Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis (IBIS-PC)
A Prospective, Multicenter, Open-Label, Randomized, Parallel-Group, Noninferiority Trial of MRI/Ultrasound Cognitive Fusion Targeted Biopsy Combined With Ipsilateral Versus Bilateral Systematic Biopsy for Prostate Cancer Diagnosis
Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time, pathological workload, and biopsy-related complications.
This prospective, multicenter, open-label, randomized noninferiority trial will enroll 454 biopsy-naive men with suspected prostate cancer, a unilateral prostate MRI lesion with a highest PI-RADS score of 4 or 5, and prostate-specific antigen levels of 20 ng/mL or lower. Participants will be randomly assigned in a 1:1 ratio to receive transperineal MRI/US cognitive fusion targeted biopsy combined with either a 6-core ipsilateral systematic biopsy or a standard 12-core bilateral systematic biopsy.
The primary objective is to determine whether the ipsilateral systematic biopsy strategy is noninferior to the bilateral systematic biopsy strategy for detecting clinically significant prostate cancer, defined as International Society of Urological Pathology Grade Group 2 or higher. The study will also compare overall prostate cancer detection, biopsy core numbers, pain and discomfort, procedure time, pathological workload and costs, urinary symptoms, quality of life, and biopsy-related adverse events and complications through 30 days after biopsy.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
454
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Haifeng Huang
- 電話番号：+86-186-5165-8099
- メール：24083491@qq.com
研究場所
-
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Jiangsu
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Nanjing、Jiangsu、中国
- 募集
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
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コンタクト：
- Haifeng Huang
- 電話番号：+86-186-5165-8099
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Male participants older than 18 years.
- Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy.
- Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5.
- Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower.
- Able to tolerate and undergo transperineal prostate biopsy.
- Willing to participate in the study and able to provide written informed consent.
Exclusion Criteria:
- Prior prostate biopsy.
- Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery.
- Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher.
- Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy.
- In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：TB+iSB
Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion.
Targeted biopsy will be followed by a 6-core ipsilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on the MRI lesion side.
Local anesthesia will be administered only on the MRI lesion side.
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Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion.
This will be followed by a 6-core systematic biopsy limited to the MRI lesion side, sampling the medial and lateral regions of the base, midgland, and apex.
Local anesthesia will be limited to the MRI lesion side.
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アクティブコンパレータ：TB+SB
Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion.
Targeted biopsy will be followed by a standard 12-core bilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on both sides of the prostate.
Bilateral local anesthesia will be administered.
|
Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion.
This will be followed by a standard 12-core bilateral systematic biopsy sampling the medial and lateral regions of the base, midgland, and apex on both sides of the prostate.
Bilateral local anesthesia will be administered.
|
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 |
|---|---|---|
|
Detection Rate of Clinically Significant Prostate Cancer
時間枠：Day 14 after biopsy
|
The proportion of participants with clinically significant prostate cancer detected by the assigned biopsy strategy.
Clinically significant prostate cancer is defined as biopsy pathology showing International Society of Urological Pathology (ISUP) Grade Group 2 or higher.
The between-group risk difference will be calculated as TB+iSB minus TB+SB.
Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval is greater than -15%.
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Day 14 after biopsy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Prostate Cancer Detection Rate
時間枠：Day 14 after biopsy
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The proportion of participants with prostate cancer detected on any biopsy specimen, regardless of ISUP Grade Group.
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Day 14 after biopsy
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Clinically Insignificant Prostate Cancer Detection Rate
時間枠：Day 14 after biopsy
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The proportion of participants with biopsy pathology showing ISUP Grade Group 1 prostate cancer and no lesion with ISUP Grade Group 2 or higher.
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Day 14 after biopsy
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High-Grade Prostate Cancer Detection Rate
時間枠：Day 14 after biopsy
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The proportion of participants with biopsy pathology showing ISUP Grade Group 3 or higher.
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Day 14 after biopsy
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Pain Numeric Rating Scale Score
時間枠：Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
|
Biopsy-related pain associated with local anesthesia, needle puncture, and biopsy core acquisition will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10.
A score of 0 indicates no pain and a score of 10 indicates the worst imaginable pain.
Higher scores indicate greater pain.
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Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain
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Overall Discomfort Numeric Rating Scale Score
時間枠：Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
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Overall procedural discomfort related to instrument insertion, ultrasound positioning or pressure, prostatic pressure, pelvic floor traction, foreign-body sensation, positioning, and the biopsy procedure will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10.
A score of 0 indicates no discomfort and a score of 10 indicates the worst imaginable discomfort.
Higher scores indicate greater discomfort.
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Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort
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Procedure Time
時間枠：During the biopsy procedure
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Procedure time in minutes, measured from the start of local anesthesia to completion of the final biopsy core.
For the TB+iSB group, timing begins when local anesthesia is started on the MRI lesion side.
For the TB+SB group, timing begins when bilateral local anesthesia is started.
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During the biopsy procedure
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Total Number of Biopsy Cores
時間枠：During the biopsy procedure
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The total number of biopsy cores, including MRI-targeted and systematic biopsy cores, obtained for each participant will be recorded.
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During the biopsy procedure
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Number of Pathology Specimen Containers
時間枠：Periprocedural
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The total number of pathology specimen containers generated from the biopsy procedure will be recorded for each participant.
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Periprocedural
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Total Pathology-Related Costs
時間枠：Up to 2 weeks after biopsy
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Total pathology-related costs associated with biopsy specimen handling, processing, histological examination, and pathology reporting will be obtained from the applicable hospital records for each participant.
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Up to 2 weeks after biopsy
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Incidence of Biopsy-Related Adverse Events and Complications
時間枠：From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
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The proportion of participants experiencing any biopsy-related adverse event or complication will be assessed.
Events include gross hematuria, hematospermia, perineal hematoma, fever or infection, urinary retention, syncope, emergency department visits, unplanned or prolonged hospitalization, serious adverse events, and additional medical interventions required because of a complication.
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From biopsy through 30 days after biopsy; assessed within 30 minutes, at 24 hours, day 7 (±2 days), and day 30 (±7 days)
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Severity of Biopsy-Related Complications by Clavien-Dindo Grade
時間枠：From biopsy through 30 days after biopsy
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The maximum Clavien-Dindo grade of biopsy-related complications will be recorded for each participant.
Grades range from I to V, with higher grades indicating greater severity: Grade I indicates a minor deviation from the expected postoperative course; Grade II requires pharmacological treatment; Grade III requires an intervention; Grade IV indicates a life-threatening complication requiring intensive care; and Grade V indicates death.
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From biopsy through 30 days after biopsy
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Change From Baseline in International Prostate Symptom Score
時間枠：Baseline and 7 days after biopsy (±2 days)
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The International Prostate Symptom Score consists of 7 questions assessing lower urinary tract symptoms.
The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms.
Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
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Baseline and 7 days after biopsy (±2 days)
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Change From Baseline in IPSS Quality of Life Score
時間枠：Baseline and 7 days after biopsy (±2 days)
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The quality of life question associated with the International Prostate Symptom Score ranges from 0 to 6, with higher scores indicating greater dissatisfaction with the participant's urinary condition.
Change from baseline will be calculated as the score at 7 days after biopsy minus the baseline score.
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Baseline and 7 days after biopsy (±2 days)
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Number of Histology Slides
時間枠：Up to 2 weeks after biopsy
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The total number of histology slides generated for biopsy specimen processing and pathological diagnosis will be recorded for each participant.
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Up to 2 weeks after biopsy
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Real-Time Ultrasound Visibility of MRI-Suspicious Lesions
時間枠：During MRI/ultrasound cognitive fusion targeted biopsy
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Each MRI-suspicious lesion designated as L1, L2, or L3 will be classified according to whether it can be identified on real-time ultrasound during MRI/ultrasound cognitive fusion targeted biopsy.
Categories are visible, not visible, uncertain, and not applicable.
The number and proportion of MRI-suspicious lesions in each category will be reported.
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During MRI/ultrasound cognitive fusion targeted biopsy
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ISUP Grade Group Concordance Between Biopsy and Radical Prostatectomy Pathology
時間枠：Up to 6 months after biopsy
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Among participants who undergo radical prostatectomy, the relationship between biopsy ISUP Grade Group and radical prostatectomy ISUP Grade Group will be classified into three mutually exclusive categories: concordant, upgraded, or downgraded.
Concordant is defined as the same ISUP Grade Group on biopsy and radical prostatectomy pathology; upgraded is defined as a higher ISUP Grade Group on radical prostatectomy pathology than on biopsy pathology; and downgraded is defined as a lower ISUP Grade Group on radical prostatectomy pathology than on biopsy pathology.
The number and proportion of participants in each category will be reported.
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Up to 6 months after biopsy
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ここでは、この調査に関係する人々や組織を見つけることができます。
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研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月20日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年8月5日
QC基準を満たした最初の提出物
2026年8月27日
最初の投稿 (実際)
2026年8月31日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月31日
QC基準を満たした最後の更新が送信されました
2026年8月27日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IUNU-PC-131
- 2026-0723-02 (その他の識別子：Medical Ethics Committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
An individual participant data sharing plan has not yet been finalized.
Any future sharing of de-identified participant data will be considered only with approval from the sponsor and the relevant ethics committee and in accordance with applicable laws, regulations, and privacy protection requirements.
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