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- Other
- Interventional
- Randomized
- Procedure
- Royal Marsden NHS Foundation Trust
- -
Study Purpose
Prostate cancer affects 1 in 8 men and in the UK approximately 14,000 men are treated with radiotherapy. Around half of men diagnosed with prostate cancer will also have an enlarged prostate making it difficult to pass urine. When having radiotherapy, the prostate swells further which can lead to complete blockage of urine flow (urine retention), sepsis and kidney failure in severe cases. Radiotherapy itself can also cause urinary symptoms meaning that some patients can continue to have difficulty passing urine long after their cancer treatment finishes. Around a third of patients will need an operation to shrink their prostate before radiotherapy to prevent these possible short and long-term problems. The standard operation is a transurethral resection of prostate (TURP). This involves cutting a channel through the prostate to improve urine flow. This will be compared with a newer procedure known as UroLift. During UroLift, clips are inserted into the water pipe to pin back the prostate to widen the channel and improve urine flow. Which treatment is more acceptable to patients and gives better outcomes has never been tested before in men having radiotherapy for prostate cancer. The study will help us to understand how the treatments impact on a patient's quality of life and understand what matters most to patients. The results of this feasibility study will help us design a bigger study to assess TURP and UroLift in a larger group of patients across different hospitals. This research will help future patients make decisions about prostate cancer treatment choices that can affect their long-term well-being.
Intervention
Procedure : TURP
Procedure : UroLift
Eligibility Requirements
Men undergoing prostate radiotherapy for prostate cancer
Patients with moderate to severe and/or bothersome lower urinary tract symptoms secondary to prostate enlargement and/or an obstructive flow rate
Patients willing and able to provide written informed consent for the study.
Minimum age: 18
Extensive locally advanced disease
Unfavourable anatomical features (e.g. large middle lobe, for UroLift this requires advanced techniques that have not been fully evaluated in the benign setting(11)
Prostates over 100g (as per manufacturer's guidelines)
Co-morbidities precluding surgical intervention
Prior prostate cancer treatment (including radical prostatectomy, focal therapy i.e. brachytherapy / high intensity focal ultrasound)
Prior surgical intervention for benign prostatic hyperplasia (including prior UroLift / TURP / other prostate de-obstructing procedures)
Urinary symptoms not due to prostatic enlargement as primary cause (i.e. neurological disease)
Patients with complications of prostate enlargement including catheter dependent retention, recurrent urinary tract infections, bladder stones, obstructive uropathy
Urinary incontinence due to an incompetent sphincter
Co-existing gross haematuria
Current active urinary tract infection
Recruiting status
Recruiting
Estimated enrollment
45
Study start date
May 09, 2023
Study end date
May 09, 2025
Last updated
Mar 23, 2025
Primary purpose
Other
Design
Interventional
Intervention
Procedure
Study phase
NA
Allocation
Randomized
Sponsor:
Royal Marsden NHS Foundation Trust
Collaborator:
King's College London
St George's University Hospitals NHS Foundation Trust
Institute of Cancer Research, United Kingdom
North Cumbria University Hospitals NHS Trust
University College, London
City, University of London
Investigator:
N/A
N/A
Publications
N/A
Websites
N/A
NCT05840549
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