Identification du Risque de Cancer de la Prostate dans une Cohorte Multi-Ethnique : une Étude Prospective de Validation Multi-centrique de Proclarix aux États-Unis (PRIME)
Identification du risque de cancer de la prostate dans une cohorte multiethnique : une étude prospective de validation multicentrique américaine 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Senior Clinical Trial Manager
- Numéro de téléphone: 858-202-2000
- E-mail: clinicalaffairsSD@labcorp.com
Lieux d'étude
-
-
California
-
San Diego, California, États-Unis, 92123
- Recrutement
- Om Research
-
Contact:
- Katie Golshan
- Numéro de téléphone: 2668 858-429-7050
- E-mail: kgolshan@omclinicaltrials.com
-
Contact:
- Alanna Gavriushina
- Numéro de téléphone: 2668 858-429-7050
- E-mail: alanna.gavriushina@uniohp.com
-
Chercheur principal:
- Arman Walia, MD
-
-
Idaho
-
Meridian, Idaho, États-Unis, 83642
- Recrutement
- Idaho Urologic Institute
-
Contact:
- Brian Mihm, LPN
- Numéro de téléphone: 208-639-4946
- E-mail: bmihm@idurology.com
-
Contact:
- Karrie Fox, BS
- Numéro de téléphone: 208-639-4884
- E-mail: karried@idurology.com
-
Chercheur principal:
- Joseph Williams, MD
-
-
Kentucky
-
Bowling Green, Kentucky, États-Unis, 42101
- Recrutement
- Graves Gilbert Clinic
-
Contact:
- Christian Jones
- Numéro de téléphone: 716-249-6700
- E-mail: cjones@circuitclinical.com
-
Contact:
- Tanya Atkins
- Numéro de téléphone: 716-249-6700
- E-mail: tatkins@circuitclinical.com
-
Chercheur principal:
- Diego Mastronardi, MD
-
-
Maryland
-
Hanover, Maryland, États-Unis, 21076
- Recrutement
- Chesapeake Urology Associates
-
Chercheur principal:
- Kaiser Robertson, MD
-
Contact:
- Barbara Kyei
- Numéro de téléphone: 410-760-9400
- E-mail: bkyei@chesuro.com
-
Towson, Maryland, États-Unis, 21204
- Recrutement
- Chesapeake Urology Associates
-
Chercheur principal:
- Brian Neuman, MD
-
Contact:
- Tawni Doliveira
- Numéro de téléphone: 410-825-5454
- E-mail: tawni.doliveira@chesuro.com
-
-
New York
-
Middletown, New York, États-Unis, 10941
- Recrutement
- Crystal Run Healthcare
-
Chercheur principal:
- Steve Rowe, MD
-
Contact:
- Dalea Frank
- Numéro de téléphone: 716-249-6700
- E-mail: dfrank@circuitclinical.com
-
Contact:
- Lisa Crespi
- Numéro de téléphone: 716-249-6700
- E-mail: lcrespi@circuitclinical.com
-
-
South Carolina
-
Myrtle Beach, South Carolina, États-Unis, 29572
- Recrutement
- Carolina Urologic Research Center
-
Contact:
- Matt Parton
- Numéro de téléphone: 843-839-1679
- E-mail: matthew.parton@startresearch.com
-
Contact:
- Jennifer Smith
- Numéro de téléphone: 843-839-1679
- E-mail: jennifer.smith@startresearch.com
-
Chercheur principal:
- Neil Shore, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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.)
Délai: 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.
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Neil Shore, MD, Carolina Urologic Research Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SQNM-PRO-401
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .