다인종 코호트에서 전립선암 위험 식별: Proclarix의 전향적 미국 다기관 타당성 연구 (PRIME)
다인종 코호트에서 전립선암 위험 식별: 프로클라릭스(Proclarix)에 대한 미국 기반 전향적 다기관 타당성 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Senior Clinical Trial Manager
- 전화번호: 858-202-2000
- 이메일: clinicalaffairsSD@labcorp.com
연구 장소
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California
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San Diego, California, 미국, 92123
- 모병
- Om Research
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연락하다:
- Katie Golshan
- 전화번호: 2668 858-429-7050
- 이메일: kgolshan@omclinicaltrials.com
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연락하다:
- Alanna Gavriushina
- 전화번호: 2668 858-429-7050
- 이메일: alanna.gavriushina@uniohp.com
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수석 연구원:
- Arman Walia, MD
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Idaho
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Meridian, Idaho, 미국, 83642
- 모병
- Idaho Urologic Institute
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연락하다:
- Brian Mihm, LPN
- 전화번호: 208-639-4946
- 이메일: bmihm@idurology.com
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연락하다:
- Karrie Fox, BS
- 전화번호: 208-639-4884
- 이메일: karried@idurology.com
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수석 연구원:
- Joseph Williams, MD
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Kentucky
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Bowling Green, Kentucky, 미국, 42101
- 모병
- Graves Gilbert Clinic
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연락하다:
- Christian Jones
- 전화번호: 716-249-6700
- 이메일: cjones@circuitclinical.com
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연락하다:
- Tanya Atkins
- 전화번호: 716-249-6700
- 이메일: tatkins@circuitclinical.com
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수석 연구원:
- Diego Mastronardi, MD
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Maryland
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Hanover, Maryland, 미국, 21076
- 모병
- Chesapeake Urology Associates
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수석 연구원:
- Kaiser Robertson, MD
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연락하다:
- Barbara Kyei
- 전화번호: 410-760-9400
- 이메일: bkyei@chesuro.com
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Towson, Maryland, 미국, 21204
- 모병
- Chesapeake Urology Associates
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수석 연구원:
- Brian Neuman, MD
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연락하다:
- Tawni Doliveira
- 전화번호: 410-825-5454
- 이메일: tawni.doliveira@chesuro.com
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New York
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Middletown, New York, 미국, 10941
- 모병
- Crystal Run Healthcare
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수석 연구원:
- Steve Rowe, MD
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연락하다:
- Dalea Frank
- 전화번호: 716-249-6700
- 이메일: dfrank@circuitclinical.com
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연락하다:
- Lisa Crespi
- 전화번호: 716-249-6700
- 이메일: lcrespi@circuitclinical.com
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South Carolina
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Myrtle Beach, South Carolina, 미국, 29572
- 모병
- Carolina Urologic Research Center
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연락하다:
- Matt Parton
- 전화번호: 843-839-1679
- 이메일: matthew.parton@startresearch.com
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연락하다:
- Jennifer Smith
- 전화번호: 843-839-1679
- 이메일: jennifer.smith@startresearch.com
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수석 연구원:
- Neil Shore, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.)
기간: 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.
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Neil Shore, MD, Carolina Urologic Research Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- SQNM-PRO-401
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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