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Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation (PERSONAL)

26. februar 2019 opdateret af: The Leeds Teaching Hospitals NHS Trust

One in 8 men will be diagnosed with prostate cancer during their lifetime. The majority of men diagnosed with prostate cancer have early stage disease, which can be managed in a variety of ways, ranging from monitoring to international treatment. However is it not always clear which treatment option is best.

All men with newly diagnosed localised prostate cancer are assigned a disease risk category (low/intermediate/high risk). This is based on clinical findings and prostate biopsy results, but these factors are limited in their ability to distinguish between aggressive and indolent prostate cancers. The current risk grouping can make it difficult to plan appropriate treatment tailored and personalised to the individual patient.

There is evidence reporting overtreatment of localised prostate cancer in the UK. However, many patients with aggressive disease are wrongly assigned a low risk categorisation and are recommended surveillance when better suited to more interventional treatment.

Myriad Genetics have developed a test, called Prolaris which measures how fast cells in a prostate cancer are dividing to assess its aggressiveness. The Prolaris test is performed on routine prostate biopsy tissue, so patients are not subjected to any additional invasive investigations.

In this study, led by Leeds Teaching Hospitals NHS Trust, the aim is find out if the Prolaris® test score helps patients with newly diagnosed prostate cancer and their clinical team make better informed treatment choices that are tailored to the individual patient.

The aim to achieve a Prolaris risk score for 100 patients and determine the impact it has on treatment decision making. The research team will look at how the test fits into routine clinical practice, investigate the clinician and patient views and understanding on the test report and assess the quality of life of patients in the different risk and treatment groups.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • West Yorkshire
      • Leeds, West Yorkshire, Det Forenede Kongerige, LS9 7TF
        • Rekruttering
        • St James's University Hospitals NHS Trust
        • Kontakt:
          • William Cross, MRCS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Men who have a diagnosis of prostate cancer on their prostate biopsy.

Beskrivelse

Inclusion Criteria:

  • Clinical suspicion of prostate cancer
  • Able to provide informed written consent
  • No contraindication to prostate biopsy
  • Newly diagnosed treatment-naive patient with histologically proven localised adenocarcinoma of the prostate
  • Low or intermediate D'Amico risk prostate cancer
  • Sufficient quantity and quality of tissue remains from biopsy to perform genomic testing
  • No contraindication to radical treatment if diagnosed with localised prostate cancer
  • Estimated life expectancy >10 years

Exclusion Criteria:

  • Men with locally advanced, clinical node positive or metastatic disease
  • Patients who lack capacity to consent to study participation
  • Non-adenocarcinoma prostate cancer histology

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prolaris test outcome received via report.
Tidsramme: 30-60mins
Results of the test received.
30-60mins
Treatment counselling
Tidsramme: 30-60mins
Feedback of the results of the prolaris test. Consultant Urologist will see each participant in clinic after receipt of the Prolaris test report. They will explain the results to the patient and the patient will have the opportunity to ask any questions that they may have. The patient will then be able to decide on their treatment option.
30-60mins

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. februar 2019

Primær færdiggørelse (Forventet)

30. oktober 2020

Studieafslutning (Forventet)

30. oktober 2020

Datoer for studieregistrering

Først indsendt

21. februar 2019

Først indsendt, der opfyldte QC-kriterier

21. februar 2019

Først opslået (Faktiske)

22. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UR17/104867

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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