Status:
COMPLETED
Evaluating the Role of Ultrasound in Prostate Cancer
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Collaborating Sponsors:
University of Hull
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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 clin...
Detailed Description
Research Plan 1.1 Purpose and design Across the UK prostate cancer is the most common cancer in men. Developments in magnetic resonance imaging (MRI), and the implementation of a targeted biopsy regim...
Eligibility Criteria
Inclusion
- 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.
- Inclusion criteria for phase 1
- 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
- Inclusion criteria for phase 2
- 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
- Inclusion criteria for phase 3
- 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
Exclusion
- 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.
- Inclusion criteria for phase 1
- 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
- Inclusion criteria for phase 2
- 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
- Inclusion criteria for phase 3
- 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
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05326282
Start Date
December 6 2021
End Date
February 27 2024
Last Update
February 28 2024
Active Locations (1)
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1
Ultrasound, Radiology
Hull, East Yorkshire, United Kingdom, HU16 5JZ