Trial reportWorld journal of urology2023
A prospective multi-center randomized comparative trial evaluating outcomes of transrectal ultrasound (TRUS)-guided 12-core systematic biopsy, mpMRI-targeted 12-core biopsy, and artificial intelligence ultrasound of prostate (AIUSP) 6-core targeted biopsy for prostate cancer diagnosis.
Trial report in World journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07631806 (Prospective Validation of an AI-Assisted Multimodal Imaging-Pathology Fusion System for Precision Diagnosis and Biopsy Guidance in Patients With Suspected Prostate Cancer), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Validation of an AI-Assisted Multimodal Imaging-Pathology Fusion System for Precision Diagnosis and Biopsy Guidance in Patients With Suspected Prostate Cancer
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Artificial intelligence in genitourinary oncology: publication trends and systematic review.BJU international · 2026Pooled it
- Concordance of randomised controlled trials for artificial intelligence interventions with the CONSORT-AI reporting guidelines.Nature communications · 2024Pooled it
- Trial
- Current Applications and Future Directions of Artificial Intelligence in Prostate Cancer Diagnosis: A Narrative Review.Current oncology (Toronto, Ont.) · 2026Review
- Primary healthcare-friendly prostate cancer prediction model using routine clinical parameters: a multicenter study.Frontiers in oncology · 2026Article
- European Code Against Cancer, 5th edition - organised cancer screening programmes.Molecular oncology · 2026Review
- Transperineal Free-Hand Prostate Fusion Biopsy with AI-Driven Auto-Contouring: First Results of a Prospective Study.Cancers · 2025Article
- Overdiagnosis and Overtreatment in Prostate Cancer.Diseases (Basel, Switzerland) · 2025Review
- Review
- Concordance with CONSORT-AI guidelines in reporting of randomised controlled trials investigating artificial intelligence in oncology: a systematic review.BMJ oncology · 2025Article
- Enhanced detection of clinically significant prostate cancer in targeted and non-targeted regions using BiopSeeAmerican journal of clinical and experimental urology · 2025Article
- The first-in-human preclinical evaluation of the new probe [123I]I-PSMA-7 for real-time intraoperative targeted biopsy and SPECT/CT imaging in prostate cancer.European journal of nuclear medicine and molecular imaging · 2024Article
- Do we need MRI in all biopsy naïve patients? A multicenter cohort analysis.World journal of urology · 2024Article
- Current Approach to Complications and Difficulties during Transrectal Ultrasound-Guided Prostate Biopsies.Journal of clinical medicine · 2024Review
- [Digitalization in urology-challenge and opportunity].Urologie (Heidelberg, Germany) · 2023Review
- Review
- Review
- The Diagnostic Value of Artificial Intelligence Ultrasound S-Detect Technology for Thyroid Nodules.Computational intelligence and neuroscience · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundArtificial intelligence ultrasound of prostate (AIUSP)-targeted biopsy has been used for prostate cancer (PCa) diagnosis. The objective of this prospective multi-center head-to-head clinical randomized comparative trail (RCT) is to compare PCa detection rate in the TRUS-guided 12-core standard systematic biopsy (TRUS-SB) group and cognitive fused mpMRI-guided 12-core biopsy (mpMRI) group against AIUSP group.
methodsFour hundred patients were randomized to three arms and underwent biopsies by TRUS-SB (n = 133), mpMRI (n = 134), and AIUSP (n = 133) between January 2015 and December 2017. In TRUS-SB group, a standard 12-core systematic biopsy was performed. In mpMRI group, mpMRI-suspicious lesions (PI-RADS 3-5) were targeted by 2-core biopsy followed by a 10-core systematic biopsy. Otherwise, 12-core systematic biopsy was performed. In AIUSP group, a 6-core targeted biopsy was performed. The primary endpoint was PCa detection rate.
resultsAIUSP detected the highest rate of PCa (66/133, 49.6%) compared to TRUS-SB (46/133, 34.6%, p = 0.036) and mpMRI (48/134, 35.8%, p = 0.052). Compared to TRUS-SB (35/133, 26.3%) and mpMRI (31/134, 23.1%) groups, clinically significant PCa (csPCa) detection rate was 32.3% (43/133) in AIUSP group. Overall biopsy core positive rate in the TRUS-SB group (11.0%, 176/1598) and in the mpMRI group (12.7%, 204/1608) was significantly lower than that in the AIUSP group (22.7%, 181/798, p < 0.001).
conclusionsAIUSP detected the highest rate of overall and significant PCa compared to TRUS-SB and mpMRI, and could be used as an alternative to systematic biopsy in the future. REGISTRATION: This trial was registered in ISRCTN (ISRCTN18033113).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.