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Radiation

UroLift + SAbR for Prostate Cancer

Q: Does the FDA certify all participants in this research?

The safety of those involved in this clinical trial was rated a 1, as Phase One trials possess only minimal evidence on efficacy and security.

Q: How many research participants are involved in this experiment?

Affirmative. According to the data hosted on clinicaltrials.gov, this ongoing study first appeared on January 11th 2023 and was recently updated on the 27th of that month. The trial is presently recruiting 15 participants from a single site.

Q: Is there still capacity for individuals to partake in this research protocol?

Affirmative. Information on clinicaltrials.gov confirms that this investigation, first posted in 11th January 2023, is currently enrolling individuals. Specifically, 15 participants need to be enrolled at a single location.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trialfound combining UroLift System with prostate cancer SAbR safe, with no increase in acute complications in patients with BPH.

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.Check my eligibility

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.See study design

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.

Select...

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

Select...

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

Select...

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

Select...

My health is good to moderately impaired.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Quality of Life with UroLift System

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

2013

Completed Phase 2

~70

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,760 Total Patients Enrolled

16 Trials studying Prostate Cancer

2,145 Patients Enrolled for Prostate Cancer

NeoTract, Inc.Industry Sponsor

10 Previous Clinical Trials

3,385 Total Patients Enrolled

Aurelie Garant, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Stereotactic Ablative Radiotherapy (SABR) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05311527 — Phase 1

Prostate Cancer Research Study Groups: All Study participants

Prostate Cancer Clinical Trial 2023: Stereotactic Ablative Radiotherapy (SABR) Highlights & Side Effects. Trial Name: NCT05311527 — Phase 1

Stereotactic Ablative Radiotherapy (SABR) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05311527 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA certify all participants in this research?

"The safety of those involved in this clinical trial was rated a 1, as Phase One trials possess only minimal evidence on efficacy and security."

Answered by AI

How many research participants are involved in this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this ongoing study first appeared on January 11th 2023 and was recently updated on the 27th of that month. The trial is presently recruiting 15 participants from a single site."

Answered by AI

Is there still capacity for individuals to partake in this research protocol?

"Affirmative. Information on clinicaltrials.gov confirms that this investigation, first posted in 11th January 2023, is currently enrolling individuals. Specifically, 15 participants need to be enrolled at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

UroLift System With SAbR for Prostate Cancer and BPH

Aurelie Garant 2023. "UroLift System With SAbR for Prostate Cancer and BPH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05311527.

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