Evaluating the Role of Ultrasound in Prostate Cancer

NCT05326282 | Completed

• 1 other identifier: R2706
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Prostate Cancer

Keywords

Ultrasound; Micro-ultrasound; Active surveillance

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  24-Months from commencement of the study

Secondary Outcomes (1)

• Change in confidence and knowledge in users of new ultrasound techniques will be measured using a normalization process theory survey completed at baseline and at 12 months following implementation of the study.

  12-months from commencement of this study

Study Arms (1)

Multi-parametric and micro ultrasound

EXPERIMENTAL

Transrectal ultrasound imaging in men with suspected or known low grade prostate cancer using both standard and micro-ultrasound technology

Diagnostic Test: Multi-parametric ultrasound

Interventions

Multi-parametric ultrasound DIAGNOSTIC_TEST

Diagnostic ultrasound parameters used to evaluate the prostate. Transrectal scans will be performed

Also known as: Micro-ultrasound

Multi-parametric and micro ultrasound

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male only as this study is specifically looking at the prostate gland which is absent in females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Ultrasound, Radiology

Hull, East Yorkshire, HU16 5JZ, United Kingdom

Location

Related Publications (7)

• Parker 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 BACKGROUND

• da 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 RESULT

• de 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 RESULT

• Field 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 RESULT

• Finch 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 RESULT

• Hamdy 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.

  PMID: 27626136 RESULT

• Klotz L, Vesprini D, Sethukavalan P, Jethava V, Zhang L, Jain S, Yamamoto T, Mamedov A, Loblaw A. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015 Jan 20;33(3):272-7. doi: 10.1200/JCO.2014.55.1192. Epub 2014 Dec 15.

  PMID: 25512465 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pamela Parker, MSc

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Men with suspected or low grade prostate cancer

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: April 13, 2022
• Study Start: December 6, 2021
• Primary Completion: November 1, 2023
• Study Completion: February 27, 2024
• Last Updated: February 28, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)