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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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 regime, have resulted in a considerable improvement in the detection of prostate cancer.
1.1.1 Clinical context: Prostate cancer can be present as an indolent low-grade cellular change to the tissue but with very little risk of this progressing to a metastatic life threatening disease. Despite the improved diagnostic capabilities, there remain a significant proportion of men in whom low-grade cancer is detected and consequent treatment options may present a higher risk to quality of life than the presence of the localised disease. Both active surveillance (AS) and watchful waiting (WW) involve proactively monitoring the patient for signs of disease progression rather than undertaking treatment immediately.
The improvements in MRI imaging and reporting indicate that regular scans would add valuable information for patients under AS but capacity is significantly hindering this as an available application.
1.1.2 Technological improvements Emerging technologies in ultrasound imaging, which is less hindered by capacity issues within the UK and is utilised, to a degree, in current standard care, may add another diagnostic tool to monitor disease for patients on AS. A multi-parametric ultrasound assessment may provide the crucial diagnostic features that enables ultrasound imaging to be used to monitor disease. A crucial question remains as to whether the use of additional imaging and health care intervention could improve patient outcomes.
1.1.3 Normalisation Process Theory (NPT) Despite the publication of a defined framework for the development and evaluation of research, there remain substantial problems in the design and conduct of studies introducing complex interventions and their subsequent implementation. If a new technology provides good diagnostic results but is cumbersome and complex to use, it is unlikely to be implemented into routine healthcare practice. A recognised gap exists between developing new treatments and knowledge, and implementing these in practice for the patient who may benefit. An understanding of the ability to implement the proposed new complex ultrasound techniques in real-life clinical practice will be explored within this proof of concept study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •he recruitment criteria and pathway for the clinical phases of the study are outlined in the flow charts, appendix 1 and appendix
- •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
排除标准
- •the recruitment criteria and pathway for the clinical phases of the study are outlined in the flow charts, appendix 1 and appendix
- •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
结局指标
主要结局
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
时间窗: 24-Months from commencement of the study
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.
次要结局
- 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)