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Recruiting NCT04271527

Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive fusion targeted biopsy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Non-inferiority Randomized Controlled Trial of Cognitive Fusion Targeted Biopsy Versus Software-based Fusion Targeted Biopsy

Overview

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.

Detailed description

This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.

Interventions

  • Procedure cognitive fusion targeted biopsy
    A cognitive fusion targeted biopsy

Primary outcome measures

  • The detection rate of clinically significant prostate cancer for targeted biopsy [Time frame: 5-6 weeks after signing the consent]
Secondary outcome measures (10)
  • The detection rate of any prostate cancer for targeted biopsy [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer for combined biopsy [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of any prostate cancer for combined biopsy [Time frame: 5-6 weeks after signing the consent]
  • Prostate volume [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3 [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4 [Time frame: 5-6 weeks after signing the consent]
  • The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5 [Time frame: 5-6 weeks after signing the consent]

Eligibility criteria

Inclusion criteria

  • Age > 18
  • PSA increase to 4-20 ng/ml and/or abnormal DRE;
  • Sign the informed consent

Exclusion criteria

  • Have acute or chronic prostatitis
  • Contraindications to prostate biopsy
  • Contraindications to MRI
  • Other reasons that not suitable for this trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Shanghai East Hospital, Tongji University School of Medicine — Shanghai

Publications

  • He 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 J PMID 42431755
  • He 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/ PMID 33550242

Identifiers

NCT: NCT04271527 · CSTB-2019-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗