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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer; Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Device: Prostatic Urethral Lift (PUL)

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months post-BT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	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.	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.	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.	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.	3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Irina Jaeger, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Prostatic Urethral Lift (PUL)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CASE10818

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes