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Optimization of the Core Number and Location for Targeted Prostate Biopsy

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MRI/Ultrasound Fusion Saturation Biopsy
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI/Ultrasound Fusion Saturation Biopsy

Arm Description

Outcomes

Primary Outcome Measures

The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area

Secondary Outcome Measures

Full Information

First Posted
July 1, 2021
Last Updated
July 20, 2021
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT04983706
Brief Title
Optimization of the Core Number and Location for Targeted Prostate Biopsy
Official Title
An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI/Ultrasound Fusion Saturation Biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI/Ultrasound Fusion Saturation Biopsy
Intervention Description
MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
Primary Outcome Measure Information:
Title
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
Time Frame
When histology results available, at an expected average of 3 days post-biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqian Guo
Phone
8613605171690
Email
dr.ghq@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qun Lu
Phone
8615195856020
Email
luqun_1989@126.com
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongqian Guo, MD
Phone
8613605171690
Email
dr.ghq@nju.edu.cn
First Name & Middle Initial & Last Name & Degree
Qun Lu, MD
Phone
8615195856020
Email
luqun_1989@126.com

12. IPD Sharing Statement

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Optimization of the Core Number and Location for Targeted Prostate Biopsy

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