Prostate CancerNCT05311527
UroLift System With SAbR for Prostate Cancer and BPH
A study testing Urolift and SABR in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion) Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Urolift and SABR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
About this study
Official title: Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Safety Trial
Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)
Read the detailed description
UroLift System implant will be implanted transurethrally under cystoscopic guidance with a UroLift System Delivery Device by a trained provider. Optimal placement of the implants will be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted but more or less can be placed per provided discretion, up to a maximum of 10 implants per manufacturer specifications.
Given that patients will also undergo UroLift System placement, patients will be offered to undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one single procedure, under general anesthesia.
SAbR will be performed following placement of UroLift System, prostate fiducials, rectal spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema, prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder filling protocol, and appropriate imaging verification.
- Conditions
- Prostate Cancer
- Being tested
- Urolift, SABR
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroliftDevice
Urolift Implant
SABRRadiation
Also called SBRT
Stereotactic Body Radiation Therapy for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| All Study participants | Experimental | Study participants will undergo Urolift System followed by SABR Receives: Device: Urolift; Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia
Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.
Measured: 90 days
Secondary outcomes (1)
Quality of Life with UroLift System
AUA, EPIC-26 questionnaires and Noninvasive urodynamics will be obtained, these data will be analyzed once all patients have completed the scheduled trial visits.The aggregate score will be done for (urinary, sexual, bowel, and health-related) associated with UroLift System when administered prior to SABR.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start11 Jan 2023
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NeoTract, Inc.
- Responsible party
- Principal investigator, Aurelie Garant, University of Texas Southwestern Medical Center
- Investigators
- Aurelie Garant, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311527
- Sponsor's protocol ID
- STU-2022-0261
- Status last verified
- Oct 2025
- First submitted
- 15 Mar 2022
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using UroLift System With Stereotactic Ablative Body Radiotherapy For Men With Prostate Cancer and Benign Prostatic Hyperplasia (BPH): a Phase I Safety Trial
- ClinicalTrials.gov ID
- NCT05311527
- Acronym / sponsor ID
- STU-2022-0261
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- NeoTract, Inc.
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)
Detailed description
UroLift System implant will be implanted transurethrally under cystoscopic guidance with a UroLift System Delivery Device by a trained provider. Optimal placement of the implants will be verified cystoscopically. On average, 4-6 UroLift System implants are typically implanted but more or less can be placed per provided discretion, up to a maximum of 10 implants per manufacturer specifications.
Given that patients will also undergo UroLift System placement, patients will be offered to undergo UroLift System, fiducial marker placement and rectal gel spacer placement in one single procedure, under general anesthesia.
SAbR will be performed following placement of UroLift System, prostate fiducials, rectal spacer, and MR/CT simulation, using stereotactic immobilization/localization, rectal enema, prophylactic medication support (tamsulosin, dexamethasone unless contraindicated), bladder filling protocol, and appropriate imaging verification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study participants | Experimental | Device: Urolift, Radiation: SABRStudy participants will undergo Urolift System followed by SABR |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroliftUrolift Implant | Device | All Study participants |
| SABRAlso: SBRTStereotactic Body Radiation Therapy for prostate cancer | Radiation | All Study participants |
Primary outcome
Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia
Time frame: 90 days
Analyses will be performed for all subjects having received at least one fraction of radiation therapy. The study will use CTCAE version 5.0 for reporting of adverse events and, for reporting purposes, will also capture Clavien-Dindo grading system for the classification of surgical complications for reporting adverse events related to the UroLift System procedure.
1 secondary outcome
Quality of Life with UroLift System
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelie Garant, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urolift and SABR in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.