Optimization of the Core Number and Location for Targeted Prostate Biopsy

NCT04983706 | Unknown

• 1 other identifier: IUNU-PC-110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI/Ultrasound Fusion Saturation Biopsy

EXPERIMENTAL

Procedure: MRI/Ultrasound Fusion Saturation Biopsy

Interventions

MRI/Ultrasound Fusion Saturation Biopsy PROCEDURE

MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.

MRI/Ultrasound Fusion Saturation Biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Hongqian Guo

CONTACT

8613605171690; dr.ghq@nju.edu.cn

Qun Lu

CONTACT

8615195856020; luqun_1989@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 30, 2021
• Study Start: July 5, 2021
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

CN (1)