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Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Primary Purpose

Benign Prostatic Hyperplasia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urolift
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring stereotactic body radiation therapy, urolift, prostatic urethral lift, dysuria, nocturia, minimally invasive therapy

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is 40 - 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

Sites / Locations

  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urolift

Arm 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.

Outcomes

Primary Outcome Measures

Change in IPSS scores from baseline and one year post treatment
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.
Change in IIEF score through study completion, an average of 1 year
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Change in MSHQ through study completion, an average of 1 year
Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year. Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Change in VAS score through study completion, an average of 1 year
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
Change in OAB-SF score through study completion, an average of 1 year
Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms. The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
Change in SF-12 score through study completion, an average of 1 year
Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.

Secondary Outcome Measures

Change in medication usage through study completion, an average of 1 year
Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment

Full Information

First Posted
November 23, 2021
Last Updated
October 12, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
NeoTract, Inc., Teleflex
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1. Study Identification

Unique Protocol Identification Number
NCT05148156
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Principal Investigator changing locations.
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
NeoTract, Inc., Teleflex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
stereotactic body radiation therapy, urolift, prostatic urethral lift, dysuria, nocturia, minimally invasive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urolift
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Urolift
Intervention Description
Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).
Primary Outcome Measure Information:
Title
Change in IPSS scores from 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.
Time Frame
At baseline and one year post treatment
Title
Change in IIEF score through study completion, an average of 1 year
Description
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Time Frame
Through study completion, an average of 1 year
Title
Change in MSHQ through study completion, an average of 1 year
Description
Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year. Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Time Frame
Through study completion, an average of 1 year
Title
Change in VAS score through study completion, an average of 1 year
Description
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
Time Frame
through study completion, an average of 1 year
Title
Change in OAB-SF score through study completion, an average of 1 year
Description
Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms. The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
Time Frame
Through study completion, an average of 1 year
Title
Change in SF-12 score through study completion, an average of 1 year
Description
Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in medication usage through study completion, an average of 1 year
Description
Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is 40 - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilal Chughtai, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32644346
Citation
Ng M, Baradhi KM. Benign Prostatic Hyperplasia. 2022 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/
Results Reference
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PubMed Identifier
16613526
Citation
McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8.
Results Reference
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PubMed Identifier
19027219
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.
Results Reference
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PubMed Identifier
27476128
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.
Results Reference
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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.
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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.
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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.
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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.
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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.
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Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

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