Can a prostate implant ease urinary problems during cancer radiation?
NCT ID NCT05311527
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase I safety trial tested whether using the UroLift system—a device that lifts and holds enlarged prostate tissue out of the way—before stereotactic ablative body radiotherapy (SABR) is safe for men with both prostate cancer and benign prostatic hyperplasia (BPH). Fifteen men with low- to intermediate-risk prostate cancer and BPH received the UroLift implant followed by SABR. The main goal was to check for serious complications within 90 days after treatment, with secondary goals looking at urinary, sexual, and bowel quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UroLift implant and stereotactic ablative body radiotherapy (SABR)
- What this could lead to
- If successful, this approach could offer a way to manage BPH symptoms during prostate cancer radiation, potentially improving urinary quality of life.
- What could go wrong
- This is a very small, early safety trial with only 15 participants, so results may not apply widely. The combination could still cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * AJCC 8th edition clinical stage T1 (a, b, or c) or T2 (a, b, or c) adenocarcinoma of the prostate gland, Gleason 3+3 = 6 or 3+4 = 7, with no direct evidence of regional or distant metastases following appropriate staging studies. See Appendix I for details on AJCC 8th Edition staging criteria. T-staging may be assessed by multi-parametric imaging alone if digital rectal examination was deferred * Histologic confirmation of prostate cancer is required by biopsy performed within 18 months of registration. * Age ≥ 45 years. * Eastern Cooperative Oncology Group (ECOG) Performance status 0-1. * American Society of Anesthesia (ASA) physical status score of 1-3 * Baseline AUA symptom score ≥ 17 regardless of medical therapy * The serum PSA should be ≤ 20 ng/ml within 120 days of registration * Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT or anti-androgen therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride; (5) within 5 days of a digital rectal examination * Ultrasound or MRI based volume estimation of prostate gland \< 100 grams, regardless of cytoreduction with pharmacotherapy * Ability to undergo general anesthesia for \<60 minutes * Ability to understand and the willingness to sign a written informed consent. * All men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: * Contraindications to UroLift System placement including: * Prostate volume \>100 cc based on imaging-based estimation * Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder * Urinary incontinence due to incompetent sphincter * An active urinary tract infection * Current gross hematuria In addition to the contraindications if there is a known allergy to nickel, titanium, or stainless steel these patients should be excluded * Prior transurethral resection of the prostate (TURP), median lobe manipulation, simple prostatectomy, or other ablative procedures for benign prostatic hyperplasia. * Foley / self-catheterization in the last 12 months. * Patients with all three intermediate risk factors (PSA \>10 and ≤ 20, Gleason 7, clinical stage T2b-T2c) who ALSO have ≥50% of the number of their template biopsy cores positive for cancer are ineligible. * Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer. * Current active androgen deprivation therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
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