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Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study

NCT07918235, Active not recruiting, Guangxi Medical University

Trial 8

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleSpatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort StudyClinicalTrials.gov
NCT numberNCT07918235ClinicalTrials.gov
StatusActive not recruitingClinicalTrials.gov
Enrollment30,000 participants, estimatedClinicalTrials.gov
Lead sponsorGuangxi Medical UniversityClinicalTrials.gov
ConditionsProstate Cancer, Prostatic NeoplasmsClinicalTrials.gov
First posted2026-11-05ClinicalTrials.gov
Last updated2026-11-05ClinicalTrials.gov

Registered outcomes 10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryGrade Group >=2 Prostate Cancer Detection RateAt biopsy (biopsy pathology)
Observed detection rate of ISUP Grade Group (GG) \>=2 prostate cancer across different spatial needle-placement strategies in the full biopsy cohort, with adjusted absolute risk differences. Unit of measure: Percentage (%).
ClinicalTrials.gov
PrimaryPer-Needle-Pass Grade Group >=2 Detection EfficiencyAt biopsyNumber of GG\>=2 prostate cancer detections per needle pass. Unit of measure: GG\>=2 detections per needle pass.ClinicalTrials.gov
PrimaryAbsolute Grade Group >=2 Omission Rate of Candidate Reduced TemplatesAt biopsy (within-patient reconstruction)Absolute GG\>=2 omission rate of candidate reduced templates relative to the complete observable core set in the core-level cohort. Unit of measure: Percentage (%).ClinicalTrials.gov
PrimaryBiopsy-Radical Prostatectomy Grade Group ConcordanceAt radical prostatectomy (paired with biopsy)Concordance rate, upgrading rate, and downgrading rate between biopsy GG and radical prostatectomy GG in the surgery cohort. Unit of measure: Percentage (%).ClinicalTrials.gov
SecondaryDetection Rates of Grade Group >=3, Any Prostate Cancer, and Grade Group 1At biopsyDetection rates of GG\>=3, any prostate cancer, and GG1 cancer. Unit of measure: Percentage (%).ClinicalTrials.gov
SecondaryCore-Saving Benefit and Net Benefit of Reduced TemplatesAt biopsy (within-patient reconstruction)Number of cores saved, number of cores needed per additional GG\>=2 detected, and net benefit. Unit of measure: Number of cores / net benefit.ClinicalTrials.gov
SecondaryAnatomical Region-Specific csPCa Detection and OmissionAt biopsy and at radical prostatectomycsPCa detection, omission, and pathology upgrading/downgrading by anatomical region (PZ, TZ, anterior, posterior, apical, basal, left/right). Unit of measure: Percentage (%).ClinicalTrials.gov
SecondaryStratified Outcomes by Clinical and Imaging FactorsAt biopsyStratified results by PI-RADS, PSAD, lesion size, biopsy approach, and repeat biopsy. Unit of measure: Percentage (%).ClinicalTrials.gov
SecondaryWeighted Kappa for Biopsy-Radical Prostatectomy ConcordanceAt radical prostatectomyWeighted kappa, linear weighted kappa, and GG confusion matrix between biopsy and radical prostatectomy. Unit of measure: Kappa value / counts.ClinicalTrials.gov
OtherEffect Modification of Strategy EffectivenessAt biopsy
Effect modification by PI-RADS, PSAD, lesion size, prior negative biopsy, prostate volume, and biopsy approach on the effectiveness of needle-placement strategies (interaction analyses with prespecified direction and absolute effects).
ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 20

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
18064739BACKGROUNDPubMed
23537686BACKGROUNDPubMed
26440803BACKGROUNDPubMed
26511519BACKGROUNDPubMed
28110982BACKGROUNDPubMed
29552975BACKGROUNDPubMed
30470502BACKGROUNDPubMed
30477882BACKGROUNDPubMed
30477981BACKGROUNDPubMed
31022301BACKGROUNDPubMed
31492650BACKGROUNDPubMed
32130814BACKGROUNDPubMed
35873886BACKGROUNDPubMed
37096575BACKGROUNDPubMed
37236832BACKGROUNDPubMed
38212178BACKGROUNDPubMed
38572751BACKGROUNDPubMed
42190047BACKGROUNDPubMed
42319125BACKGROUNDPubMed
42532809BACKGROUNDPubMed

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)