Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-parametric ultrasound | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-parametric and micro ultrasound
- description
- Transrectal ultrasound imaging in men with suspected or known low grade prostate cancer using both standard and micro-ultrasound technology
- interventionNames
- Diagnostic Test: Multi-parametric ultrasound
Primary outcomes (1)
- measure
- The number of identified changes on ultrasound, within the prostate glands of participants, that correlate with changes identified on the gold standard active surveillance imaging
- timeFrame
- 24-Months from commencement of the study
- description
- Ultrasound will be used to image the prostate in patients with suspected and known low grade prostate cancer. The ultrasound images will be compared with the gold standard of prostate MRI, and the histology, from any biopsy undertaken. The ultrasound images will be evaluated to assess for any changes to the appearance of the prostate to understand if prostate disease progression can be detected.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (7)
- BACKGROUNDParker PC, Harrison G. Educating the future sonographic workforce: membership survey report from the British Medical Ultrasound Society. Ultrasound. 2015 Nov;23(4):231-41. doi: 10.1177/1742271X15605344. Epub 2015 Sep 29. PMID 27433263
- RESULTda Silva V, Cagiannos I, Lavallee LT, Mallick R, Witiuk K, Cnossen S, Eastham JA, Fergusson DA, Morash C, Breau RH. An assessment of Prostate Cancer Research International: Active Surveillance (PRIAS) criteria for active surveillance of clinically low-risk prostate cancer patients. Can Urol Assoc J. 2017 Aug;11(8):238-243. doi: 10.5489/cuaj.4093. PMID 28798822
- RESULTde Brun T, O'Reilly-de Brun M, O'Donnell CA, MacFarlane A. Learning from doing: the case for combining normalisation process theory and participatory learning and action research methodology for primary healthcare implementation research. BMC Health Serv Res. 2016 Aug 3;16(a):346. doi: 10.1186/s12913-016-1587-z. PMID 27488361
- RESULTField LJ, Snaith BA. Developing radiographer roles in the context of advanced and consultant practice. J Med Radiat Sci. 2013 Mar;60(1):11-5. doi: 10.1002/jmrs.2. Epub 2013 Feb 5. PMID 26229602
- RESULTFinch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, McColl E, Steen IN, Cook C, Vernazza CR, Mackintosh N, Sharma S, Barbery G, Steele J, Rapley T. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):135. doi: 10.1186/s12874-018-0591-x. PMID 30442094
- RESULTHamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.