Prostate Cancer Clinical Trial
Official title:
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.
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.
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