Benign Prostatic Hyperplasia (BPH)NCT03817216

Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer

A study testing Prostatic Urethral Lift (PUL) in people with Benign Prostatic Hyperplasia (BPH) and Prostate Cancer, run by Case Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms. Read more about this study

Who is it for?: Ages 51 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH), Prostate Cancer
What is being tested?: Prostatic Urethral Lift (PUL)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Dec 2019to 30 Mar 2023
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 51 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

International Prostate Symptom Score ≥ 12.
Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).

Who cannot join

Obstructive median lobe of the prostate.
Active urinary tract infection.
Neurogenic non-obstructive voiding dysfunction.
Obstructive symptoms secondary to prostate cancer (via cystoscopy).
Patients with prior Transurethral resection of the prostate (TURP).
Patients with prior history of urethral stricture.

About this study

Official title: Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms

Read the detailed description

Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy. The primary objective of this study is to achieve urinary obstructive symptom relief in prostate cancer participants undergoing radiotherapy treatment with placement of PUL. This will be quantified using primary effectiveness endpoints:

For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy (BT) from pre-PUL baseline.

The team will also assess participant outcomes with regard to International Prostate Symptom Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores, Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External Beam Radiotherapy (EBRT), post-BT, and pre-BT.

Conditions: Benign Prostatic Hyperplasia (BPH), Prostate Cancer
Being tested: Prostatic Urethral Lift (PUL)
Keywords: Prostatic Urethral Lift (PUL)
Medical subject headings: Prostatic Hyperplasia, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prostatic Urethral Lift (PUL)Device
PUL/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH). This study evaluates UroLift's efficacy participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy.

Study groups in NCT03817216
Study group	Role	What they receive
Prostatic Urethral Lift (PUL) post-EBRT	Experimental	Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT) Receives: Device: Prostatic Urethral Lift (PUL)
Prostatic Urethral Lift (PUL) pre-BT	Experimental	Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT) Receives: Device: Prostatic Urethral Lift (PUL)
Prostatic Urethral Lift (PUL) post-BT	Active comparator	Prostatic Urethral Lift (PUL) following Brachytherapy (BT) Receives: Device: Prostatic Urethral Lift (PUL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:
≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.
Measured: 3 months post-PUL placement
Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met:
- 30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.
Measured: 3 months post-BT

Secondary outcomes (10)

Mean change in International Prostate Symptom Score (IPSS)
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia.
Mean change in IPSS score will be reported
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in peak urinary flow rate (Qmax)
Qmax is the quantity of urine measured over a specified period of time. A significant outcome would be a greater than 50% change in Qmax.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Quality of life scores from last question on IPSS questionnaire
QOL score (last question in the IPSS questionnaire): If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?
With answer options on a 0-6 scale with 0 being delighted and 6 being terrible.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores
The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire with four questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.
Mean change in BPHII score will be reported.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in the MSHQ total score
Men's Sexual Health Questionnaire (MSHQ) is a 18-item questionnaire focused on assessing three core function domains (erection, ejaculation and satisfaction).
Mean change in the MSHQ ejaculation total score will be reported.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by number of pads used
Assessment of urinary incontinence associated with the procedure measured by change number of pads used per day.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by quality of stress or urge
Assessment of urinary incontinence associated with the procedure as measured by quality: stress or urge.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by cough stress test
Assessment of urinary incontinence associated with the procedure as measured by cough test.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by time to resolve
Assessment of urinary incontinence associated with the procedure as measured by time to resolve.
Measured: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in post-void residual (PVR)
Assessment of PVR, the amount of urine left in the bladder after urination.
Measured: 3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201930 Mar 2023

First posted25 Jan 2019
Study startDec 2019 (estimated)
Primary completion30 Jun 2022 (estimated)
Study completion30 Mar 2023 (estimated)

Why it stopped: re-written and submitted as a new study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe 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: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03817216
Sponsor's protocol ID: CASE10818
Status last verified: Mar 2020
First submitted: 4 Dec 2018
Last updated: 12 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms
ClinicalTrials.gov ID: NCT03817216
Acronym / sponsor ID: CASE10818
Conditions: Benign Prostatic Hyperplasia (BPH), Prostate Cancer
Keywords: Prostatic Urethral Lift (PUL)
Study type: Interventional
Recruitment status: WithdrawnReason stopped: re-written and submitted as a new study
Enrolment: 0 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: Dec 2019 (estimated)
Primary completion: 30 Jun 2022 (estimated)
Study completion: 30 Mar 2023 (estimated)
First posted: 25 Jan 2019 (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.

Detailed description

For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy (BT) from pre-PUL baseline.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Prostatic Urethral Lift (PUL) post-EBRT	Experimental	Device: Prostatic Urethral Lift (PUL)Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT)
Prostatic Urethral Lift (PUL) pre-BT	Experimental	Device: Prostatic Urethral Lift (PUL)Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT)
Prostatic Urethral Lift (PUL) post-BT	Active comparator	Device: Prostatic Urethral Lift (PUL)Prostatic Urethral Lift (PUL) following Brachytherapy (BT)

Who may qualify

Ages: 51 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

International Prostate Symptom Score ≥ 12.
Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).

Key exclusion criteria (6 listed)

Obstructive median lobe of the prostate.
Active urinary tract infection.
Neurogenic non-obstructive voiding dysfunction.
Obstructive symptoms secondary to prostate cancer (via cystoscopy).
Patients with prior Transurethral resection of the prostate (TURP).

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
Prostatic Urethral Lift (PUL)PUL/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH). This study evaluates UroLift's efficacy participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy.	Device	Prostatic Urethral Lift (PUL) post-BT, Prostatic Urethral Lift (PUL) post-EBRT, Prostatic Urethral Lift (PUL) pre-BT

Primary outcome

Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
Time frame: 3 months post-PUL placement
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: ≥ 30% or ≥ 4 point IPSS reduction 3 months after PUL.
Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
Time frame: 3 months post-BT
IPSS is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia. A mean change in International Prostate Symptom Score (IPSS) will be considered effective if the following condition is met: * 30% or ≥ 4 point IPSS reduction 3 months after BT from pre-PUL baseline.

10 secondary outcomes

Mean change in International Prostate Symptom Score (IPSS)
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in peak urinary flow rate (Qmax)
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Quality of life scores from last question on IPSS questionnaire
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in the MSHQ total score
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by number of pads used
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by quality of stress or urge
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by cough stress test
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Urinary incontinence measured by time to resolve
Time frame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
Mean change in post-void residual (PVR)
Time frame: 3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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ProVIDE Studies Post Exit Analysis
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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.

Irina Jaeger, MD principal investigator

University Hospitals Cleveland Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing Prostatic Urethral Lift (PUL) in people with Benign Prostatic Hyperplasia (BPH) and Prostate Cancer, run by Case Comprehensive Cancer Center.

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 6 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: withdrawn, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT (time frame: 3 months post-PUL placement). The study lists 2 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 NCT03817216.

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 12 Mar 2020.