Prostate CancerNCT07918235
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
An observational study of Prostate Cancer and Prostatic Neoplasms, run by Guangxi Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2029
- 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: 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.
Who may be able to join
- Age >=18 years at the time of biopsy.
- Underwent transperineal or transrectal prostate biopsy within the time window specified by the participating center.
- Interpretable biopsy pathology results available, uniquely matchable to the patient and the biopsy event.
- At minimum, the center, a de-identified within-center patient number, the biopsy date or orderable time information, and interpretable biopsy pathology are available. Missing biopsy approach, total needle passes, specimen jars, or core counts does not prevent entry into the patient-level detection cohort but determines eligibility for strategy, per-core efficiency, or spatial analyses.
- Meets the additional data requirements of the corresponding analysis cohort; lack of MRI or radical prostatectomy data does not affect entry into the full biopsy cohort.
Who cannot join
- Only a consultation summary or conclusion is available, without confirmation that the biopsy was actually performed or without matchable pathology.
- All specimens from the entire biopsy event are indeterminate lesions with no subsequent evidence confirming cancer or non-cancer, so the patient-level outcome cannot be determined. (If only individual cores are indeterminate while other cores have definite cancer or non-cancer evidence, the patient is retained and the core is separately marked as unclassifiable.)
- Conflicts in key identity or dates prevent de-duplication or determination of biopsy sequence.
- Biopsy performed after radical treatment for prostate cancer, or other sampling not fitting the prespecified clinical scenario.
- The center cannot provide minimum data-quality certification, or ethics/data-use authorization does not cover the research use.
- Cross-center visits may cause the same patient to appear more than once; centers de-duplicate locally, and the lead center does not receive direct identifiers. If ethics- and data-security-approved, irreversible salted hashing or a trusted third party may be used for cross-center suspected-duplicate checks; otherwise this is treated as a limitation with sensitivity analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National Multicenter, Retrospective, Non-Interventional Observational Cohort Study of Spatial Needle Placement Strategies, Diagnostic Efficacy, Within-Patient Core Template Reconstruction, and Biopsy-Radical Prostatectomy Pathological Concordance in Prostate Cancer Across China
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- prostate biopsy, multiparametric MRI, PI-RADS, Grade Group, targeted biopsy, systematic biopsy, spatial needle placement
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Full Biopsy Cohort (Cohort A) | All eligible prostate biopsy events; used for the national strategy map and observed detection outcomes defined by biopsy pathology. | |
| MRI-Evaluable Cohort (Cohort B) | Patients with interpretable MRI/PI-RADS data; used for MRI risk stratification and interaction analyses. | |
| Core-Level Reconstructable Cohort (Cohort C) | Patients with localizable cores and strategy maps; used for within-patient template reconstruction of core-saving and omission costs. | |
| Radical Prostatectomy Cohort (Cohort D) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: At radical prostatectomy (paired with biopsy)
Secondary outcomes (5)
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 (%).
Measured: 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.
Measured: 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 (%).
Measured: 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 (%).
Measured: 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.
Measured: At radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startJan 2015
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fubo Wang, Guangxi Medical University
- Investigators
- Fubo Wang, Principal investigator, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918235
- Sponsor's protocol ID
- GXMU-IRB-APR-2026-096
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751International Agency for Research on Cancer. Global Cancer Observatory: China Fact Sheet, GLOBOCAN 2022 (Version 1.1). Lyon: IARC; 2024.
Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
PubMed 28110982Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
PubMed 29552975Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
PubMed 30470502van der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23.
PubMed 30477981Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.
PubMed 32130814Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019 Apr 25;4(4):CD012663. doi: 10.1002/14651858.CD012663.pub2.
PubMed 31022301European Association of Urology. EAU Guidelines on Prostate Cancer: Diagnostic Evaluation. European Association of Urology; 2024.
Wei JT, Barocas D, Carlsson S, Coakley F, Eggener S, Etzioni R, Fine SW, Han M, Kim SK, Kirkby E, Konety BR, Miner M, Moses K, Nissenberg MG, Pinto PA, Salami SS, Souter L, Thompson IM, Lin DW. Early Detection of Prostate Cancer: AUA/SUO Guideline Part II: Considerations for a Prostate Biopsy. J Urol. 2023 Jul;210(1):54-63. doi: 10.1097/JU.0000000000003492. Epub 2023 Apr 25.
PubMed 37096575Hu JC, Assel M, Allaf ME, Ehdaie B, Vickers AJ, Cohen AJ, Ristau BT, Green DA, Han M, Rezaee ME, Pavlovich CP, Montgomery JS, Kowalczyk KJ, Ross AE, Kundu SD, Patel HD, Wang GJ, Graham JN, Shoag JE, Ghazi A, Singla N, Gorin MA, Schaeffer AJ, Schaeffer EM. Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial. Eur Urol. 2024 Jul;86(1):61-68. doi: 10.1016/j.eururo.2023.12.015. Epub 2024 Jan 11.
PubMed 38212178National Health Commission Of The People's Republic Of China. National guidelines for diagnosis and treatment of cervical cancer 2022 in China (English version). Chin J Cancer Res. 2022 Jun 30;34(3):256-269. doi: 10.21147/j.issn.1000-9604.2022.03.06. No abstract available.
PubMed 35873886Song G, et al. Indications, strategies, and development on prostate targeted biopsy: Report of the Panjiayuan Consensus Conference 2022. UroPrecision. 2023;1(1):58-72.
Cheng Y, Huang H, Wang M, Zhu L, Peng S, Li D, Marra G, Qi R, Ding X, Liu M, Qiu X, Guo H. Magnetic resonance imaging-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: A multicenter, paired, noninferiority, observational trial. Cancer. 2026 Jul 1;132(13):e70493. doi: 10.1002/cncr.70493.
PubMed 42319125Buhas BA, Mjaess G, Diamand R, Peyrottes A, Uleri A, Baboudjian M, Brown JA, Abou Chakra M, Borz MB, Crisan N, Baudewyns A, Jabbour T, Jeglinschi S, Iancu M, Ploussard G. Risk-adapted Omission of Systematic Cores in PI-RADS 3 Lesions Based on Prostate-specific Antigen Density, Biopsy Route, and Targeted Core Number: A Multicentre Cohort Study. Eur Urol Oncol. 2026 Jul 30:S2588-9311(26)00193-8. doi: 10.1016/j.euo.2026.07.003. Online ahead of print.
PubMed 42532809
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter, Retrospective, Non-Interventional Observational Cohort Study of Spatial Needle Placement Strategies, Diagnostic Efficacy, Within-Patient Core Template Reconstruction, and Biopsy-Radical Prostatectomy Pathological Concordance in Prostate Cancer Across China
- ClinicalTrials.gov ID
- NCT07918235
- Acronym / sponsor ID
- GXMU-IRB-APR-2026-096
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Keywords
- prostate biopsy, multiparametric MRI, PI-RADS, Grade Group, targeted biopsy, systematic biopsy, spatial needle placement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 Nov 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full Biopsy Cohort (Cohort A) | – | –All eligible prostate biopsy events; used for the national strategy map and observed detection outcomes defined by biopsy pathology. |
| MRI-Evaluable Cohort (Cohort B) | – | –Patients with interpretable MRI/PI-RADS data; used for MRI risk stratification and interaction analyses. |
| Core-Level Reconstructable Cohort (Cohort C) | – | –Patients with localizable cores and strategy maps; used for within-patient template reconstruction of core-saving and omission costs. |
| Radical Prostatectomy Cohort (Cohort D) | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Age >=18 years at the time of biopsy.
- Underwent transperineal or transrectal prostate biopsy within the time window specified by the participating center.
- Interpretable biopsy pathology results available, uniquely matchable to the patient and the biopsy event.
- At minimum, the center, a de-identified within-center patient number, the biopsy date or orderable time information, and interpretable biopsy pathology are available. Missing biopsy approach, total needle passes, specimen jars, or core counts does not prevent entry into the patient-level detection cohort but determines eligibility for strategy, per-core efficiency, or spatial analyses.
- Meets the additional data requirements of the corresponding analysis cohort; lack of MRI or radical prostatectomy data does not affect entry into the full biopsy cohort.
Key exclusion criteria (6 listed)
- Only a consultation summary or conclusion is available, without confirmation that the biopsy was actually performed or without matchable pathology.
- All specimens from the entire biopsy event are indeterminate lesions with no subsequent evidence confirming cancer or non-cancer, so the patient-level outcome cannot be determined. (If only individual cores are indeterminate while other cores have definite cancer or non-cancer evidence, the patient is retained and the core is separately marked as unclassifiable.)
- Conflicts in key identity or dates prevent de-duplication or determination of biopsy sequence.
- Biopsy performed after radical treatment for prostate cancer, or other sampling not fitting the prespecified clinical scenario.
- The center cannot provide minimum data-quality certification, or ethics/data-use authorization does not cover the research use.
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
Grade Group >=2 Prostate Cancer Detection Rate
Time frame: At 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 (%).
Per-Needle-Pass Grade Group >=2 Detection Efficiency
Time frame: At biopsy
Number of GG>=2 prostate cancer detections per needle pass. Unit of measure: GG>=2 detections per needle pass.
Absolute Grade Group >=2 Omission Rate of Candidate Reduced Templates
Time frame: At 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 (%).
Biopsy-Radical Prostatectomy Grade Group Concordance
Time frame: At 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 (%).
5 secondary outcomes
Detection Rates of Grade Group >=3, Any Prostate Cancer, and Grade Group 1
Time frame: At biopsy
Core-Saving Benefit and Net Benefit of Reduced Templates
Time frame: At biopsy (within-patient reconstruction)
Anatomical Region-Specific csPCa Detection and Omission
Time frame: At biopsy and at radical prostatectomy
Stratified Outcomes by Clinical and Imaging Factors
Time frame: At biopsy
Weighted Kappa for Biopsy-Radical Prostatectomy Concordance
Time frame: At radical prostatectomy
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 5 Nov 2026.
- Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- BackgroundInternational Agency for Research on Cancer. Global Cancer Observatory: China Fact Sheet, GLOBOCAN 2022 (Version 1.1). Lyon: IARC; 2024.
- Background: PubMed 28110982Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.
- Background: PubMed 29552975Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
- Background: PubMed 30470502Rouviere O, Puech P, Renard-Penna R, Claudon M, Roy C, Mege-Lechevallier F, Decaussin-Petrucci M, Dubreuil-Chambardel M, Magaud L, Remontet L, Ruffion A, Colombel M, Crouzet S, Schott AM, Lemaitre L, Rabilloud M, Grenier N; MRI-FIRST Investigators. Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol. 2019 Jan;20(1):100-109. doi: 10.1016/S1470-2045(18)30569-2. Epub 2018 Nov 21.
- Background: PubMed 30477981van der Leest M, Cornel E, Israel B, Hendriks R, Padhani AR, Hoogenboom M, Zamecnik P, Bakker D, Setiasti AY, Veltman J, van den Hout H, van der Lelij H, van Oort I, Klaver S, Debruyne F, Sedelaar M, Hannink G, Rovers M, Hulsbergen-van de Kaa C, Barentsz JO. Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naive Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study. Eur Urol. 2019 Apr;75(4):570-578. doi: 10.1016/j.eururo.2018.11.023. Epub 2018 Nov 23.
- Background: PubMed 32130814Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.
- Background: PubMed 31022301Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019 Apr 25;4(4):CD012663. doi: 10.1002/14651858.CD012663.pub2.
- BackgroundEuropean Association of Urology. EAU Guidelines on Prostate Cancer: Diagnostic Evaluation. European Association of Urology; 2024.
- Background: PubMed 37096575Wei JT, Barocas D, Carlsson S, Coakley F, Eggener S, Etzioni R, Fine SW, Han M, Kim SK, Kirkby E, Konety BR, Miner M, Moses K, Nissenberg MG, Pinto PA, Salami SS, Souter L, Thompson IM, Lin DW. Early Detection of Prostate Cancer: AUA/SUO Guideline Part II: Considerations for a Prostate Biopsy. J Urol. 2023 Jul;210(1):54-63. doi: 10.1097/JU.0000000000003492. Epub 2023 Apr 25.
- Background: PubMed 38212178Hu JC, Assel M, Allaf ME, Ehdaie B, Vickers AJ, Cohen AJ, Ristau BT, Green DA, Han M, Rezaee ME, Pavlovich CP, Montgomery JS, Kowalczyk KJ, Ross AE, Kundu SD, Patel HD, Wang GJ, Graham JN, Shoag JE, Ghazi A, Singla N, Gorin MA, Schaeffer AJ, Schaeffer EM. Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial. Eur Urol. 2024 Jul;86(1):61-68. doi: 10.1016/j.eururo.2023.12.015. Epub 2024 Jan 11.
- Background: PubMed 35873886National Health Commission Of The People's Republic Of China. National guidelines for diagnosis and treatment of cervical cancer 2022 in China (English version). Chin J Cancer Res. 2022 Jun 30;34(3):256-269. doi: 10.21147/j.issn.1000-9604.2022.03.06. No abstract available.
- 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. This study is not recruiting at the moment.
Fubo Wang principal investigator
Guangxi Medical University
1 site 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 and Prostatic Neoplasms, run by Guangxi Medical University at 1 site 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Grade Group >=2 Prostate Cancer Detection Rate (time frame: At biopsy (biopsy pathology)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07918235, which also lists 23 linked publications.
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 5 Nov 2026.