What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as the UroLift System, which mechanically lifts and holds prostate tissue to relieve urinary obstruction, generally have minimal impact on sexual function and offer rapid recovery. However, other treatments like radical prostatectomy and radiation therapy can have more significant side effects. Radical prostatectomy often leads to urinary incontinence and sexual dysfunction, with some patients experiencing persistent issues even after two years. Radiation therapy, including external beam radiation and brachytherapy, can cause bowel symptoms like urgency and frequency, as well as sexual dysfunction. These side effects tend to persist in a notable percentage of patients over time.

What prior FDA approvals exist?

The UroLift System, which mechanically lifts and holds prostate tissue to relieve urinary obstruction, is primarily used for treating benign prostatic hyperplasia (BPH) rather than prostate cancer. For prostate cancer, FDA-approved treatments include androgen deprivation therapy (ADT), chemotherapy, and newer hormonal agents like abiraterone and enzalutamide. Minimally invasive treatments like the UroLift System are not typically used for prostate cancer but are effective for managing urinary symptoms associated with BPH.

What other types of research exist?

Promising novel alternatives to the UroLift System for prostate cancer patients include robotic-assisted lower genitourinary tract reconstruction, which offers precise articulation for dissection and suturing, and the adjustable perineal male sling, which allows postoperative tension adjustment over the urethra. Additionally, advancements in robotic-assisted surgery for benign prostatic hyperplasia (BPH) and the development of artificial transplants for ureteral reconstruction are noteworthy.

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Radiation

UroLift + SAbR for Prostate Cancer

Q: What is the mechanism of action of this treatment?

The UroLift System mechanically lifts and holds the enlarged prostate tissue, relieving urinary obstruction without cutting, heating, or removing tissue, offering a minimally invasive option with fewer side effects. Other common treatments include radical prostatectomy (surgical removal of the prostate gland), radiation therapy (high-energy rays to kill cancer cells), and hormone therapy (reducing or blocking testosterone production). These treatments are essential for managing or eradicating cancer while preserving the patient's quality of life by minimizing adverse effects.

Phase 1

Recruiting

Led By Aurelie Garant, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.

Age > 45 years.

Must not have

Prior pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.

Urethral conditions (e.g. urethral strictures and neoplams) that may prevent insertion of UroLift System delivery system into the bladder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial combines the UroLift System, which helps men with an enlarged prostate by opening up the urinary passage, with a precise radiation treatment for prostate cancer. It targets men who have both conditions to improve their treatment outcomes. The UroLift System is a minimally invasive treatment designed to improve lower urinary tract symptoms in men with an enlarged prostate without affecting sexual function.

Who is the study for?

Men over 45 with early-stage prostate cancer and BPH, ECOG status 0-1, ASA score of 1-3. PSA <20 ng/ml, willing to use contraception. No prior prostate treatments or active infections; no urinary incontinence or conditions preventing UroLift insertion.

What is being tested?

The trial tests the safety of using the UroLift System before Stereotactic Ablative Radiotherapy (SAbR) in men with newly diagnosed prostate cancer who also have BPH by monitoring complications within 90 days post-treatment.

What are the potential side effects?

Potential side effects may include discomfort from UroLift implantation, typical risks associated with general anesthesia, and common radiotherapy side effects like fatigue, skin reactions, and urinary issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am older than 45 years.

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My urinary symptoms are severe, with an AUA score of 17 or more.

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My prostate cancer is early stage, not spread, with specific Gleason scores.

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My prostate is smaller than 100 grams, as measured by ultrasound or MRI.

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My health is good to moderately impaired.

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I can be safely put under general anesthesia for less than an hour.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatments like radiotherapy, chemotherapy, or surgery for prostate cancer.

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I don't have urethral conditions that would prevent UroLift System procedures.

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I am currently on hormone therapy for cancer.

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I have urinary incontinence because of a weak bladder sphincter.

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I currently have a urinary tract infection.

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I have had surgery or procedures for an enlarged prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of UroLift implant when combined with SAbR for men with prostate cancer and benign prostatic hyperplasia

Secondary study objectives

Quality of Life with UroLift System

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All Study participantsExperimental Treatment2 Interventions

Study participants will undergo Urolift System followed by SABR

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SABR

2012

Completed Phase 2

~110

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The UroLift System mechanically lifts and holds the enlarged prostate tissue, relieving urinary obstruction without cutting, heating, or removing tissue, offering a minimally invasive option with fewer side effects. Other common treatments include radical prostatectomy (surgical removal of the prostate gland), radiation therapy (high-energy rays to kill cancer cells), and hormone therapy (reducing or blocking testosterone production). These treatments are essential for managing or eradicating cancer while preserving the patient's quality of life by minimizing adverse effects.