Clinical trial NCT03817216: Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer
Official title: Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer: Prospective Analysis of Outcomes in Patients With Obstructive Urinary Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Prostate Cancer
Keywords: Prostatic Urethral Lift (PUL)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 0
Sex: MALE
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in International Prostate Symptom Score (IPSS) - Arms: PUL placement post-EBRT and PUL placement post-BT
timeFrame: 3 months post-PUL placement
measure: Mean change in International Prostate Symptom Score (IPSS) - Arm: PUL placement pre-BT.
timeFrame: 3 months post-BT
Secondary outcomes:
measure: Mean change in International Prostate Symptom Score (IPSS)
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Mean change in peak urinary flow rate (Qmax)
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Quality of life scores from last question on IPSS questionnaire
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Mean change in Benign Prostatic Hyperplasia Impact Index (BPHII) scores
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Mean change in the MSHQ total score
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Urinary incontinence measured by number of pads used
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Urinary incontinence measured by quality of stress or urge
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Urinary incontinence measured by cough stress test
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Urinary incontinence measured by time to resolve
timeFrame: 6 and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms)
measure: Mean change in post-void residual (PVR)
timeFrame: 3, 6, and 12 months post-BT (pre-BT arm) or post-PUL placement (Post-BT & Post-EBRT arms
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Irina Jaeger, MD
role: PRINCIPAL_INVESTIGATOR
References: