Viewing Study NCT04836949



Ignite Creation Date: 2024-05-06 @ 3:59 PM
Last Modification Date: 2024-10-26 @ 2:01 PM
Study NCT ID: NCT04836949
Status: UNKNOWN
Last Update Posted: 2021-04-08
First Post: 2021-04-06

Brief Title: Verification of Shear Wave Elastography for DEtection of Prostate Cancer
Sponsor: Yonsei University
Organization: Yonsei University

Study Overview

Official Title: Verification of Shear Wave Elastography for DEtection of Prostate Cancer
Status: UNKNOWN
Status Verified Date: 2021-04
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 4ngdl
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 inclusionexclusion 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None