A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement

NCT ID: NCT05840549

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2025-05-09

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TURP

Transurethral Resection of Prostate

Group Type: ACTIVE_COMPARATOR

TURP

Intervention Type: PROCEDURE

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.

UroLift

UroLift

Group Type: EXPERIMENTAL

UroLift

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

St George's University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

North Cumbria University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

City, University of London

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Georges University Hospital

London, Lon, United Kingdom

Site Status: NOT_YET_RECRUITING

Kathie Wong

Carlisle, , United Kingdom

Site Status: RECRUITING

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Jai Seth

Role: primary

Kathie Wong

Role: primary

kathie.wong@ncic.nhs.uk

00

Mark Brandon-Grove

Role: primary

Mark.Brandon-Grove@rmh.nhs.uk

02031865416

References

Wong K, Kinsella N, Seth J, Nicol D, Cahill D, Kasivisvanathan R, Withington J, Moghul M, Moss CL, Van Hemelrijck M, Giorgakoudi K, Cottrell C, Yates E, Khoo V, James ND. COmparing Urolift and Standard Transurethral resection of prostate Ahead of Radiotherapy in men with urinary symptoms secondary to prostate enlargement in Southwest London and North Cumbria (CO-STAR): a study protocol for a randomised feasibility study. BMJ Open. 2023 Oct 6;13(10):e076621. doi: 10.1136/bmjopen-2023-076621.

Reference Type: DERIVED

PMID: 37802612 (View on PubMed)

Other Identifiers

CCR5668

Identifier Type: -

Identifier Source: org_study_id