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

Tongji University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: cognitive fusion targeted biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04271527

CSTB-2019-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 626 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

626 participants in 2 patient groups

cognitive targeted biopsy

Experimental group

Description:

a cognitive fusion targeted biopsy combined with a systematic biopsy

Treatment:

Procedure: cognitive fusion targeted biopsy

software targeted biopsy

Active Comparator group

Description:

software-based fusion targeted biopsy combined with a systematic biopsy

Treatment:

Procedure: cognitive fusion targeted biopsy