Optimization of the Core Number and Location for Targeted Prostate Biopsy

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: MRI/Ultrasound Fusion Saturation Biopsy

• Registration Number: NCT04983706
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-01
• Study Start: 2021-07-05
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-30
• Last Update Posted: 2021-07-30
• Primary Completion: 2021-11
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI/Ultrasound Fusion Saturation Biopsy	MRI/Ultrasound Fusion Saturation Biopsy	-

Primary Outcome Measures

Name	Time	Method
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area	When histology results available, at an expected average of 3 days post-biopsy

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China