Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer. (NCT05148156) | Clinical Trial Compass
SuspendedNot Applicable
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Stopped: Principal Investigator changing locations.
United States20 participantsStarted 2021-12-15
Plain-language summary
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).
Who can participate
Age range
50 Years – 99 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in IPSS scores from baseline and one year post treatment
Timeframe: At baseline and one year post treatment
2
Change in IIEF score through study completion, an average of 1 year
Timeframe: Through study completion, an average of 1 year
3
Change in MSHQ through study completion, an average of 1 year
Timeframe: Through study completion, an average of 1 year
4
Change in VAS score through study completion, an average of 1 year
Timeframe: through study completion, an average of 1 year
5
Change in OAB-SF score through study completion, an average of 1 year
Timeframe: Through study completion, an average of 1 year
6
Change in SF-12 score through study completion, an average of 1 year
Timeframe: Through study completion, an average of 1 year