Clinical trial NCT05148156: Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Official title: Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: stereotactic body radiation therapy
urolift
prostatic urethral lift
dysuria
nocturia
minimally invasive therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: NeoTract, Inc.
name: Teleflex
First posted: 2021-12-08
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy
Primary purpose: TREATMENT

Brief 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).

Detailed description: Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

Eligibility criteria: 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 \&amp;lt; 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 \&amp;gt; 400 ml in the 14 days prior to the surgical procedure
* Current diagnosis of bladder stones

Primary outcomes:
measure: Change in IPSS scores from baseline and one year post treatment
timeFrame: At baseline and one year post treatment
measure: Change in IIEF score through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
measure: Change in MSHQ through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
measure: Change in VAS score through study completion, an average of 1 year
timeFrame: through study completion, an average of 1 year
measure: Change in OAB-SF score through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
measure: Change in SF-12 score through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Change in medication usage through study completion, an average of 1 year
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Syosset
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Bilal Chughtai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/
citation: McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8.
citation: Alcaraz 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.
citation: Roehrborn 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.
citation: Chialastri 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.
citation: Cihan 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.
citation: Janowski 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.
citation: 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.
citation: Fuller DB, Wurzer J, Shirazi R, Bridge SS, Law J, Mardirossian G. High-dose-rate stereotactic body radiation therapy for postradiation therapy locally recurrent prostatic carcinoma: Preliminary prostate-specific antigen response, disease-free survival, and toxicity assessment. Pract Radiat Oncol. 2015 Nov-Dec;5(6):e615-23. doi: 10.1016/j.prro.2015.04.009. Epub 2015 Jun 6.
citation: Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.