Clinical trial NCT05840549: A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
Official title: A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
name: St George's University Hospitals NHS Foundation Trust
name: Institute of Cancer Research, United Kingdom
name: North Cumbria University Hospitals NHS Trust
name: University College, London
name: City, University of London
First posted: 2023-05-03
Enrollment: 45
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: OTHER

Brief 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

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

Primary outcomes:
measure: Recruitment rate (number of patients enrolled)
timeFrame: Number of patients recruited measured at 3 months
measure: Recruitment rate (number of patients enrolled)
timeFrame: Number of patients recruited measured at 6 months
measure: Recruitment rate (number of patients enrolled)
timeFrame: Number of patients recruited measured at 9 months
measure: Recruitment rate (number of patients enrolled)
timeFrame: Number of patients recruited measured at 12 months
measure: Retention rate
timeFrame: End of study (24 months)
Secondary outcomes:
measure: Acceptability of intervention
timeFrame: End of study (24 months)
measure: Change from baseline in patient reported outcomes as assessed by the Extended Prostate Cancer Index Composite-50 (EPIC-50)
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Change from baseline in patient reported outcomes as assessed by the UCLA Prostate Cancer Index (UCLA-PCI)
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Change from baseline in patient reported outcomes as assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Change from baseline in patient reported outcomes as assessed by the EuroQol EQ-5D
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Change from baseline in patient reported outcomes as assessed by the Couples Illness Communication Scale (CICS)
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Change post surgery & post radiotherapy in patient reported outcomes as assessed by the patient global impression of improvement (PGI)
timeFrame: 6 weeks and three months post intervention
measure: Change from baseline in patient reported outcomes as assessed by the International Prostate Symptom Score (IPSS)
timeFrame: Baseline, 6 weeks and three months post intervention
measure: Post treatment functional assessment of cancer therapy prostate (FACT-P)
timeFrame: Three months post intervention
measure: Health related quality of life questionnaires
timeFrame: End of study (24 months)
measure: Safety
timeFrame: 30 days post surgery
measure: Efficacy of procedure
timeFrame: End of study (24 months)
measure: Efficacy of procedure
timeFrame: End of study (24 months)
measure: Efficacy of procedure
timeFrame: End of study (24 months)
measure: Cost of intervention
timeFrame: End of study (24 months)
measure: Re-Operation rate
timeFrame: End of study (24 months)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Georges University Hospital
state: Lon
city: Carlisle
country: United Kingdom
facility: Kathie Wong
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
References: