Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Sponsor
- Case Comprehensive Cancer Center
- Primary Endpoint
- Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •International Prostate Symptom Score ≥
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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)