Verification of Shear Wave Elastography for DEtection of Prostate Cancer

NCT04836949 | Unknown

• 1 other identifier: 1-2020-0072
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

• Control group : Patients will undergo prostate biopsy guided by conventional ultrasonography (B mode, gray scale).
• Experimental group : Patients will undergo prostate biopsy guided by shear wave elastography in addition to conventional ultrasonography. A comparative statistical analysis of the two groups will be performed. The study is planned to be conducted for 3 years, with 2 years for patient enrollment and 1 year of follow-up. Three hospitals will participate in the study to enroll 85 patients for each group and a total of 170 patients. 3\. Inclusion and Exclusion criteria
• Male patients with suspected prostate cancer must meet at least one of the following three criteria.
• PSA level over 4ng/dl
• Suspicious hard prostatic nodule on digital rectal examination.
• Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
• Patients who (1) are less than 20 years old, (2) have a history of surgery on the prostate such as HoLEP, (3) have moderate cognitive impairment, or (4) have medical conditions precluding transrectal procedures such as rectal cancer are excluded from the study. 4\. Research method
• Patients who wish to participate in this study and meet the inclusion/exclusion criteria are randomly assigned to the 2 groups as described above.
• The biopsy results are checked one week after the procedure.
• Patients confirmed to have prostate cancer are provided proper treatment according to generally accepted treatment methods.
• Patients with negative biopsy results are followed according to general follow-up protocol for suspected prostate cancer patients. After 6 months from the biopsy the patients are re-evaluated and if cancer is still suspected based on PSA level or other clinical symptoms, prostate MRI or additional biopsy is be performed.
• Patients are followed again after 12 months since the initial biopsy with identical methods from the 6 months follow-up protocol.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Detection rate of prostate cancer

  The number of subjects diagnosed with prostate cancer and the rate of detection by each group.

  The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.

Study Arms (2)

Shear Wave Elastography Group

EXPERIMENTAL

Device: Shear Wave Elastography of prostate

Conventional ultrasonography Group

ACTIVE COMPARATOR

Device: Conventional Prostate Ultrasound

Interventions

Shear Wave Elastography of prostate DEVICE

A 12-core template biopsy is planned as during a conventional prostate biopsy. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. The elasticity of each area is evaluated and region with the maximum Young's modulus value is selected and targeted for biopsy. Additional biopsy for suspicious lesions can be performed at the discretion of the practitioner.

Shear Wave Elastography Group

Conventional Prostate Ultrasound DEVICE

A conventional 12-core template biopsy is planned. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. Random biopsy of each area is performed. Additional biopsy of suspicious hypoechoic nodular lesions can be performed at the discretion of the practitioner.

Conventional ultrasonography Group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Gender Eligibility Details: Male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSA level over 4ng/dl
• Suspicious hard prostatic nodule on digital rectal examination.
• Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.

You may not qualify if:

• Less than 20 years old
• History of surgery on the prostate such as HoLEP
• More than moderate cognitive impairment which limits understanding of the study
• Medical conditions precluding transrectal procedures such as rectal cancer

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

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 Officials

• Woong Kyu Han

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Woong Kyu Han

CONTACT

82-2-2228-2310; hanwk@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 3, 2021
• Primary Completion: December 8, 2023
• Study Completion: February 1, 2024
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)