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Identifiering av prostatacancerrisk i en multietnisk kohort: en prospektiv US-baserad multicenter valideringsstudie av Proclarix (PRIME)

23 september 2026 uppdaterad av: Sequenom, Inc.

Prostatacancer-riskidentifiering i en multietnisk kohort: en prospektiv amerikansk multicenter valideringsstudie av 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • San Diego, California, Förenta staterna, 92123
    • Idaho
      • Meridian, Idaho, Förenta staterna, 83642
        • Rekrytering
        • Idaho Urologic Institute
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Joseph Williams, MD
    • Kentucky
      • Bowling Green, Kentucky, Förenta staterna, 42101
    • Maryland
      • Hanover, Maryland, Förenta staterna, 21076
        • Rekrytering
        • Chesapeake Urology Associates
        • Huvudutredare:
          • Kaiser Robertson, MD
        • Kontakt:
      • Towson, Maryland, Förenta staterna, 21204
        • Rekrytering
        • Chesapeake Urology Associates
        • Huvudutredare:
          • Brian Neuman, MD
        • Kontakt:
    • New York
      • Middletown, New York, Förenta staterna, 10941
    • South Carolina

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;
  2. Subject provides a signed and dated informed consent;
  3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
  4. Subject is presenting to the clinic to discuss a potential prostate biopsy;
  5. Subject agrees to provide all diagnostic test results throughout the study; and
  6. 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

  1. Previous diagnosis of prostate cancer;
  2. Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
  3. Acute or chronic urinary tract infection within 3 months of the study blood collection;
  4. Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
  5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
  6. 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;
  7. Subject is not able to read or comprehend the informed consent form;
  8. Previous enrollment in this protocol with valid biopsy results; or
  9. Men who had an MRI of the prostate within 90 days prior to the study blood collection.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Prostate cancer suspected

Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy
Diagnostiskt test: Proclarix

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.)
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sequenom, Inc.

Samarbetspartners

Labcorp Corporation of America Holdings, Inc

Utredare

  • Huvudutredare: Neil Shore, MD, Carolina Urologic Research Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 april 2026

Primärt slutförande (Beräknad)

31 mars 2027

Avslutad studie (Beräknad)

31 mars 2027

Studieregistreringsdatum

Först inskickad

14 april 2026

Först inskickad som uppfyllde QC-kriterierna

14 april 2026

Första postat (Faktisk)

22 april 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SQNM-PRO-401

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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