Verification of Shear Wave Elastography for DEtection of Prostate Cancer

1. Objective To provide evidence that adding shear wave elastography during sono-guided prostate biopsy can increase prostate cancer detection rate and to demonstrate that shear wave elastography of the prostate can discriminate malignant lesions to reduce the number of unnecessary prostate biopsies.

2. Overview Patients who are indicated for prostate biopsy in suspicion of prostate cancer will be assigned to a control group and an intervention group under double blinded randomization.

   • 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.

  1. PSA level over 4ng/dl
  2. Suspicious hard prostatic nodule on digital rectal examination.
  3. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Device: Shear Wave Elastography of prostate; Device: Conventional Prostate Ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woong Kyu Han; Phone Number: 82-2-2228-2310; Email: hanwk@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shear Wave Elastography Group	Device: Shear Wave Elastography of prostate; 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.
Active Comparator: Conventional ultrasonography Group	Device: Conventional Prostate Ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Woong Kyu Han, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 3, 2021
• Primary Completion (Anticipated): December 8, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 1-2020-0072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No