Optimization of the Core Number and Location for Targeted... | NCT04983706

Studies
Optimization of the Core Number and Location for Targeted Prostate Biopsy

NCT04983706

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Status

Unknown status

Last Update Posted

Jul 30, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

MRI/Ultrasound Fusion Saturation Biopsy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2021Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

May 2022Estimated

First Submitted Date

Jul 1, 2021

First Submission Date that Met QC Criteria

Jul 20, 2021

First Posted Date

Jul 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2021

Last Update Posted Date

Jul 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongqian Guo, Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPrincipal Investigator

Lead Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRI/Ultrasound Fusion Saturation Biopsy	Experimental		Procedure: MRI/Ultrasound Fusion Saturation Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongqian Guo	Contact	8613605171690		dr.ghq@nju.edu.cn
Qun Lu	Contact	8615195856020		luqun_1989@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Recruiting	Nanjing	Jiangsu	210000	China

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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