BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperp… (NCT01520441) | Clinical Trial Compass
WithdrawnEarly Phase 1
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)
United States0Started 2011-03
Plain-language summary
This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.
Who can participate
Age range
50 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:
* Biopsy proven, clinically localized prostate cancer
* Low risk for recurrence defined as a Kattan nomogram score of less than 115, or a serum PSA \< 10ng/ml, or an individual Gleason grade of 3 or lower, or clinical stage T2b or below.
* Candidates diagnosed with localized prostate cancer must have agreed to radical prostatectomy.
* Voided volume greater than or equal to 125 ml.
* Maximum urinary flow less than 15 ml/sec.
* American Urological Association (AUA) symptom severity score greater than or equal to 8.
* Patient signed informed consent prior to the performance of any study procedures.
* Patient able to complete the study protocol in the opinion of the investigator.
Exclusion Criteria:
* Any prior surgical intervention for BPH.
* Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
* History of bladder stones.
* Overactive bladder without bladder outlet obstruction.
* Enrolled in another treatment trial for any disease within the past 30 days.
* Previous exposure to botulinum toxin.
* Post void residual greater than 350 ml.
* Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values).
* Daily use of a pad or device for incontinence required.
* Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months.
* On aminoglycosides or any drug that …
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
Determination the effects of BoNT-A injection on BPH and prostate cancer tissues.
Timeframe: 3 years
Trial details
NCT IDNCT01520441
SponsorThe University of Texas Health Science Center, Houston