Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Hypertrophy

Neoplasm Metastasis

Pathological Conditions, Anatomical

Central Nervous System Depressants

All Drugs and Chemicals

Coagulants

Anesthetics

Anesthetics, Local

Hemostatics

Anesthetics, General

Terephthalic acid

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 (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

Jai Seth

Kathie Wong

Miss Kathie Wong

Mark Brandon-Grove

Professor Nicholas James

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.

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

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

A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement

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

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

The Research Team will carry out 12 in-depth interviews. Using the Theoretical Framework of Acceptability(19), affective attitudes, burden, ethicality, intervention coherence, opportunity costs and perceived effectiveness will be assessed

The EPIC-50 is a validated questionnaire for measuring health related quality of life

The UCLA-PCI is a validated questionnaire for measuring health related quality of life

The ICIQ-UI is a validated questionnaire s a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence

The EQ-5D is a validated questionnaire for measuring health related quality of life

The CICS is a validated questionnaire for assessing illness-related couple communication

The PGI is a validated single item self reported scale to assess patient reported post-operative improvement in condition

The IPSS is a validated questionnaire for measuring the severity of urinary symptoms and overall quality of life

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.

collected and assessed for appropriateness, usability and completeness for both arms 3 months post radiotherapy treatment

30 day surgical morbidity rates will be collected with respect but not limited to infection, urinary retention and bleeding.

Improvement in baseline Urine flowmetry (measured by increased maximum flow rate)

Improvement in baseline Urine flowmetry (measured by post void residual)

Information on costs of the two interventions

Rate of re-operation for technical failure to reduce outflow obstruction

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

Royal Marsden NHS Foundation Trust

Prostatic Hyperplasia

Hyperplasia

Nocturia

Dysuria

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.

Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).

Urolift

Bilal Chughtai, MD

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).

Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy

Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)

Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.

Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.

Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year.

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.

Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.

Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms.

The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.

Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.

Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment

NeoTract, Inc.

Teleflex

Weill Medical College of Cornell University

Genital Neoplasms, Male

Urogenital Neoplasms

Study participants will undergo Urolift System followed by SABR

Stereotactic Body Radiation Therapy for prostate cancer

SABR

Sonobia Garrett, MS

Jose Santoyo

Aurelie Garant, MD

Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)

UroLift System implant will be implanted transurethrally under cystoscopic guidance with a UroLift System Delivery Device by a trained provider. Optimal placement of the implants will be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted but more or less can be placed per provided discretion, up to a maximum of 10 implants per manufacturer specifications.

Given that patients will also undergo UroLift System placement, patients will be offered to undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one single procedure, under general anesthesia.

SAbR will be performed following placement of UroLift System, prostate fiducials, rectal spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema, prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder filling protocol, and appropriate imaging verification.

UroLift System With SAbR for Prostate Cancer and BPH

Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Trial

Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.

AUA, EPIC-26 questionnaires and Noninvasive urodynamics will be obtained, these data will be analyzed once all patients have completed the scheduled trial visits.The aggregate score will be done for (urinary, sexual, bowel, and health-related) associated with UroLift System when administered prior to SABR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement	NCT05840549	Prostate Cancer	TURP UroLift	-	Royal Marsden NHS Foundation Trust
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.	NCT05148156	Benign Prostati...	Urolift	40 Years - 99 Years	Weill Medical College of Cornell University
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement	NCT05840549	Prostate Cancer	TURP UroLift	-	Royal Marsden NHS Foundation Trust
UroLift System With SAbR for Prostate Cancer and BPH	NCT05311527	Prostate Cancer	Urolift SABR	45 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for urolift

Every month we try and update this database with for urolift cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for urolift

Every month we try and update this database with for urolift cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for urolift cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.