Clinical trial · Interventional
Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy
NCT04271527CI-TRIAL-00079870unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive fusion targeted biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cognitive targeted biopsy
- description
- a cognitive fusion targeted biopsy combined with a systematic biopsy
- interventionNames
- Procedure: cognitive fusion targeted biopsy
- type
- ACTIVE_COMPARATOR
- label
- software targeted biopsy
- description
- software-based fusion targeted biopsy combined with a systematic biopsy
- interventionNames
- Procedure: cognitive fusion targeted biopsy
Primary outcomes (1)
- measure
- The detection rate of clinically significant prostate cancer for targeted biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 2. PSA increase to 4-20 ng/ml and/or abnormal DRE; 3. Sign the informed consent Exclusion Criteria: 1. Have acute or chronic prostatitis 2. Contraindications to prostate biopsy 3. Contraindications to MRI 4. Other reasons that not suitable for this trial
References
Publications (2)
- DERIVEDHe BM, Zhang K, Zhou Z, Chen X, Liu Y, Dong B, Wang Y, Xing Y, He W, Jin Z, Zhang T, Feng T, Liang L, Chen B, Chen S, Lu Z, Zhou S, Zhao Y, Liu Y, Wang Z, Na R, Zhang X, Shi B, Wang HF; IMAGINATION Group. Cognitive Versus Software-based Fusion Targeted Biopsy for the Diagnosis of Clinically Significant Prostate Cancer: A Multicenter, Randomized, Noninferiority Trial (IMAGINATION). Eur Urol. 2026 Jul 10:S0302-2838(26)02243-8. doi: 10.1016/j.eururo.2026.06.020. Online ahead of print. PMID 42431755
- DERIVEDHe B, Li R, Li D, Huang L, Wen X, Yang G, Wang H. Study protocol for a single-centre non-inferior randomised controlled trial on a novel three-dimensional matrix positioning-based cognitive fusion-targeted biopsy and software-based fusion-targeted biopsy for the detection rate of clinically significant prostate cancer in men without a prior biopsy. BMJ Open. 2021 Feb 5;11(2):e041427. doi: 10.1136/bmjopen-2020-041427. PMID 33550242