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Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 99 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Urolift, a procedure that needs only minor surgery, can reduce urinary side effects from focused radiation treatment called SBRT. It is for people with prostate cancer who need SBRT and have BPH, an enlarged prostate that is not caused by cancer. The study looks at problems such as pain when peeing and needing to pee often or at night.

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 50 to 99 years old.
  • Have given informed consent to join the study.
  • Have prostate cancer that needs SBRT radiation treatment.
  • Can fill out questionnaires on your own.
  • Can safely have the Urolift procedure.
  • Have BPH, a noncancerous enlarged prostate.
  • Have a prostate size of 30–80 mL, recorded using an ultrasound through the rectum.
  • Do not have a middle lobe, a section of the prostate.

Who can't join

  • Are expected to live less than 2 years, or are in or plan to join another drug or device study at the same time.
  • Are receiving hormone treatment to lower male hormones.
  • Have an active infection, such as a urinary or prostate infection; or have been diagnosed with or treated for long-term prostate inflammation or pelvic pain.
  • Have had narrowing of the urine tube or bladder opening in the past 180 days, or at least 2 such narrowings in the past 5 years.
  • Have lichen sclerosis, a skin condition, or have bladder stones.
  • Have a nerve condition that affects bladder function, or damage to many nerves, such as from diabetes.
  • Have had surgery on the lower urinary tract, or leak urine with coughing or activity and need treatment or daily pads or devices.
  • Have used a tube to drain urine, or had more than 400 mL of urine left in the bladder after peeing, within 14 days before the procedure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY