Optimization of the Core Number and Location for Targeted Prostate Biopsy

Nanjing University

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: MRI/Ultrasound Fusion Saturation Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04983706

IUNU-PC-110

Details and patient eligibility

About

This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Full description

This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
4. mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
5. Able to provide written informed consent.

Exclusion criteria

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker);
4. Contraindication to prostate biopsy;
5. Men in whom artifact would reduce the quality of the MRI.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

MRI/Ultrasound Fusion Saturation Biopsy

Experimental group

Treatment:

Procedure: MRI/Ultrasound Fusion Saturation Biopsy