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 2026-11-13.
Sponsored by Guangxi Medical University · Observational
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Among 541 studies in Prostatic Neoplasms with a site in China — 281 open to participants now, 342 under way, 51 of them phase 3. Prostatic Neoplasms · China.
Among the 541 studies in Prostatic Neoplasms with a site in China, this one is the 12th largest by planned enrollment of the 106 observational ones that give a count, is one of 8 that started in 2014, is one of 106 observational ones, reaches primary completion later than 317 of the 341 other live ones, and was the 539th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →281 of the 541 studies in Prostatic Neoplasms with a site in China are open now. Recruiting first, the newest first:
The First Affiliated Hospital of Xiamen University · Sites in China
Ages 18+ · Men only
TransThera Sciences (Nanjing), Inc. · Sites in China
Ages 18+ · Men only
Janssen Research & Development, LLC · Sites in China, United States, Australia and 1 more country
Ages 18+ · Men only
AstraZeneca · Sites in China, United States, Austria and 18 more countries
Ages 18+ · Men only
FindCure Biosciences (ZhongShan) Co., Ltd. · Sites in China
Ages 18+ · Men only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
541 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 149 · Phase 2 146 · Phase 3 87 · Phase 4 7
First in 2003; this study’s year is marked. 8 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,000 is above the median of 200 across 1,309 observational studies indexed under Prostatic Neoplasms.
Median enrollment 100 across the 435 interventional studies, 300 across the 106 observational. Of the 110 that completed or were terminated, 23 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
199 of 541 have an industry lead sponsor. The 10 most frequent:
Guangxi Medical University is the lead sponsor of 71 studies on the registry; 14 are open to participants now.
Guangxi Medical University has 5 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
97 of the studies in Prostatic Neoplasms with a site in China that are under way reach primary completion within a year, 11 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03258320Phase 3Shanghai Jiao Tong University School of MedicineA Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients | 2026-12 |
| NCT04691804Phase 3Jiangsu HengRui Medicine Co., Ltd.A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer | 2026-12-31 |
| NCT06551324Phase 3PfizerA Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). | 2027-02-28 |
| NCT07241416Phase 3Jiangsu HengRui Medicine Co., Ltd.A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer | 2027-03 |
| NCT02531516Phase 3Aragon Pharmaceuticals, Inc.An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | 2027-03-01 |
Add all 97 to your calendar (.ics) → With an account.
Among the 541 studies in Prostatic Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an investigator-initiated, multicenter, observational ambispective cohort study, predominantly retrospective, with an optional prospective non-interventional silent validation. The study tests a cross-scale hypothesis that the pathological micro-niche of the primary prostate tumor (tumor epithelium, invasive front, immune-rich or immune-poor regions, ECM/collagen remodeling, neurovascular neighborhoods, and peritumoral field effect) is associated at the patient level with the imaging macro-niche captured by multiparametric MRI (diffusion, perfusion, heterogeneity, local invasion) and PSMA PET/CT (receptor expression, whole-body lesion distribution, tumor burden). A pathology teacher model provides patient- or lesion-set-level niche representations only during model development; at deployment and validation, only MRI, PSMA PET/CT, and clinical information available before the prediction time point are used, with no voxel-level pathology-to-imaging registration. Under one master protocol with three pre-specified substudies, the system predicts: (A) patient- and lesion-level clinically significant prostate cancer (csPCa, ISUP Grade Group 2 or higher) from pre-biopsy MRI; (B) pathological pelvic lymph node metastasis (pN1) after radical prostatectomy with pelvic lymph node dissection, primarily from MRI; and (C) concurrent distant metastasis (M1) and subsequent distant metastasis in baseline M0 patients, primarily from PSMA PET/CT. Models are evaluated for discrimination, calibration, clinical net benefit, uncertainty, abstention, and stability across centers, scanners, tracers, and disease spectra, using locked multicenter external validation and prospective silent validation. Model outputs are never shown to clinicians or patients and do not alter care.
BACKGROUND: Prostate cancer is one of the most common malignancies in men; GLOBOCAN 2022 estimates it accounts for about 7.3% of new cancers globally, with a rising burden in Asia. Clinical management spans three linked but differently referenced decisions: identifying clinically significant prostate cancer (csPCa) at initial workup; estimating pelvic lymph node risk before curative treatment; and detecting concurrent distant metastasis and predicting subsequent metastasis in high-risk patients. Multiparametric MRI is a key pre-biopsy triage tool (PROMIS, PRECISION), but its performance depends on scan quality, parameters, reader experience, lesion visibility, and the reference standard; a negative MRI cannot fully exclude csPCa. Imaging sensitivity for microscopic nodal disease is limited, and extended pelvic lymph node dissection (ePLND) adds burden; even PSMA PET/CT has a patient-level sensitivity of roughly 40% for pathological pelvic nodes in a prospective phase 3 study, so a negative result cannot replace adequate pathological staging. PSMA PET/CT is more accurate than conventional imaging for initial high-risk staging (proPSMA), and PROMISE V2 provides a standardized reporting framework, but PSMA uptake is not tumor-specific and micro-lesions, low expression, tracer differences, and treatment can cause misclassification. Existing AI models often learn imaging phenotype alone without systematically using pathology microenvironment information; single-center random splits cause center and leakage bias; and diagnostic AI frequently emphasizes discrimination over calibration, net benefit, abstention, drift, and workflow integration.
HYPOTHESIS: The pathological micro-niche of the primary tumor is associated at the patient level with MRI and PSMA PET/CT macro-niches. Introducing pathology niche representations through patient-level knowledge transfer that does not require voxel-level registration can improve csPCa, pelvic node, and distant metastasis risk estimates, with gains reproducible in centers not involved in development and in a prospective silent cohort (discrimination, calibration, and net benefit), not merely higher internal AUROC.
DESIGN: Investigator-initiated, multicenter, observational ambispective cohort under one master protocol with three pre-specified substudies (A, B, C; C split into C1 and C2) sharing a patient master index, data dictionary, pathology niche dictionary, imaging quality control, and security framework, but with separate target populations, prediction time points, reference standards, primary endpoints, and sample sizes. Phase I is a retrospective continuous-case cohort for data audit, model development, internal validation, and center/time-window locked external validation. Phase II is an optional prospective non-interventional silent validation after model weights, input specifications, thresholds, and the statistical analysis plan are frozen; model results are not returned to the clinic and care is unchanged. A future clinical-impact trial or RCT is outside this protocol and requires separate ethics approval, consent, and prospective registration before first enrollment. The study never assigns exposure or treatment based on model predictions. A global patient-level split table is built first; patients assigned to external or prospective validation, and all their slides, images, follow-up-derived features, and pathology teacher representations, are excluded from every development fold. Multicenter development uses center- or center-time-window leave-out internal-external cross-validation, retaining at least one fully locked-out center or time cohort.
SUBSTUDIES: A (csPCa) enrolls patients who completed MRI before biopsy or surgery, using MRI plus pre-prediction clinical variables; reference standard tier 1 is whole-gland radical prostatectomy pathology without intervening therapy, tier 2 is qualified MRI-targeted plus systematic biopsy; negative biopsies with inadequate follow-up are not treated as true negatives, and lesion-level analysis is used only when MRI and pathology lesions can be reliably matched. B (pN1) enrolls patients before radical prostatectomy plus pelvic lymph node dissection, using MRI as primary input and PSMA PET/CT as an optional increment; the reference is pathological pN1, with high-confidence pN0 requiring a qualified dissection template, submitted regions, adequate node yield, and complete reporting; low-confidence pN0 are not equi-weighted with pN1. C1 (concurrent M1) uses an index staging image within a +/-90-day pre-treatment window, with PSMA PET/CT as primary input and a blinded multidisciplinary composite reference (pathology, sequential imaging, treatment response, follow-up); the same un-reviewed PSMA report is never the sole gold standard, and initial diagnosis versus recurrent re-staging are stratified. C2 (subsequent metastasis) follows baseline M0 patients from a pre-specified landmark to the first image- or pathology-confirmed distant metastasis, reporting metastasis-free survival, with baseline post-treatment handled as time-dependent and death as a competing event.
DATA AND MEASUREMENTS: Retrospective cases span January 2014 to September 2026 across 28 collaborating centers; prospective silent validation spans October 2026 to October 2029. Data come from electronic medical records, laboratory systems, PACS, pathology information systems, surgical/anesthesia records, cancer registries, death information, and approved follow-up. Cases are selected consecutively, never by outcome. Pathology slides are indexed by patient, specimen, slide, region, and patch; the pathology teacher uses only out-of-fold representations for patients unseen in its training fold. Images retain original DICOM for local QC and are de-identified before entering the research environment; MRI records sequence completeness, slice thickness, b-value, field strength, and vendor, and PSMA PET/CT is structured per PROMISE V2. Reference standards are adjudicated by personnel blinded to model output; difficult concurrent M1 cases are reviewed by an endpoint committee of at least two specialists, with consensus or third-party adjudication.
STATISTICAL ANALYSIS: R 4.4+ and Python 3.11+ are used with frozen dependencies, seeds, and code versions; full analysis, reference-complete, QC-passed, and prospective silent sets are defined separately. Continuous variables are summarized by mean/SD or median/IQR and categorical variables by counts/percentages; missing data use multiple imputation within training folds or in-model handling, with no outcome-informed imputation of predictors in external validation. Development uses pre-trained encoders, regularization, nested cross-validation, bootstrap, and center/time internal-external cross-validation, with out-of-fold pathology teacher outputs; pre-specified clinical-only, imaging-only, pathology-only, direct-supervision, patient-level distillation, and fusion models are compared with niche, modality, and clinical ablations. After freezing, models are validated once per center without re-tuning; discrimination, calibration intercept/slope, fixed-threshold performance, decision curves, abstention, and 95% CIs are reported, with clustered bootstrap for multi-lesion/multi-slide correlation and center-specific and random-effect summaries. Subsequent metastasis uses Cox, flexible parametric, or pre-specified machine-learning survival models, checking proportional hazards, with cumulative incidence and Fine-Gray or cause-specific hazards for competing death and time-dependent AUC, C-index, and dynamic Brier scores. Multiplicity across substudies uses a pre-specified hierarchy or false-discovery-rate control. Sensitivity analyses exclude treated cases, use only high-quality reference standards, stratify by PLND extent/node count, exclude inadequately followed negatives, perform leave-one-center-out validation, restrict to protocol-complete MRI/PET, and vary handling of indeterminate cases.
QUALITY CONTROL AND ETHICS: SOPs cover screening, data dictionary, DICOM/WSI de-identification, QC, reference adjudication, model freezing, analysis, transfer, privacy incidents, and incidental findings, with versioned changes. The retrospective component applies for a waiver of informed consent (but not of ethics review) because it uses existing clinical data and residual specimens without contact or change in care, with de-identification, data minimization, and access control; the prospective silent validation obtains written informed consent. Data are de-identified locally, with encrypted transfer, access approval, logs, and backup; identity mapping tables remain at the source centers. AI outputs are research variables only and are not returned to patients or clinicians; the study is not a patient registry, retains no research biospecimens, and does not share individual participant data.
Men aged 18 years or older evaluated, diagnosed, or followed for suspected or confirmed prostate cancer at 28 collaborating centers across China. The retrospective continuous-case cohort spans January 2014 to September 2026; the optional prospective non-interventional silent validation spans October 2026 to October 2029. A patient may enter one or more nested substudy cohorts, but all data splits are made at the patient level. The entered enrollment is an anticipated pre-screening estimate to be confirmed by center feasibility screening.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who completed MRI before biopsy or surgery; patient- and lesion-level clinically significant prostate cancer (Grade Group 2 or higher) is predicted from MRI and pre-prediction clinical variables, with tiered pathology reference standards.
Patients undergoing radical prostatectomy combined with pelvic lymph node dissection; pathological pN1 is predicted preoperatively, primarily from MRI with PSMA PET/CT as an optional incremental input.
Patients within the +/-90-day pre-treatment baseline staging window; concurrent distant metastasis (M1) is predicted primarily from PSMA PET/CT and confirmed by a blinded multidisciplinary composite reference.
Patients confirmed M0 at baseline who are followed from a pre-specified landmark for the first distant metastasis, with treatment as time-dependent and death as a competing event.
Patient-Level Clinically Significant Prostate Cancer (Grade Group 2 or Higher)
Patient-level presence of clinically significant prostate cancer, defined as histologic ISUP Grade Group 2 or higher, adjudicated against the tiered reference standard (tier 1: whole-gland radical prostatectomy pathology without interval treatment; tier 2: qualified MRI-targeted plus systematic biopsy). Unit of measure: Percentage (%).
Time frame: Periprocedurally, at biopsy or surgery
Pathological Pelvic Lymph Node Metastasis (pN1)
Presence of pathologically confirmed pelvic lymph node metastasis (pN1) after radical prostatectomy with pelvic lymph-node dissection; high-confidence pN0 cases are defined by documented dissection template, submitted regions, and node counts. Unit of measure: Percentage (%).
Time frame: Perioperatively, at radical prostatectomy with pelvic lymph-node dissection
Synchronous Distant Metastasis (M1) at Baseline Staging
Synchronous M1 status within the baseline staging window (within 90 days of the index imaging and before systemic therapy), confirmed by a blinded multidisciplinary composite reference standard. Unit of measure: Percentage (%).
Time frame: Baseline, within 90 days of the index staging imaging
Plan to share: No
Started Jan 2014 (actual). Primary completion is estimated for Oct 2029, 189 months after the start.
Of 540 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 189 months is above that.
Counting every sponsor, half of 649 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
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 Nov 2026. You cannot join it, but the record below documents what was studied.
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Guangxi Medical University