CO-STAR: A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TURP Transurethral Resection of Prostate |
Procedure: TURP
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.
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| Experimental: UroLift UroLift |
Procedure: UroLift
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
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Outcome Measures
Primary Outcome Measures
- Recruitment rate (number of patients enrolled) [Number of patients recruited measured at 3 months]
We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena
- Recruitment rate (number of patients enrolled) [Number of patients recruited measured at 6 months]
We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena
- Recruitment rate (number of patients enrolled) [Number of patients recruited measured at 9 months]
We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena
- Recruitment rate (number of patients enrolled) [Number of patients recruited measured at 12 months]
We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena
- Retention rate [End of study (24 months)]
We will assess the proportion of patients who will complete the trial protocol
Secondary Outcome Measures
- Safety (AE's and SAE's) [End of study (24 months)]
Is the UroLift procedure safe and comparable to TURP
- Acceptability of intervention [End of study (24 months)]
Determination of patient acceptability of the proposed interventions and patient reported outcomes measures
- Cost of intervention [End of study (24 months)]
Information on costs of the two interventions
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men undergoing prostate radiotherapy for prostate cancer
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Patients with moderate to severe and/or bothersome lower urinary tract symptoms secondary to prostate enlargement and/or an obstructive flow rate
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Patients willing and able to provide written informed consent for the study.
Exclusion Criteria:
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Extensive locally advanced disease
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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)
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Prostates over 100g (as per manufacturer's guidelines)
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Co-morbidities precluding surgical intervention
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Prior prostate cancer treatment (including radical prostatectomy, focal therapy i.e. brachytherapy / high intensity focal ultrasound)
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Prior surgical intervention for benign prostatic hyperplasia (including prior UroLift / TURP / other prostate de-obstructing procedures)
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Urinary symptoms not due to prostatic enlargement as primary cause (i.e. neurological disease)
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Patients with complications of prostate enlargement including catheter dependent retention, recurrent urinary tract infections, bladder stones, obstructive uropathy
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Urinary incontinence due to an incompetent sphincter
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Co-existing gross haematuria
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Current active urinary tract infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Georges University Hospital | London | Lon | United Kingdom | |
| 2 | Kathie Wong | Carlisle | United Kingdom | ||
| 3 | The Royal Marsden NHS Foundation Trust | London | United Kingdom | SW3 6JJ |
Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCR5668