An observational study in Prostate Cancer and Prostatic Neoplasms, sponsored by Guangxi Medical University. Active, not recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Guangxi Medical University · Observational
Prostate cancer is a major malignancy in men, and prostate biopsy determines both cancer detection and risk stratification. Biopsy strategies vary substantially across centers in approach (transperineal vs. transrectal), use of multiparametric MRI (mpMRI), targeted versus systematic sampling, and the spatial distribution of cores; however, most prior databases record only the total number of cores and cannot reconstruct the spatial location of individual cores. This national multicenter, retrospective, non-interventional observational cohort study, led by Guangxi Medical University and involving more than 20 hospitals across more than 10 provinces in China, will establish a layered database linking patients, MRI lesions, biopsy events, actual needle passes/specimen jars/cores, and radical prostatectomy pathology, and will convert historical needle-placement strategies into unified, auditable spatial variables. The study aims to compare the detection rate and per-core detection efficiency of ISUP Grade Group (GG) >=2 prostate cancer across different spatial needle-placement strategies, to estimate the absolute missed-cancer cost and core-saving benefit of candidate reduced templates through within-patient reconstruction, and to evaluate the concordance, upgrading, and downgrading between biopsy and radical prostatectomy GG. The study adds no tests, biopsies, treatment, or follow-up, and the main risks are privacy breach and data misuse. Target enrollment is at least 30,000 cases.
Background: Prostate cancer is the second most common malignancy in men worldwide. GLOBOCAN 2022 estimated about 1.468 million new cases and 397,000 deaths globally, and about 134,000 new cases and 48,000 deaths in China. Biopsy directly affects detection of clinically significant prostate cancer (csPCa) and choices of active surveillance or definitive treatment. Conventional systematic biopsy samples by anatomical zones with a fixed number of cores, yet tumors are multifocal and spatially heterogeneous, so the same total core count may correspond to markedly different coverage of anterior, posterior, apical, basal, peripheral-zone, and transition-zone regions. Although mpMRI and targeted biopsy have entered clinical pathways, and combined targeted plus systematic sampling is common, evidence on which anatomical regions to cover, the extent of perilesional sampling, and how many systematic cores to retain in different risk strata remains limited, especially across China with a unified spatial ontology and core-level quality control. A second challenge is the discordance between biopsy Grade Group and whole-gland radical prostatectomy pathology.
Design: This is a national multicenter, retrospective, non-interventional observational cohort study. More than 20 hospitals covering more than 10 provinces will contribute at least 30,000 consecutive audited cases. The lead center's retrospective data window is January 2015 to October 2026; each participating center's window will cover a consecutive, verifiable period specified in its site agreement and ethics materials. Four nested analysis cohorts are defined: (A) all eligible biopsy events, for the national strategy map and observed detection; (B) those with interpretable MRI/PI-RADS data, for MRI risk stratification; (C) those with localizable cores and strategy maps, for within-patient template reconstruction; and (D) those who underwent radical prostatectomy with matched biopsy-surgery pathology, for GG concordance, upgrading, and downgrading. First biopsies form the main cohort; subsequent biopsies of the same patient are recorded as independent events in a prespecified repeat-biopsy cohort.
Spatial definitions and reconstruction: Perilesional cores are defined by the shortest distance from a non-targeted needle trajectory to the three-dimensional MRI lesion boundary rather than by zone: within the boundary is targeted; outside the boundary, \<=10 mm is perilesional (subdivided into 0-5 mm and >5-10 mm), >10-15 mm is extended-near, and >15 mm is remote. Within-patient template reconstruction uses all actually obtained, localizable cores as the observable set and simulates retaining targeted-only, targeted plus perilesional, targeted plus ipsilateral systematic, or targeted plus bilateral systematic cores, calculating cores saved, GG>=2/GG>=3 missed, and GG1 reduction. This paired analysis does not assume unsampled tissue is negative.
Analysis and boundaries: Detection outcomes are defined by biopsy pathology in the full biopsy cohort; whole-gland pathology is used only in the selective surgery subcohort, and absence of surgery is not treated as negative. The study reports observed detection rates, incremental detection, and the absolute omission cost of candidate reduced templates; it does not report traditional sensitivity, specificity, or negative predictive value in the full cohort because no uniform whole-gland reference standard exists. Analyses use center-clustered robust confidence intervals or multilevel models, generalized linear mixed models or marginal standardization for patient-level binary outcomes, nested core-level models, paired risk differences and McNemar tests with patient- and center-clustered bootstrap for within-patient reconstruction, and weighted kappa and confusion matrices for pathology concordance. The study follows STROBE, RECORD, START, and applicable STARD principles. No examinations, biopsies, treatment, or follow-up are added; the main risks are privacy breach and data misuse. Waiver of written informed consent is requested because the study uses only existing clinical data, imposes no intervention or physical risk, and re-contacting a large, geographically dispersed, long-period population is infeasible and would introduce selection bias, subject to de-identification, data minimization, access control, and audit.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Guangxi Medical University is the lead sponsor of 70 studies on the registry; 14 are open to participants now.
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Adult men (age >=18 years) who consecutively underwent transperineal or transrectal prostate biopsy within the ethics-approved time windows of more than 20 hospitals across more than 10 provinces in China. The lead center's data window is January 2015 to October 2026; each site's window covers a consecutive, verifiable period. Participants are identified through hospital information, pathology, imaging, and surgical records; no recruitment advertising, no proactive patient contact, and no change to clinical care occur. Participants must have interpretable biopsy pathology uniquely matchable to the patient and biopsy event. Four nested analysis cohorts are defined: all eligible biopsy events (A), those with interpretable MRI/PI-RADS (B), those with localizable cores and strategy maps (C), and those with matched radical prostatectomy pathology (D). First biopsies form the main cohort; repeat biopsies are recorded as independent events. Target enrollment is at least 30,000 cases.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All eligible prostate biopsy events; used for the national strategy map and observed detection outcomes defined by biopsy pathology.
Patients with interpretable MRI/PI-RADS data; used for MRI risk stratification and interaction analyses.
Patients with localizable cores and strategy maps; used for within-patient template reconstruction of core-saving and omission costs.
Patients who underwent radical prostatectomy with matched biopsy-surgery pathology and no histology-altering preoperative treatment in the main analysis; used for GG concordance, upgrading, and downgrading.
Grade Group >=2 Prostate Cancer Detection Rate
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 (%).
Time frame: At biopsy (biopsy pathology)
Per-Needle-Pass Grade Group >=2 Detection Efficiency
Number of GG\>=2 prostate cancer detections per needle pass. Unit of measure: GG\>=2 detections per needle pass.
Time frame: At biopsy
Absolute Grade Group >=2 Omission Rate of Candidate Reduced Templates
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 (%).
Time frame: At biopsy (within-patient reconstruction)
Biopsy-Radical Prostatectomy Grade Group Concordance
Concordance rate, upgrading rate, and downgrading rate between biopsy GG and radical prostatectomy GG in the surgery cohort. Unit of measure: Percentage (%).
Time frame: At radical prostatectomy (paired with biopsy)
Detection Rates of Grade Group >=3, Any Prostate Cancer, and Grade Group 1
Detection rates of GG\>=3, any prostate cancer, and GG1 cancer. Unit of measure: Percentage (%).
Time frame: At biopsy
Core-Saving Benefit and Net Benefit of Reduced Templates
Number of cores saved, number of cores needed per additional GG\>=2 detected, and net benefit. Unit of measure: Number of cores / net benefit.
Time frame: At biopsy (within-patient reconstruction)
Anatomical Region-Specific csPCa Detection and Omission
csPCa detection, omission, and pathology upgrading/downgrading by anatomical region (PZ, TZ, anterior, posterior, apical, basal, left/right). Unit of measure: Percentage (%).
Time frame: At biopsy and at radical prostatectomy
Stratified Outcomes by Clinical and Imaging Factors
Stratified results by PI-RADS, PSAD, lesion size, biopsy approach, and repeat biopsy. Unit of measure: Percentage (%).
Time frame: At biopsy
Weighted Kappa for Biopsy-Radical Prostatectomy Concordance
Weighted kappa, linear weighted kappa, and GG confusion matrix between biopsy and radical prostatectomy. Unit of measure: Kappa value / counts.
Time frame: At radical prostatectomy
Effect Modification of Strategy Effectiveness
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).
Time frame: At biopsy
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Guangxi Medical University