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