Treatment-naive Prostate CancerDEPICTNCT07531329
Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer
An observational study of Treatment-naive Prostate Cancer and Suspected Prostate Cancer, run by Xijing Hospital at 9 sites in China.
Trial summary
Brief Summary This prospective, multicenter study evaluates whether delayed PSMA PET imaging improves diagnostic efficacy for detecting clinically significant prostate cancer (Gleason score ≥7) compared with standard imaging in patients with suspected newly diagnosed prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Treatment-naive Prostate Cancer, Suspected Prostate Cancer, Molecular Imaging
- What is being tested?
- [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only Acquisition
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 9 sitesChina
- Study dates
- 5 Mar 2021to 5 Mar 2028
- 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: The study population consists of a consecutive series of patients with suspected prostate cancer based on elevated PSA levels (≥4.0 ng/mL) who are referred for initial diagnostic evaluation at participating centers. All enrolled patients undergo dual-phase [⁶⁸Ga]Ga-PSMA-11 PET/CT imaging (standard whole-body acquisition at approximately 60 minutes post-injection, followed by delayed pelvic PET acquisition at approximately 2-3 hours post-injection) prior to transrectal or transperineal prostate biopsy. Eligible patients must have no prior history of prostate cancer-related treatment and no other active malignancy within the past two years. This prospective cohort represents a typical diagnostic population in whom the incremental value of delayed PSMA PET imaging for prostate cancer detection is being investigated.
Who may be able to join
- Patients with suspected prostate cancer and a PSA level ≥4.0 ng/mL
- Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy
- Patients who are willing to undergo prostate biopsy
- Patients who provide written informed consent to participate in the study
Who cannot join
- Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan
- Patients with a history of other malignancies within the past two years
- Patients judged by the study investigator to be at risk for serious complications that could interfere with the normal conduct of the study
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Wei Zhang, MD., +86 18700919857, 1531769428@qq.com
Wei Zhang, MD.
- Recruiting
Weinan Central Hospita
Weinan, Shaanxi
Weihong Zhao, MD., +86 18700919857, 1531769428@qq.com
Weihong Zhao, MD.
- Recruiting
Xijing 986 Hospital
Xi'an, Shaanxi, 710032
Wuhe Zhang, +86 18700919857, 1531769428@qq.com
Wuhe Zhang, MD.
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jianhua Jiao, MD., +86 18700919857, 1531769428@qq.com
Weijun Qin, MD.
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi
Yi Sun, MD., +86 18700919857, 1531769428@qq.com
Yi Sun, MD.
- Recruiting
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Wei Zheng, MD., +86 18700919857, 1531769428@qq.com
Wei Zheng, MD.
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Guojun Chen, MD., +86 18700919857, 1531769428@qq.com
Guojun Chen, MD.
- Recruiting
Affiliated Hospital of Yan'an University
Yan’an, Shaanxi
Jixue Gao, MD., +86 18700919857, 1531769428@qq.com
Jixue Gao, MD.
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Zhiyong Lv, +86 18700919857, 1531769428@qq.com
Zhiyong Lv, MD.
About this study
Brief Summary This prospective, multicenter study evaluates whether delayed PSMA PET imaging improves diagnostic efficacy for detecting clinically significant prostate cancer (Gleason score ≥7) compared with standard imaging in patients with suspected newly diagnosed prostate cancer. Each patient serves as their own control, with diagnostic performance compared between standard (60-minute) and delayed (2-3 hour) acquisitions.
Background PSMA PET has transformed prostate cancer imaging, with emerging evidence suggesting delayed acquisition may further improve diagnostic accuracy by increasing tumor-to-background ratio. Recent studies demonstrate that delayed imaging significantly reduces equivocal findings and enhances detection of clinically significant prostate cancer.
Read more
Need While standard PSMA PET is well-validated, prospective multicenter data specifically evaluating the incremental diagnostic value of delayed imaging for clinically significant prostate cancer in treatment-naïve patients are lacking. This study addresses this gap by systematically comparing standard and delayed imaging in a large, well-defined cohort.
Primary Outcome The primary outcome is to compare the area under the curve (AUC) of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (csPCa), and to determine whether delayed imaging is superior to standard imaging.
Secondary Outcomes
- Optimal diagnostic thresholds for delayed imaging
- Determine the optimal threshold for delayed SUVmax using ROC analysis with the Youden index;
- Determine the optimal threshold for ΔSUVmax (delayed minus standard SUVmax);
- Validate the sensitivity, specificity, and AUC of these thresholds in an independent validation set.
- Biopsy avoidance potential In patients with PI RADS 4-5 lesions, calculate the negative predictive value (NPV) using a predefined high threshold to estimate the proportion who could safely avoid biopsy.
- Diagnostic performance in key subgroups Compare the AUC of delayed SUVmax versus standard SUVmax for csPCa detection in patients with PI RADS 2-3 and in those with PI RADS 4-5.
- Additional lesion detection Proportion of patients with additional csPCa lesions detected only on delayed imaging, and the proportion whose PI RADS category would be upgraded based on these findings.
- Clinical decision impact Proportion of patients in whom management recommendations would change after incorporating delayed imaging results, compared with standard imaging alone.
- Exploratory subgroup analyses Stratify by PSA level (<4, 4 10, >10 ng/mL) and PSA density (<0.10, 0.10-0.20, >0.20 ng/mL/cc) to identify subgroups that derive the greatest benefit from delayed imaging; additionally, explore combined subgroups such as PI RADS 3 with PSA 4-10 or PSAD 0.10-0.20.
Inclusion Criteria
- Suspected prostate cancer based on elevated PSA (≥4.0 ng/mL) or clinical symptoms
- Undergo PSMA PET (standard + delayed) prior to prostate biopsy
- Willing to undergo prostate biopsy
- Provide written informed consent Exclusion Criteria
- Prior prostate cancer treatment before PSMA PET imaging 2. Other malignancy within past two years 3. Investigator-judged risk of serious complications interfering with study conduct
Read the detailed description
Study Design and Objective This is a prospective, multicenter diagnostic accuracy study designed to evaluate whether delayed PSMA PET imaging improves diagnostic efficacy for clinically significant prostate cancer (csPCa) compared with standard imaging in patients with suspected newly diagnosed, treatment-naïve prostate cancer. Each patient serves as their own control.
Imaging Protocol
All enrolled patients undergo dual-time-point PSMA PET/CT before biopsy:
- Standard acquisition: whole-body imaging at approximately 60 minutes post-injection.
- Delayed acquisition: pelvic-focused imaging at 2-3 hours post-injection.
Reference Standard All patients undergo prostate biopsy using 12-core systematic biopsy plus targeted biopsy when indicated. Histopathology serves as the reference standard. csPCa is defined as ISUP grade group ≥2.
Primary Outcome To compare the area under the receiver operating characteristic curve (AUC) of delayed SUVmax versus standard SUVmax for detecting csPCa, and to determine whether delayed imaging is superior to standard imaging.
Secondary Outcomes
- Optimal diagnostic thresholds for delayed SUVmax and ΔSUVmax, with internal validation;
- Negative predictive value (NPV) and biopsy avoidance potential (especially in PI-RADS 4-5 patients);
- Diagnostic performance in key subgroups (PI-RADS 2-3 vs. 4-5);
- Proportion of patients with additional csPCa lesions detected only on delayed imaging;
- Proportion of patients whose management would change after incorporating delayed results;
- Exploratory subgroup analyses by PSA level, PSA density, and combined gray-zone subgroups.
Statistical Analysis The primary analysis will compare paired AUCs using the DeLong test . Secondary analyses will use appropriate paired tests with adjustment for multiple comparisons. Missing data will be handled by complete-case analysis.
Data Monitoring An independent data monitor reviews data integrity and protocol adherence. No interim analysis is planned. The study complies with the Declaration of Helsinki and local regulations.
- Being tested
- [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only Acquisition
- Keywords
- Prostate Cancer, PSMA PET, Delayed imaging, Diagnostic, Efficacy
- 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.
[⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only AcquisitionDiagnostic test
All enrolled patients undergo a dual-phase PSMA PET/CT imaging protocol consisting of: (1) a standard whole-body PET/CT acquisition performed at approximately 60 minutes after intravenous administration of [⁶⁸Ga]Ga-PSMA-11; and (2) a delayed pelvic PET acquisition performed at approximately 2-3 hours post-injection (exact timing to be standardized across participating centers based on local protocols and clinical workflow). The delayed phase does not include a separate CT scan; images are reconstructed using the CT dataset obtained from the initial whole-body acquisition for attenuation correction.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | All enrolled patients with suspected prostate cancer undergo both standard and delayed PSMA PET imaging. Each patient serves as their own control, with diagnostic performance compared between the standard imaging phase and the delayed imaging phase. Receives: Diagnostic Test: [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Delayed SUVmax vs. Standard SUVmax for csPCa
Compare the AUC of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (ISUP grade group ≥2) using the DeLong test , to determine whether delayed imaging is superior.
Measured: [Time Frame: Baseline (comparison of standard vs. delayed images)]
Secondary outcomes (9)
Optimal Threshold of Delayed SUVmax for csPCa
Determine the optimal cutoff of delayed SUVmax for diagnosing clinically significant prostate cancer using ROC analysis with the Youden index.
Measured: Baseline
Optimal Threshold of ΔSUVmax (Delayed Minus Standard) for csPCa
Calculate ΔSUVmax (delayed SUVmax minus standard SUVmax) and determine its optimal percentage-change cutoff for diagnosing clinically significant prostate cancer using ROC analysis with the Youden index.
Measured: Baseline
Diagnostic Performance of Optimal Thresholds in Validation Cohort
Apply the derived thresholds to a temporally separate validation set to assess sensitivity, specificity, and AUC.
Measured: Baseline
Negative Predictive Value for Biopsy Avoidance in PI-RADS 4-5 Patients
In patients with PI-RADS 4-5 lesions, calculate the negative predictive value using a predefined high threshold to estimate the proportion who could safely avoid biopsy.
Measured: Baseline
AUC of Delayed vs. Standard Imaging in PI-RADS 2-3 and PI-RADS 4-5 Subgroups
Compare the AUC of delayed Imaging versus standard SUVmax for csPCa detection separately in patients with PI-RADS 2-3 (target of PRIMARY2 study) and PI-RADS 4-5.
Measured: Baseline
Proportion of Patients with Additional csPCa Lesions Detected Only on Delayed Imaging
Calculate the proportion of patients who have additional csPCa lesions identified exclusively on delayed images that were not seen on standard images.
Measured: Baseline
Proportion of Patients with Change in Clinical Management After Delayed Imaging ( Exploratory)
Proportion of patients for whom management recommendations (biopsy vs. surveillance) would change after incorporating delayed imaging results, compared with standard imaging alone.
Measured: Baseline
Exploratory Subgroup Analyses by PSA and PSAD
Compare AUC of delayed vs. standard SUVmax for csPCa detection stratified by PSA level (<4, 4-10, >10 ng/mL) and PSA density (<0.10, 0.10-0.20, >0.20 ng/mL/cc); additionally explore combined gray-zone subgroups (e.g., PI-RADS 3 with PSA 4-10 or PSAD 0.10-0.20).
Measured: Baseline
Inter-Observer Agreement for SUVmax Measurement of the Most Suspicious Intraprostatic Lesion on Standard and Delayed PSMA PET/CT (Intraclass Correlation Coefficient, ICC, Exploratory)
Two nuclear medicine physicians independently identify the most suspicious intraprostatic lesion on both standard and delayed images and measure its maximum standardized uptake value (SUVmax) once per lesion. Inter-observer agreement for SUVmax measurement will be assessed using the intraclass correlation coefficient (ICC, two-way random model, absolute agreement). ICC values with 95% confidence intervals will be reported separately for standard and delayed imaging. Higher ICC indicates better measurement consistency.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start5 Mar 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion5 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-naive 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China, National Translational Science Center for Molecular Medicine, Shaanxi Provincial People's Hospital, Weinan Central Hospital, Yan'an University Affiliated Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, LanZhou University, Affiliated Hospital of Qinghai University, General Hospital of Ningxia Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531329
- Sponsor's protocol ID
- KY20262036-F-1
- Acronym
- DEPICT
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer
- ClinicalTrials.gov ID
- NCT07531329
- Acronym / sponsor ID
- DEPICT / KY20262036-F-1
- Keywords
- Prostate Cancer, PSMA PET, Delayed imaging, Diagnostic, Efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China, National Translational Science Center for Molecular Medicine, Shaanxi Provincial People's Hospital, Weinan Central Hospital, Yan'an University Affiliated Hospital, The Second Affiliated Hospital of Shaanxi University of Chinese Medicine, LanZhou University, Affiliated Hospital of Qinghai University, General Hospital of Ningxia Medical University
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 5 Mar 2028 (estimated)
- First posted
- 15 Apr 2026 (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.
Brief Summary This prospective, multicenter study evaluates whether delayed PSMA PET imaging improves diagnostic efficacy for detecting clinically significant prostate cancer (Gleason score ≥7) compared with standard imaging in patients with suspected newly diagnosed prostate cancer. Each patient serves as their own control, with diagnostic performance compared between standard (60-minute) and delayed (2-3 hour) acquisitions.
Background PSMA PET has transformed prostate cancer imaging, with emerging evidence suggesting delayed acquisition may further improve diagnostic accuracy by increasing tumor-to-background ratio. Recent studies demonstrate that delayed imaging significantly reduces equivocal findings and enhances detection of clinically significant prostate cancer.
Need While standard PSMA PET is well-validated, prospective multicenter data specifically evaluating the incremental diagnostic value of delayed imaging for clinically significant prostate cancer in treatment-naïve patients are lacking. This study addresses this gap by systematically comparing standard and delayed imaging in a large, well-defined cohort.
Primary Outcome The primary outcome is to compare the area under the curve (AUC) of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (csPCa), and to determine whether delayed imaging is superior to standard imaging.
Secondary Outcomes
- Optimal diagnostic thresholds for delayed imaging
- Determine the optimal threshold for delayed SUVmax using ROC analysis with the Youden index;
- Determine the optimal threshold for ΔSUVmax (delayed minus standard SUVmax);
- Validate the sensitivity, specificity, and AUC of these thresholds in an independent validation set.
- Biopsy avoidance potential In patients with PI RADS 4-5 lesions, calculate the negative predictive value (NPV) using a predefined high threshold to estimate the proportion who could safely avoid biopsy.
- Diagnostic performance in key subgroups Compare the AUC of delayed SUVmax versus standard SUVmax for csPCa detection in patients with PI RADS 2-3 and in those with PI RADS 4-5.
- Additional lesion detection Proportion of patients with additional csPCa lesions detected only on delayed imaging, and the proportion whose PI RADS category would be upgraded based on these findings.
- Clinical decision impact Proportion of patients in whom management recommendations would change after incorporating delayed imaging results, compared with standard imaging alone.
- Exploratory subgroup analyses Stratify by PSA level (<4, 4 10, >10 ng/mL) and PSA density (<0.10, 0.10-0.20, >0.20 ng/mL/cc) to identify subgroups that derive the greatest benefit from delayed imaging; additionally, explore combined subgroups such as PI RADS 3 with PSA 4-10 or PSAD 0.10-0.20.
Inclusion Criteria
- Suspected prostate cancer based on elevated PSA (≥4.0 ng/mL) or clinical symptoms
- Undergo PSMA PET (standard + delayed) prior to prostate biopsy
- Willing to undergo prostate biopsy
- Provide written informed consent Exclusion Criteria
- Prior prostate cancer treatment before PSMA PET imaging 2. Other malignancy within past two years 3. Investigator-judged risk of serious complications interfering with study conduct
Detailed description
Study Design and Objective This is a prospective, multicenter diagnostic accuracy study designed to evaluate whether delayed PSMA PET imaging improves diagnostic efficacy for clinically significant prostate cancer (csPCa) compared with standard imaging in patients with suspected newly diagnosed, treatment-naïve prostate cancer. Each patient serves as their own control.
Imaging Protocol
All enrolled patients undergo dual-time-point PSMA PET/CT before biopsy:
- Standard acquisition: whole-body imaging at approximately 60 minutes post-injection.
- Delayed acquisition: pelvic-focused imaging at 2-3 hours post-injection.
Reference Standard All patients undergo prostate biopsy using 12-core systematic biopsy plus targeted biopsy when indicated. Histopathology serves as the reference standard. csPCa is defined as ISUP grade group ≥2.
Primary Outcome To compare the area under the receiver operating characteristic curve (AUC) of delayed SUVmax versus standard SUVmax for detecting csPCa, and to determine whether delayed imaging is superior to standard imaging.
Secondary Outcomes
- Optimal diagnostic thresholds for delayed SUVmax and ΔSUVmax, with internal validation;
- Negative predictive value (NPV) and biopsy avoidance potential (especially in PI-RADS 4-5 patients);
- Diagnostic performance in key subgroups (PI-RADS 2-3 vs. 4-5);
- Proportion of patients with additional csPCa lesions detected only on delayed imaging;
- Proportion of patients whose management would change after incorporating delayed results;
- Exploratory subgroup analyses by PSA level, PSA density, and combined gray-zone subgroups.
Statistical Analysis The primary analysis will compare paired AUCs using the DeLong test . Secondary analyses will use appropriate paired tests with adjustment for multiple comparisons. Missing data will be handled by complete-case analysis.
Data Monitoring An independent data monitor reviews data integrity and protocol adherence. No interim analysis is planned. The study complies with the Declaration of Helsinki and local regulations.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Diagnostic Test: [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only AcquisitionAll enrolled patients with suspected prostate cancer undergo both standard and delayed PSMA PET imaging. Each patient serves as their own control, with diagnostic performance compared between the standard imaging phase and the delayed imaging phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of a consecutive series of patients with suspected prostate cancer based on elevated PSA levels (≥4.0 ng/mL) who are referred for initial diagnostic evaluation at participating centers. All enrolled patients undergo dual-phase [⁶⁸Ga]Ga-PSMA-11 PET/CT imaging (standard whole-body acquisition at approximately 60 minutes post-injection, followed by delayed pelvic PET acquisition at approximately 2-3 hours post-injection) prior to transrectal or transperineal prostate biopsy. Eligible patients must have no prior history of prostate cancer-related treatment and no other active malignancy within the past two years. This prospective cohort represents a typical diagnostic population in whom the incremental value of delayed PSMA PET imaging for prostate cancer detection is being investigated.
Key inclusion criteria (4 listed)
- Patients with suspected prostate cancer and a PSA level ≥4.0 ng/mL
- Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy
- Patients who are willing to undergo prostate biopsy
- Patients who provide written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan
- Patients with a history of other malignancies within the past two years
- Patients judged by the study investigator to be at risk for serious complications that could interfere with the normal conduct of the study
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 |
|---|---|---|
| [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only AcquisitionAll enrolled patients undergo a dual-phase PSMA PET/CT imaging protocol consisting of: (1) a standard whole-body PET/CT acquisition performed at approximately 60 minutes after intravenous administration of [⁶⁸Ga]Ga-PSMA-11; and (2) a delayed pelvic PET acquisition performed at approximately 2-3 hours post-injection (exact timing to be standardized across participating centers based on local protocols and clinical workflow). The delayed phase does not include a separate CT scan; images are reconstructed using the CT dataset obtained from the initial whole-body acquisition for attenuation correction. | Diagnostic test | Study Cohort |
Primary outcome
Area Under the Curve (AUC) of Delayed SUVmax vs. Standard SUVmax for csPCa
Time frame: [Time Frame: Baseline (comparison of standard vs. delayed images)]
Compare the AUC of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (ISUP grade group ≥2) using the DeLong test , to determine whether delayed imaging is superior.
9 secondary outcomes
Optimal Threshold of Delayed SUVmax for csPCa
Time frame: Baseline
Optimal Threshold of ΔSUVmax (Delayed Minus Standard) for csPCa
Time frame: Baseline
Diagnostic Performance of Optimal Thresholds in Validation Cohort
Time frame: Baseline
Negative Predictive Value for Biopsy Avoidance in PI-RADS 4-5 Patients
Time frame: Baseline
AUC of Delayed vs. Standard Imaging in PI-RADS 2-3 and PI-RADS 4-5 Subgroups
Time frame: Baseline
Proportion of Patients with Additional csPCa Lesions Detected Only on Delayed Imaging
Time frame: Baseline
Proportion of Patients with Change in Clinical Management After Delayed Imaging ( Exploratory)
Time frame: Baseline
Exploratory Subgroup Analyses by PSA and PSAD
Time frame: Baseline
Inter-Observer Agreement for SUVmax Measurement of the Most Suspicious Intraprostatic Lesion on Standard and Delayed PSMA PET/CT (Intraclass Correlation Coefficient, ICC, Exploratory)
Time frame: Baseline
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment-naive Prostate Cancer and Suspected Prostate Cancer, run by Xijing Hospital at 9 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Jianhua Jiao, MD. (+86 18700919857, 1531769428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of Delayed SUVmax vs. Standard SUVmax for csPCa (time frame: [Time Frame: Baseline (comparison of standard vs. delayed images)]). 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 15 Apr 2026.