多民族コホートにおける前立腺がんリスク同定：Proclarixの米国多施設前向き検証研究 (PRIME)
多民族コホートにおける前立腺癌リスク識別：Proclarixの前向き米国多施設検証研究
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. If a prostate biopsy is performed, it will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores is required if a systematic biopsy is performed. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy.
調査の概要
詳細な説明
Prostate cancer remains a leading cause of cancer-related morbidity and mortality in men worldwide, with significant disparities in incidence and outcomes across different ethnic groups with black men being affected by prostate cancer earlier, more frequently and with more aggressive disease. Current risk stratification tools often lack the precision needed to effectively assess and predict prostate cancer risk in diverse populations.
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant PCa (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥ 2. Proclarix® has been developed and validated on 955 men, in majority of Caucasian background with 90% sensitivity, 43% specificity, 95% negative predictive value (NPV) and 25% positive predictive value (PPV). The validation performance established on German and Austrian patients has been fully confirmed in other European populations: the United Kingdom, Spain, Denmark, Italy and Switzerland.
To be used broadly, confirmation of Proclarix® performance in patients from diverse ethnic backgrounds requires further investigation.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Senior Clinical Trial Manager
- 電話番号：858-202-2000
- メール：clinicalaffairsSD@labcorp.com
研究場所
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California
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San Diego、California、アメリカ、92123
- 募集
- Om Research
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コンタクト：
- Katie Golshan
- 電話番号：2668 858-429-7050
- メール：kgolshan@omclinicaltrials.com
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コンタクト：
- Alanna Gavriushina
- 電話番号：2668 858-429-7050
- メール：alanna.gavriushina@uniohp.com
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主任研究者：
- Arman Walia, MD
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Idaho
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Meridian、Idaho、アメリカ、83642
- 募集
- Idaho Urologic Institute
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コンタクト：
- Brian Mihm, LPN
- 電話番号：208-639-4946
- メール：bmihm@idurology.com
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コンタクト：
- Karrie Fox, BS
- 電話番号：208-639-4884
- メール：karried@idurology.com
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主任研究者：
- Joseph Williams, MD
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Kentucky
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Bowling Green、Kentucky、アメリカ、42101
- 募集
- Graves Gilbert Clinic
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コンタクト：
- Christian Jones
- 電話番号：716-249-6700
- メール：cjones@circuitclinical.com
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コンタクト：
- Tanya Atkins
- 電話番号：716-249-6700
- メール：tatkins@circuitclinical.com
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主任研究者：
- Diego Mastronardi, MD
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Maryland
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Hanover、Maryland、アメリカ、21076
- 募集
- Chesapeake Urology Associates
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主任研究者：
- Kaiser Robertson, MD
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コンタクト：
- Barbara Kyei
- 電話番号：410-760-9400
- メール：bkyei@chesuro.com
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Towson、Maryland、アメリカ、21204
- 募集
- Chesapeake Urology Associates
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主任研究者：
- Brian Neuman, MD
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コンタクト：
- Tawni Doliveira
- 電話番号：410-825-5454
- メール：tawni.doliveira@chesuro.com
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New York
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Middletown、New York、アメリカ、10941
- 募集
- Crystal Run Healthcare
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主任研究者：
- Steve Rowe, MD
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コンタクト：
- Dalea Frank
- 電話番号：716-249-6700
- メール：dfrank@circuitclinical.com
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コンタクト：
- Lisa Crespi
- 電話番号：716-249-6700
- メール：lcrespi@circuitclinical.com
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South Carolina
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Myrtle Beach、South Carolina、アメリカ、29572
- 募集
- Carolina Urologic Research Center
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コンタクト：
- Matt Parton
- 電話番号：843-839-1679
- メール：matthew.parton@startresearch.com
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コンタクト：
- Jennifer Smith
- 電話番号：843-839-1679
- メール：jennifer.smith@startresearch.com
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主任研究者：
- Neil Shore, MD
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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
サンプリング方法
調査対象母集団
Approximately 500 subjects will be enrolled in this study, of which approximately 400 subjects will have a tPSA value of 4-10 ng/mL and 100 subjects will have a tPSA of 2-<4 ng/mL.
説明
Inclusion Criteria:
- Subject is male ≥40 and ≤75 years of age at the time of enrollment;
- Subject provides a signed and dated informed consent;
- Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
- Subject is presenting to the clinic to discuss a potential prostate biopsy;
- Subject agrees to provide all diagnostic test results throughout the study; and
- Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.
7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy.
Exclusion Criteria
- Previous diagnosis of prostate cancer;
- Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
- Acute or chronic urinary tract infection within 3 months of the study blood collection;
- Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
- Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
- Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate within 6 months prior to the study blood collection;
- Subject is not able to read or comprehend the informed consent form;
- Previous enrollment in this protocol with valid biopsy results; or
- Men who had an MRI of the prostate within 90 days prior to the study blood collection.
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
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Prostate cancer suspected
Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy |
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age. |
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 |
|---|---|---|
|
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
時間枠：From enrollment to the collection of prostate biopsy results at 90 days
|
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy. |
From enrollment to the collection of prostate biopsy results at 90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate Proclarix's clinical ability to correlate with and add to the results of other diagnostic tests performed as standard of care (i.e., MRI, ultrasound, etc.)
時間枠：From enrollment to collection of biopsy results at 90 days
|
Compare study test results to SOC screening and diagnostic tests. |
From enrollment to collection of biopsy results at 90 days
|
|
Assess Proclarix®'s clinical performance compared with percent free PSA (%fPSA), the Prostate Health Index (phi), and a risk calculator as proposed by the American Urological Association (AUA) guidelines.
時間枠：From enrollment to collection of biopsy results at 90 days
|
Compare other validated study endpoints to study test results. |
From enrollment to collection of biopsy results at 90 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Neil Shore, MD、Carolina Urologic Research Center
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。