A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia

NCT04376008 | Completed

• 1 other identifier: IUNU-PC-104
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.

Conditions

Prostate Neoplasm

Outcome Measures

Primary Outcomes (3)

• Biopsy unfinished rates

  The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy

  1 days

• Pain score

  Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome

  3 days peri-biopsy

• Hospitalization rate due to biopsy

  The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture

  7 days post biopsy

Secondary Outcomes (7)

• Detection rates of clinically significant PCa

  30 days post biopsy

• Detection rates of PCa

  30 days post biopsy

• Biopsy-related complication rates

  30 days post biopsy

• Biopsy time

  1 days

• Consistency rate with final pathology

  30 days post biopsy

Study Arms (2)

PI-RADS 1-2

EXPERIMENTAL

Standard prostate biopsy

Procedure: Standard prostate biopsy

PI-RADS 3-5

EXPERIMENTAL

Targeted and standard prostate biopsy

Procedure: Targeted and standard prostate biopsy

Interventions

Standard prostate biopsy PROCEDURE

Transperineal TRUS guided standard prostate biopsy (SB).

PI-RADS 1-2

Targeted and standard prostate biopsy PROCEDURE

Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).

PI-RADS 3-5

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;
• Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) 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;
• 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, estimated glomerular filtration rate ≤ 50mls/min);
• Contraindication to prostate biopsy.

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

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• 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: May 1, 2020
• First Posted: May 6, 2020
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2022
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CN (1)