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NCT05326282Befejeződött

Evaluating the Role of Ultrasound in Prostate Cancer

A Proof of Concept Study Evaluating the Role of Emerging Ultrasound Technologies in the Assessment and Monitoring of Localised Prostate Cancer in Men on an Active Surveillance Programme

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. febr. 28.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Active surveillance (AS) is becoming an increasingly common treatment option for men who have been diagnosed with localised low-grade prostate cancer (PCa). Low-grade disease is commonly noted by clinicians to be clinically insignificant cancer but remains a psychological burden to many men in this cohort. There is consensus that regular review is required for men on AS so that early treatment can be undertaken if there is disease progression, and to support men living with a cancer diagnosis. Some AS protocols, including National Institute for Clinical Excellence (NICE), advocate the use of MRI as a regular part of the monitoring pathway. Unfortunately, access to MRI for AS, within the current health care environment in the UK, is limited due to increasing demand for primary diagnostic examinations, particularly in the post pandemic recovery phase. Emerging technologies in ultrasound imaging may, however, add another diagnostic tool to monitor disease for patients on AS. This proof of concept study is to evaluate whether new multi-parametric ultrasound techniques can safely reduce the number of MRIs required for effective AS. Men being investigated for PCa will be invited to undergo an ultrasound examination of their prostate, via the rectum, in addition to the diagnostic MRI undertaken as part of normal care. The findings of the ultrasound will be directly compared with the MRI and any subsequent biopsy samples taken as part of routine care. Those who then progress onto AS will be invited to undergo regular rectal prostate ultrasound examinations. These will be compared with previous imaging for signs of change. This study will also evaluate the changing role of practitioners who will be using new technologies and making decisions about disease progression. The ability to implement new techniques will be assessed. All imaging will be undertaken at Castle Hill Hospital over a 24-month period from commencement of the study.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
100 (tényleges)
Első benyújtás
2021. szept. 6.
Kezdés
2021. dec. 6.
Elsődleges befejezés
2023. nov. 1.
Fő szponzor
Hull University Teaching Hospitals NHS Trust
Betegségek
Prosztatarák
NCT-szám
NCT05326282

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 100
  • 2021. dec. 6. és az elsődleges befejezés (2023. nov. 1.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Egyéb

  • the recruitment criteria and pathway for the clinical phases of the study are outlined in the flow charts, appendix 1 and appendix 2. These identify when the participants will be invited to participate, when consent will be obtained and the broad outline of the involvement in the study that participants can expect.

Kiket keres a vizsgálat

  • he recruitment criteria and pathway for the clinical phases of the study are outlined in the flow charts, appendix 1 and appendix 2. These identify when the participants will be invited to participate, when consent will be obtained and the broad outline of the involvement in the study that participants can expect.
  • Men referred to urology within Hull University Teaching Hospitals NHS Trust with suspected, but undiagnosed, prostate cancer and:
  • Age equal to 75 or less
  • PSA equal to 20 or less
  • Life expectancy of 10 years or more
  • Multi-parametric MRI performed as part of routine care pathway
  • Are able to tolerate a rectal ultrasound examination
  • Able to provide informed consent to the study
  • Men referred to urology within Hull University Teaching Hospitals NHS Trust with known localised prostate cancer of Gleason 3 + 3 (6) or less and:
  • Are eligible for an AS monitoring pathway
  • Are on an AS monitoring pathway which is regularly reviewed by a consultant urologist
  • Able to attend Castle Hill Hospital for 6 monthly multi-parametric US examinations
  • Are able to tolerate a rectal ultrasound examination
  • Able to provide informed consent to the study
  • Health care practitioner working as a radiologist or sonographer and employed within radiology of Hull University Teaching Hospitals NHS Trust
  • Hold a recognised qualification awarded by the Royal College of Radiologists or a recognised post graduate ultrasound qualification undertaken at a consortium for accreditation of sonographic education (CASE) approved higher education institute
  • Registered with a statutory regulator such as the General Medical Council (GMC), Nursing and Midwifery Council (NMC), Health and Care Professions Council (HCPC)
  • Participates in the current radiology prostate cancer assessment care pathway
  • Able to provide informed consent to the study
  • Men referred to urology within Hull University Teaching Hospitals NHS Trust with suspected, but undiagnosed, prostate cancer and:
  • Age equal to 75 or less
  • PSA equal to 20 or less
  • Life expectancy of 10 years or more
  • Multi-parametric MRI performed as part of routine care pathway
  • Are able to tolerate a rectal ultrasound examination
  • Able to provide informed consent to the study
  • Men referred to urology within Hull University Teaching Hospitals NHS Trust with known localised prostate cancer of Gleason 3 + 3 (6) or less and:
  • Are eligible for an AS monitoring pathway
  • Are on an AS monitoring pathway which is regularly reviewed by a consultant urologist
  • Able to attend Castle Hill Hospital for 6 monthly multi-parametric US examinations
  • Are able to tolerate a rectal ultrasound examination
  • Able to provide informed consent to the study
  • Health care practitioner working as a radiologist or sonographer and employed within radiology of Hull University Teaching Hospitals NHS Trust
  • Hold a recognised qualification awarded by the Royal College of Radiologists or a recognised post graduate ultrasound qualification undertaken at a CASE approved higher education institute
  • Registered with a statutory regulator such as the GMC, NMC or HCPC
  • Participates in the current radiology prostate cancer assessment care pathway
  • Able to provide informed consent to the study

Életkor a regiszterben: 18 év – - · Nem: csak férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Ultrasound, RadiologyHullEgyesült KirályságIsmeretlen állapot

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