Prostate CancerCO-STARNCT05840549
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement
A study testing TURP and UroLift in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TURP and UroLift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 May 2023to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Kathie Wong
Carlisle
Kathie Wong, 00, kathie.wong@ncic.nhs.uk
Miss Kathie Wong
- Not yet recruiting
St Georges University Hospital
London, Lon
Jai Seth
Jai Seth
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
Mark Brandon-Grove, 02031865416, Mark.Brandon-Grove@rmh.nhs.uk
Professor Nicholas James
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- TURP, UroLift
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
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.
UroLiftProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| TURP | Active comparator | Transurethral Resection of Prostate Receives: Procedure: TURP |
| UroLift | Experimental | UroLift Receives: Procedure: UroLift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Number of patients recruited measured at 12 months
Retention rate
We will assess the proportion of patients who will complete the trial protocol
Measured: End of study (24 months)
Secondary outcomes (16)
Acceptability of intervention
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
Measured: End of study (24 months)
Change from baseline in patient reported outcomes as assessed by the Extended Prostate Cancer Index Composite-50 (EPIC-50)
The EPIC-50 is a validated questionnaire for measuring health related quality of life
Measured: 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)
The UCLA-PCI is a validated questionnaire for measuring health related quality of life
Measured: 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)
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
Measured: Baseline, 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the EuroQol EQ-5D
The EQ-5D is a validated questionnaire for measuring health related quality of life
Measured: Baseline, 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the Couples Illness Communication Scale (CICS)
The CICS is a validated questionnaire for assessing illness-related couple communication
Measured: Baseline, 6 weeks and three months post intervention
Change post surgery & post radiotherapy in patient reported outcomes as assessed by the patient global impression of improvement (PGI)
The PGI is a validated single item self reported scale to assess patient reported post-operative improvement in condition
Measured: 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the International Prostate Symptom Score (IPSS)
The IPSS is a validated questionnaire for measuring the severity of urinary symptoms and overall quality of life
Measured: Baseline, 6 weeks and three months post intervention
Post treatment functional assessment of cancer therapy prostate (FACT-P)
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.
Measured: Three months post intervention
Health related quality of life questionnaires
collected and assessed for appropriateness, usability and completeness for both arms 3 months post radiotherapy treatment
Measured: End of study (24 months)
Safety
30 day surgical morbidity rates will be collected with respect but not limited to infection, urinary retention and bleeding.
Measured: 30 days post surgery
Efficacy of procedure
Improvement in baseline IPSS score
Measured: End of study (24 months)
Efficacy of procedure
Improvement in baseline Urine flowmetry (measured by increased maximum flow rate)
Measured: End of study (24 months)
Efficacy of procedure
Improvement in baseline Urine flowmetry (measured by post void residual)
Measured: End of study (24 months)
Cost of intervention
Information on costs of the two interventions
Measured: End of study (24 months)
Re-Operation rate
Rate of re-operation for technical failure to reduce outflow obstruction
Measured: End of study (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start9 May 2023
- Primary completion9 May 2024 (estimated)
- Study completion9 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840549
- Sponsor's protocol ID
- CCR5668
- Acronym
- CO-STAR
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37802612
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05840549
- Acronym / sponsor ID
- CO-STAR / CCR5668
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- 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
- Study start
- 9 May 2023 (actual)
- Primary completion
- 9 May 2024 (estimated)
- Study completion
- 9 May 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| TURP | Active comparator | Procedure: TURPTransurethral Resection of Prostate |
| UroLift | Experimental | Procedure: UroLiftUroLift |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TURPTURP 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. | Procedure or surgery | TURP |
| UroLiftUroLift (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 | Procedure or surgery | UroLift |
Primary outcome
Recruitment rate (number of patients enrolled)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: End of study (24 months)
We will assess the proportion of patients who will complete the trial protocol
16 secondary outcomes
Acceptability of intervention
Time frame: End of study (24 months)
Change from baseline in patient reported outcomes as assessed by the Extended Prostate Cancer Index Composite-50 (EPIC-50)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the EuroQol EQ-5D
Time frame: Baseline, 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the Couples Illness Communication Scale (CICS)
Time frame: Baseline, 6 weeks and three months post intervention
Change post surgery & post radiotherapy in patient reported outcomes as assessed by the patient global impression of improvement (PGI)
Time frame: 6 weeks and three months post intervention
Change from baseline in patient reported outcomes as assessed by the International Prostate Symptom Score (IPSS)
Time frame: Baseline, 6 weeks and three months post intervention
Post treatment functional assessment of cancer therapy prostate (FACT-P)
Time frame: Three months post intervention
Health related quality of life questionnaires
Time frame: End of study (24 months)
Safety
Time frame: 30 days post surgery
Efficacy of procedure
Time frame: End of study (24 months)
Efficacy of procedure
Time frame: End of study (24 months)
Efficacy of procedure
Time frame: End of study (24 months)
Cost of intervention
Time frame: End of study (24 months)
Re-Operation rate
Time frame: End of study (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 37802612Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Royal Marsden NHS Foundation Trust
London, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURP and UroLift in people with Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (number of patients enrolled) (time frame: Number of patients recruited measured at 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.