Trial Title:
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
NCT ID:
NCT05840549
Condition:
Prostate Cancer
Conditions: Official terms:
Hypertrophy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomised controlled trial
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TURP
Description:
TURP is an operation which can be performed under a general / regional anaesthetic. A
cystoscope is passed into the urethra meatus, along the length of the urethra to the
level of the prostate. The obstructing prostate lobes are resected using mono polar or
bipolar energy to create a channel for improved urinary flow. Haemostasis is achieved by
coagulation followed by insertion of a catheter for irrigation post procedure. Generally,
patients stay for 1-2 nights post operatively. On the day of discharge the catheter is
removed.
Arm group label:
TURP
Intervention type:
Procedure
Intervention name:
UroLift
Description:
UroLift (Neotract) is a NICE-approved alternative to TURP that can be performed under
local anaesthetic, sedation or general anaesthetic. The system comprises of two
single-use components, a delivery device and an implant. The implant is made of a nitinol
capsular tab, a polyethylene terephthalate monofilament and a stainless-steel end-piece.
Again, a modified cystoscope is passed into the urethral meatus, along the length of the
urethra to the level of the prostate. The delivery device deploys the implants into the
prostate to 'pin' back the lobes of the prostate to create a channel for improved flow.
Typically, 2-4 implants are used per procedure. Nine out of ten patients do not require a
catheter post procedure
Arm group label:
UroLift
Summary:
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.
Detailed description:
Prostate radiotherapy can cause lower urinary tract symptoms (LUTS) such as urinary
frequency, difficulty starting a urine stream or feelings of incomplete emptying. 50% of
men aged over 60 years may have pre-existing LUTS from bladder outflow obstruction (BOO)
due to prostatic enlargement.
The short-term complications of untreated BOO in the context of prostate radiotherapy,
although relatively rare, can be disastrous, leading to urinary retention, sepsis and
renal failure. In the long-term, urinary symptoms and complications can continue to
worsen. Patients with low flow rates pre-radiotherapy are at highest risk of urinary
retention and are often offered transurethral resection of prostate (TURP) prior to
radiotherapy. An urgent transurethral resection of prostate (TURP) either during or post
radiotherapy may significantly disrupt the completion of the treatment and compromise
outcomes, both oncological and functional. Case studies suggest that when patients
undergo a TURP to treat prostate enlargement after radiotherapy, the risk of incontinence
is much higher than surgery before radiotherapy. Therefore, for radiotherapy to safely go
ahead, BOO due to an enlarged prostate must first be addressed. UroLift is a newer,
minimally invasive alternative to TURP, approved by NICE for use in BPH and available in
over 100 trusts nationally. A growing body of evidence including three meta-analyses
supports its use in benign disease.
UroLift has not been trialled in patients undergoing prostate radiotherapy with
coexisting LUTS. A subgroup analysis performed on retrospective data suggested that
patients who had previously undergone prostate radiotherapy experienced symptom relief
without an increase in adverse events.
The purpose of this trial is to produce a protocol for a randomised controlled evaluation
of clinical and cost effectiveness of UroLift in comparison to TURP for men due to
receive radiotherapy as treatment for prostate cancer. At the end of this study, we will
understand whether such a trial is acceptable to all stakeholders, is methodologically
robust and thus feasible. Furthermore, we will be able to report pilot findings for
safety and efficacy
Criteria for eligibility:
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
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St Georges University Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Jai Seth
Investigator:
Last name:
Jai Seth
Email:
Principal Investigator
Facility:
Name:
Kathie Wong
Address:
City:
Carlisle
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kathie Wong
Phone:
00
Email:
kathie.wong@ncic.nhs.uk
Investigator:
Last name:
Miss Kathie Wong
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mark Brandon-Grove
Phone:
02031865416
Email:
Mark.Brandon-Grove@rmh.nhs.uk
Investigator:
Last name:
Professor Nicholas James
Email:
Principal Investigator
Start date:
May 9, 2023
Completion date:
May 9, 2025
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
King's College London
Agency class:
Other
Collaborator:
Agency:
St George's University Hospitals NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
North Cumbria University Hospitals NHS Trust
Agency class:
Other
Collaborator:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
City, University of London
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840549
