Prostatic NeoplasmsNCT04836949
Verification of Shear Wave Elastography for DEtection of Prostate Cancer
A study testing Shear Wave Elastography of prostate and Conventional Prostate Ultrasound in people with Prostatic Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Shear Wave Elastography of prostate and Conventional Prostate Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 May 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA level over 4ng/dl
- Suspicious hard prostatic nodule on digital rectal examination.
- Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
- 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.
- 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.
Read more
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.
- 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.
- 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
- Being tested
- Shear Wave Elastography of prostate, Conventional Prostate Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave Elastography of prostateDevice
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.
Conventional Prostate UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Shear Wave Elastography Group | Experimental | Not described Receives: Device: Shear Wave Elastography of prostate |
| Conventional ultrasonography Group | Active comparator | Not described Receives: Device: Conventional Prostate Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of prostate cancer
The number of subjects diagnosed with prostate cancer and the rate of detection by each group.
Measured: The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start3 May 2021 (estimated)
- Primary completion8 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Woong Kyu Han, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836949
- Sponsor's protocol ID
- 1-2020-0072
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Shear Wave Elastography for DEtection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04836949
- Acronym / sponsor ID
- 1-2020-0072
- Conditions
- Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (estimated)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shear Wave Elastography Group | Experimental | Device: Shear Wave Elastography of prostate |
| Conventional ultrasonography Group | Active comparator | Device: Conventional Prostate Ultrasound |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PSA level over 4ng/dl
- Suspicious hard prostatic nodule on digital rectal examination.
- Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave Elastography of prostateA 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. | Device | Shear Wave Elastography Group |
| Conventional Prostate UltrasoundA 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. | Device | Conventional ultrasonography Group |
Primary outcome
Detection rate of prostate cancer
Time frame: The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.
The number of subjects diagnosed with prostate cancer and the rate of detection by each group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woong Kyu Han principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography of prostate and Conventional Prostate Ultrasound in people with Prostatic Neoplasms, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woong Kyu Han (82-2-2228-2310, hanwk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of prostate cancer (time frame: The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.