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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2025-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial

NCT06362291

Prostate Cancer

COMPLETED NA

Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation

NCT06441292

Prostate Cancer

NOT_YET_RECRUITING NA

Comparison of MRI Artificial Intelligence-guided cTB Versus Routine cTB in Prostate Cancer Diagnosis

NCT06392737

Prostate Cancer

RECRUITING NA

Comparison of Prostate Fusion Biopsies With Software and Cognitive

NCT04291742

Prostate Cancer Detection Fusion Prostate Biopsy

UNKNOWN NA

Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

NCT06517901

Prostate Cancer Diagnosis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cognitive targeted biopsy

a cognitive fusion targeted biopsy combined with a systematic biopsy

Group Type EXPERIMENTAL

cognitive fusion targeted biopsy

Intervention Type PROCEDURE

A cognitive fusion targeted biopsy

software targeted biopsy

software-based fusion targeted biopsy combined with a systematic biopsy

Group Type ACTIVE_COMPARATOR

cognitive fusion targeted biopsy

Intervention Type PROCEDURE

A cognitive fusion targeted biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive fusion targeted biopsy

A cognitive fusion targeted biopsy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes