Urolift Before SBRT to Try to Lower Urinary Side Effects in Men with BPH and Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores whether a pre-SBRT Urolift procedure reduces urinary toxicity in men with benign prostatic hyperplasia who require stereotactic body radiation therapy for prostate cancer. Patients will undergo a Urolift procedure prior to SBRT and will be monitored for urinary symptoms and quality of life. The trial builds on prior evidence that Urolift improves urinary function and medication needs in BPH patients. Outcomes include urinary frequency, dysuria, nocturia, and patient-reported quality of life. The study is conducted at Northwell Health with collaboration from NeoTract, Inc. and Teleflex.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject is 50 - 99 years of age
* Subject has provided informed consent
* Subject has diagnosis of prostate cancer requiring SBRT
* Subject is able to complete self-administered questionnaires
* Subject is a surgical candidate for Urolift
* Subject has a diagnosis of BPH
* Medical record documentation of prostate volume from 30-80 ml by TRUS
* Absence of a middle lobe

Exclusion Criteria:

* Life expectancy \< 2 years
* Currently enrolled in or plans to enroll in any concurrent drug or device study
* Concurrent androgen deprivation therapy
* Has an active infection (e.g., urinary tract infection or prostatitis)
* Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
* Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
* Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
* Diagnosis of lichen sclerosis
* Neurogenic bladder or other neurologic disorder that affects bladder function
* Diagnosis of polyneuropathy (e.g., diabetic)
* History of lower urinary tract surgery
* Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
* Subject has been catheterized or has a PVR \> 400 ml in the 14 days prior to the surgical procedure
* Current diagnosis of bladder stones

Where it's running

• Northwell Health
  Syosset, New York, United States Recruiting

Study contacts

• Principal investigator: Bilal Chughtai, MD — Northwell Health
• Study coordinator: Jennifer Polo, CCRC
• Email: jpolo1@northwell.edu
• Phone: 516-628-5910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.