Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prostatic Urethral Lift (PUL) post-EBRT Prostatic Urethral Lift (PUL) following External Beam Radiotherapy (EBRT) |
Device: 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.
|
| Experimental: Prostatic Urethral Lift (PUL) pre-BT Prostatic Urethral Lift (PUL) preceding Brachytherapy (BT) |
Device: 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.
|
| Active Comparator: Prostatic Urethral Lift (PUL) post-BT Prostatic Urethral Lift (PUL) following Brachytherapy (BT) |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT [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. [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.
Secondary Outcome Measures
- Mean change in International Prostate Symptom Score (IPSS) [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
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
- Mean change in peak urinary flow rate (Qmax) [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
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.
- Quality of life scores from last question on IPSS questionnaire [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
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.
- Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
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.
- Mean change in the MSHQ total score [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
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.
- Urinary incontinence measured by number of pads used [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
Assessment of urinary incontinence associated with the procedure measured by change number of pads used per day.
- Urinary incontinence measured by quality of stress or urge [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
Assessment of urinary incontinence associated with the procedure as measured by quality: stress or urge.
- Urinary incontinence measured by cough stress test [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
Assessment of urinary incontinence associated with the procedure as measured by cough test.
- Urinary incontinence measured by time to resolve [6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)]
Assessment of urinary incontinence associated with the procedure as measured by time to resolve.
- Mean change in post-void residual (PVR) [3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms]
Assessment of PVR, the amount of urine left in the bladder after urination.
Eligibility Criteria
Criteria
Inclusion Criteria:
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International Prostate Symptom Score ≥ 12.
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Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
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Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).
Exclusion Criteria:
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Obstructive median lobe of the prostate.
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Active urinary tract infection.
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Neurogenic non-obstructive voiding dysfunction.
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Obstructive symptoms secondary to prostate cancer (via cystoscopy).
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Patients with prior Transurethral resection of the prostate (TURP).
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Patients with prior history of urethral stricture.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Principal Investigator: Irina Jaeger, MD, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE10818