NCT05326282Completed

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2024

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Interventional
Enrollment: 100 (actual)
First submitted: 6 Sept 2021
Start date: 6 Dec 2021
Primary completion date: 1 Nov 2023
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Diseases: Prostate cancer
NCT number: NCT05326282

What you commit to

Study type: Interventional
Participants enrolled: 100
From 6 Dec 2021 to the primary completion date, 1 Nov 2023
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Ultrasound, Radiology Coordinator of this site? Confirm its status	Hull	United Kingdom	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.