Verification of Shear Wave Elastography for DEtection of Prostate Cancer
- 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.
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.
調査の概要
状態
条件
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Woong Kyu Han
- 電話番号：82-2-2228-2310
- メール：hanwk@yuhs.ac
研究場所
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Seoul、大韓民国
- Yonsei University Health System, Severance Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- PSA level over 4ng/dl
- Suspicious hard prostatic nodule on digital rectal examination.
- Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Shear Wave Elastography Group
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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.
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アクティブコンパレータ：Conventional ultrasonography Group
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Detection rate of prostate cancer
時間枠：The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.
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The number of subjects diagnosed with prostate cancer and the rate of detection by each group.
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The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Woong Kyu Han、Severance Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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