Identificación del Riesgo de Cáncer de Próstata en una Cohorte Multiétnica: un Estudio Prospectivo de Validación Multicéntrico en EE. UU. de Proclarix (PRIME)
Identificación del riesgo de cáncer de próstata en una cohorte multiétnica: un estudio prospectivo de validación multicéntrico basado en EE. UU. de Proclarix
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Senior Clinical Trial Manager
- Número de teléfono: 858-202-2000
- Correo electrónico: clinicalaffairsSD@labcorp.com
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92123
- Reclutamiento
- Om Research
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Contacto:
- Katie Golshan
- Número de teléfono: 2668 858-429-7050
- Correo electrónico: kgolshan@omclinicaltrials.com
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Contacto:
- Alanna Gavriushina
- Número de teléfono: 2668 858-429-7050
- Correo electrónico: alanna.gavriushina@uniohp.com
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Investigador principal:
- Arman Walia, MD
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Idaho
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Meridian, Idaho, Estados Unidos, 83642
- Reclutamiento
- Idaho Urologic Institute
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Contacto:
- Brian Mihm, LPN
- Número de teléfono: 208-639-4946
- Correo electrónico: bmihm@idurology.com
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Contacto:
- Karrie Fox, BS
- Número de teléfono: 208-639-4884
- Correo electrónico: karried@idurology.com
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Investigador principal:
- Joseph Williams, MD
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Kentucky
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Bowling Green, Kentucky, Estados Unidos, 42101
- Reclutamiento
- Graves Gilbert Clinic
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Contacto:
- Christian Jones
- Número de teléfono: 716-249-6700
- Correo electrónico: cjones@circuitclinical.com
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Contacto:
- Tanya Atkins
- Número de teléfono: 716-249-6700
- Correo electrónico: tatkins@circuitclinical.com
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Investigador principal:
- Diego Mastronardi, MD
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Maryland
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Hanover, Maryland, Estados Unidos, 21076
- Reclutamiento
- Chesapeake Urology Associates
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Investigador principal:
- Kaiser Robertson, MD
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Contacto:
- Barbara Kyei
- Número de teléfono: 410-760-9400
- Correo electrónico: bkyei@chesuro.com
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Towson, Maryland, Estados Unidos, 21204
- Reclutamiento
- Chesapeake Urology Associates
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Investigador principal:
- Brian Neuman, MD
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Contacto:
- Tawni Doliveira
- Número de teléfono: 410-825-5454
- Correo electrónico: tawni.doliveira@chesuro.com
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New York
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Middletown, New York, Estados Unidos, 10941
- Reclutamiento
- Crystal Run Healthcare
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Investigador principal:
- Steve Rowe, MD
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Contacto:
- Dalea Frank
- Número de teléfono: 716-249-6700
- Correo electrónico: dfrank@circuitclinical.com
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Contacto:
- Lisa Crespi
- Número de teléfono: 716-249-6700
- Correo electrónico: lcrespi@circuitclinical.com
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South Carolina
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Myrtle Beach, South Carolina, Estados Unidos, 29572
- Reclutamiento
- Carolina Urologic Research Center
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Contacto:
- Matt Parton
- Número de teléfono: 843-839-1679
- Correo electrónico: matthew.parton@startresearch.com
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Contacto:
- Jennifer Smith
- Número de teléfono: 843-839-1679
- Correo electrónico: jennifer.smith@startresearch.com
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Investigador principal:
- Neil Shore, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_ONLY
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.)
Periodo de tiempo: From enrollment to collection of biopsy results at 90 days
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Compare study test results to SOC screening and diagnostic tests. |
From enrollment to collection of biopsy results at 90 days
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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.
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Neil Shore, MD, Carolina Urologic Research Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SQNM-PRO-401
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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