Comparing UroLift and TURP for men with urinary issues before prostate cancer radiotherapy
A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
This study is testing whether UroLift or TURP is better at relieving urinary problems in men with prostate enlargement before they start radiotherapy for prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Sex | Male |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 3 sites (London, Lon and 2 other locations) |
| Trial ID | NCT05840549 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two procedures, UroLift and transurethral resection of the prostate (TURP), in treating urinary symptoms caused by prostate enlargement in men undergoing radiotherapy for prostate cancer. The research focuses on men who experience lower urinary tract symptoms due to bladder outflow obstruction, which can worsen during radiotherapy. By addressing these urinary issues before treatment, the study seeks to prevent complications such as urinary retention and kidney failure. Participants will be monitored for outcomes related to urinary function and overall treatment success.
Who should consider this trial
Good fit: Ideal candidates are men with prostate cancer who are scheduled for radiotherapy and have moderate to severe urinary symptoms due to prostate enlargement.
Not a fit: Patients with extensive locally advanced prostate cancer or those who have had prior surgical interventions for prostate issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective approach to managing urinary symptoms in men undergoing prostate cancer treatment.
How similar studies have performed: Previous studies have shown success with UroLift in treating benign prostatic hyperplasia, but its application in this specific context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
London, Lon and 2 other locations
- St Georges University Hospital — London, Lon, United Kingdom (Not_yet_recruiting)
- Kathie Wong — Carlisle, United Kingdom (Recruiting)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.