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
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
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
NCT ID
NCT05148156
First Posted
November 23, 2021
Last Updated
October 12, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
NeoTract, Inc., Teleflex
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
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Results Reference
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Citation
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Citation
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Results Reference
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Citation
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Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
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