Prostate Cancer Clinical Trial

Urolift for Reduction of SBRT

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).

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT05148156

Recruitment Status:

Recruiting

Sponsor:

Weill Medical College of Cornell University

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There is 1 Location for this study

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Weill Cornell Medicine
New York New York, 10065, United States More Info
Rabia Bukhari
Contact
646-962-9395
[email protected]
Rabia Bukhari, RN
Contact
6469629395
[email protected]
Bilal Chughtai, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

20

Study ID:

NCT05148156

Recruitment Status:

Recruiting

Sponsor:


Weill Medical College of Cornell University

How clear is this clinincal trial information?

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