Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy (PROCOG)
Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).
Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.
The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.
A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.
調査の概要
状態
詳細な説明
Prostate cancer is one of the most common malignancies among men. Multiparametric magnetic resonance imaging (mpMRI) has become an important tool for prostate cancer detection and risk stratification, particularly with the use of the Prostate Imaging Reporting and Data System (PI-RADS). Patients with PI-RADS 3-5 lesions are frequently considered candidates for targeted prostate biopsy.
Transrectal ultrasound-guided prostate biopsy has traditionally been the standard biopsy approach. However, the transrectal route may carry a risk of infectious complications due to passage through rectal mucosa and exposure to rectal flora. Transperineal prostate biopsy has gained increasing interest because it avoids transgression of the rectal mucosa and may reduce infectious complications.
Cognitive fusion biopsy is an MRI-targeted biopsy technique in which mpMRI findings are mentally correlated with real-time ultrasound images by the operator. This technique provides an accessible alternative to software-based fusion systems and can achieve accurate targeted sampling when performed by experienced clinicians.
The aim of this study is to prospectively compare transperineal and transrectal cognitive fusion prostate biopsy techniques regarding diagnostic performance and safety outcomes in patients with PI-RADS 3-5 lesions detected on mpMRI.
Eligible participants aged 50-75 years with biopsy indications will be randomized using a computer-generated stratified block randomization method. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 years and ≥60 years).
Participants will undergo either transperineal or transrectal cognitive fusion prostate biopsy according to their assigned study group. Systematic biopsy cores and targeted biopsy cores will be obtained according to the institutional protocol.
The primary endpoint is the detection rate of clinically significant prostate cancer, defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer. The primary analysis will evaluate non-inferiority of transperineal biopsy compared with transrectal biopsy.
Secondary endpoints include overall prostate cancer detection rate, Gleason Grade Group ≥2 cancer detection, infectious complications (fever, urinary infection, prostatitis, sepsis), procedure-related complications (hematuria, hematospermia, urinary retention), pain assessed by visual analog scale (VAS), and procedure duration.
Participants will be followed for 30 days after biopsy for assessment of adverse events and complications.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：MUHAMMED Y AYDIN, Doctor
- 電話番号：+90 +90 554 838 4510
- メール：mysfa63@gmail.com
研究連絡先のバックアップ
- 名前：ALPER G GÖK, PROFESSOR DOCTOR
- 電話番号：+90 532 603 1181
- メール：alper_gok@hotmail.com
研究場所
-
-
Yenimahalle
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Ankara、Yenimahalle、トルコ（Türkiye）、06170
- 募集
- Ankara Etlik City Hospital
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コンタクト：
- ALPER GOK, Proffessor Doctor
- 電話番号：+90 532 603 11 81
- メール：alper_gok@hotmail.com
-
-
参加基準
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
説明
Inclusion Criteria:
- Male patients aged 50-75 years.
- Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).
- Patients with an indication for prostate biopsy.
- Patients who are willing to participate and provide informed consent.
Exclusion Criteria:
- Previous diagnosis of prostate cancer.
- Active urinary tract infection.
- Coagulopathy or bleeding disorders preventing prostate biopsy.
- Absence of multiparametric prostate MRI evaluation.
- No indication for prostate biopsy.
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：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 |
|---|---|
|
アクティブコンパレータ：Transrectal Cognitive Fusion Prostate Biopsy
Participants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.
|
Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
|
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実験的：Transperineal Cognitive Fusion Prostate Biopsy
Participants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol.
|
Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
|
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 |
|---|---|---|
|
Clinically significant prostate cancer detection rate
時間枠：Within 4 weeks after biopsy (after final pathological evaluation)
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Comparison of clinically significant prostate cancer (csPCa) detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques.
Clinically significant prostate cancer is defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer.
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Within 4 weeks after biopsy (after final pathological evaluation)
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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：Within 4 weeks after biopsy (after final pathological evaluation)
|
Comparison of overall prostate cancer detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques
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Within 4 weeks after biopsy (after final pathological evaluation)
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Post-biopsy infectious complications
時間枠：Within 30 days after biopsy
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Assessment and comparison of infectious complications including fever, urinary infection, prostatitis, and sepsis after prostate biopsy.
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Within 30 days after biopsy
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Post-biopsy procedure-related complications
時間枠：Within 30 days after biopsy
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Assessment and comparison of procedure-related complications including hematuria, hematospermia, urethral bleeding, and urinary retention.
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Within 30 days after biopsy
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Pain score after biopsy procedure
時間枠：Immediately after biopsy procedure
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Assessment of patient-reported pain using the Visual Analog Scale (VAS) after biopsy.
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Immediately after biopsy procedure
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Procedure duration
時間枠：During biopsy procedure
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Comparison of procedure duration between transperineal and transrectal cognitive fusion prostate biopsy techniques.
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During biopsy procedure
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- AEŞH-EK-2026-114
- ANKARA ETLIK CITY HOSPİTAL (その他の識別子：ANKARA ETLIK CITY HOSPİTAL)
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?
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
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