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

NCT05840549 | Unknown

• 1 other identifier: CCR5668
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Recruitment rate (number of patients enrolled)

  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

  Number of patients recruited measured at 3 months

• Recruitment rate (number of patients enrolled)

  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

  Number of patients recruited measured at 6 months

• Recruitment rate (number of patients enrolled)

  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

  Number of patients recruited measured at 9 months

• Recruitment rate (number of patients enrolled)

  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

  Number of patients recruited measured at 12 months

• Retention rate

  We will assess the proportion of patients who will complete the trial protocol

  End of study (24 months)

Secondary Outcomes (16)

• Acceptability of intervention

  End of study (24 months)

• Change from baseline in patient reported outcomes as assessed by the Extended Prostate Cancer Index Composite-50 (EPIC-50)

  Baseline, 6 weeks and three months post intervention

• Change from baseline in patient reported outcomes as assessed by the UCLA Prostate Cancer Index (UCLA-PCI)

  Baseline, 6 weeks and three months post intervention

• Change from baseline in patient reported outcomes as assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)

  Baseline, 6 weeks and three months post intervention

• Change from baseline in patient reported outcomes as assessed by the EuroQol EQ-5D

  Baseline, 6 weeks and three months post intervention

Study Arms (2)

TURP

ACTIVE COMPARATOR

Transurethral Resection of Prostate

Procedure: TURP

UroLift

EXPERIMENTAL

UroLift

Procedure: UroLift

Interventions

TURP 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.

TURP

UroLift 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

UroLift

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• King's College London: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• Institute of Cancer Research, United Kingdom: collaborator
• North Cumbria University Hospitals NHS Trust: collaborator
• University College, London: collaborator
• City, University of London: collaborator

Study Sites (3)

St Georges University Hospital

London, Lon, United Kingdom

NOT YET RECRUITING

Kathie Wong

Carlisle, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 37802612 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: May 3, 2023
• Study Start: May 9, 2023
• Primary Completion: May 9, 2024
• Study Completion: May 9, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)