PI-RADS scores of 3-5 after completing prostate bpMRI chose to undergo prostate biopsy. Before patients undergo prostate biopsy, researchers will collecte information on age, BMI, tPSA, f/PSA, PV, PSAD, ADCmean, ADCmin, ADCmax, ADCnormal, maximum lesion diameter, location of major lesions, and so on. For prostate biopsy, systematic prostate biopsy ± bpMRI cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and Gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. In this study, the pathological result is regarded as the gold standard. ROC curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. Relevant conclusions are finally drawn by comparing the diagnostic capacity of different ADC values for prostate cancer. Meanwhile, binary logistic regression analysis will also conduct the Odds ratios (ORs) and 95% confidence intervals (CIs) will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is observational and does not require any intervention for patients, who only need to complete the routine diagnosis and treatment procedures. This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI containing ADC maps and with indications of prostate biopsy.
Key inclusion criteria (5 listed)
- The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
- Serum PSA test was completed in the patient with tPSA < 100 ng/ml;
- Primary prostate tumor lesion, no history of other tumors;
- Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
- Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.
Key exclusion criteria (6 listed)
- The patient has contraindications for MRI;
- PI-RADS 1-2 of bpMRI;
- The patient had contraindications to prostate biopsy or explicitly refused biopsy;
- bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
- Previous prostate-related surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5.
Time frame: through study completion, an average of 1 month
csPCa means Gleason score ≥ 3+4， ISUP grade ≥ 2. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
3 secondary outcomes
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for any-grade prostate cancer (PCa) (Gleason score ≥ 3+3, ISUP grade ≥ 1) in patients with PI-RADS 3-5.
Time frame: through study completion, an average of 1 month
Evaluate the diagnostic capacity of different PI-RADS scores combined with different ADC cut off values for csPCa
Time frame: through study completion, an average of 1 month
Compare the diagnostic value of different ADC values for csPCa in patients with 3-5 points of PI-RADS.
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Jun Xiao principal investigator
The First Affiliated Hospital of University of Science and Technology of China
2 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 2 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 5 inclusion and 6 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: looking for participants now, 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 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changming Wang (15840256553, wcmurologist@mail.ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5. (time frame: through study completion, an average of 1 month). 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.