NCT04836949

Verification of Shear Wave Elastography for DEtection of Prostate Cancer

Status unknown NA Last updated 8 April 2021

What this trial tests

NA trial testing Shear Wave Elastography of prostate in Prostatic Neoplasms in 170 participants. Status unknown.

Timeline

3 May 2021

Primary endpoint
8 December 2023

1 February 2024

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	quadruple
Primary purpose	diagnostic
Enrollment	170
Start date	3 May 2021
Primary completion	8 December 2023
Estimated completion	1 February 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Shear Wave Elastography of prostate
• Conventional Prostate Ultrasound

Conditions studied

• Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Yonsei University

Who can join

Adults 21 to 90, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.