Clinical trial · Interventional
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)
NCT05148156CI-TRIAL-00101686suspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator changing locations.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Urolift | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Urolift
- description
- This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.
- interventionNames
- Device: Urolift
Primary outcomes (6)
- measure
- Change in IPSS scores from baseline and one year post treatment
- timeFrame
- At baseline and one year post treatment
- description
- Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
- measure
- Change in IIEF score through study completion, an average of 1 year
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDNg M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/ PMID 32644346
- BACKGROUNDMcVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8. PMID 16613526
- BACKGROUNDAlcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21. PMID 19027219
- BACKGROUNDRoehrborn CG. Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. 2016 Aug;43(3):357-69. doi: 10.1016/j.ucl.2016.04.008. PMID 27476128
- BACKGROUNDChialastri P, Chialastri A, Mueller T. Does Prostatic Urethral Lift Reduce Urinary Medications? Trends in Medical Treatment Before and After Prostatic Urethral Lift. J Endourol. 2021 May;35(5):657-662. doi: 10.1089/end.2020.0848. Epub 2021 Jan 20. PMID 33198488
- BACKGROUNDCihan Y. The role and importance of SBRT in prostate cancer. Int Braz J Urol. 2018 Nov-Dec;44(6):1272-1274. doi: 10.1590/S1677-5538.IBJU.2018.0484. No abstract available. PMID 30325604
- BACKGROUNDJanowski E, Chen LN, Kim JS, Lei S, Suy S, Collins B, Lynch J, Dritschilo A, Collins S. Stereotactic body radiation therapy (SBRT) for prostate cancer in men with large prostates (>/=50 cm(3)). Radiat Oncol. 2014 Nov 15;9:241. doi: 10.1186/s13014-014-0241-3. PMID 25398516
- Mbeutcha A, Chauveinc L, Bondiau PY, Chand ME, Durand M, Chevallier D, Amiel J, Kee DL, Hannoun-Levi JM. Salvage prostate re-irradiation using high-dose-rate brachytherapy or focal stereotactic body radiotherapy for local recurrence after definitive radiation therapy. Radiat Oncol. 2017 Mar 9;12(1):49. doi: 10.1186/s13014-017-0789-9.