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Procedure

MRI-Guided Ultrasound Ablation for Prostate Cancer

N/A
Recruiting
Led By David A Woodrum, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
Treatment naive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new, minimally invasive treatment for intermediate grade prostate cancer. The treatment uses ultrasound to kill cancer cells and may help patients avoid surgery.

Who is the study for?
Men aged 45-80 with intermediate-grade prostate cancer (Gleason grade 2 or 3) that hasn't spread beyond the prostate and is suitable for MRI. They should have a life expectancy over 10 years, no prior treatments, and be able to undergo MRI and anesthesia. Exclusions include severe urinary problems, certain implants, infections, or conditions affecting device insertion.Check my eligibility
What is being tested?
The trial tests MRI-guided TULSA for treating intermediate prostate cancer. It's less invasive than surgery and uses ultrasound to heat and destroy cancer cells. The study also assesses how this treatment affects patients' quality of life through questionnaires.See study design
What are the potential side effects?
Potential side effects may include discomfort from the procedure, risks associated with anesthesia, possible irritation in the treated area leading to urinary issues, as well as general risks of infection or bleeding post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My treatment plan involves targeting a small area near the urethra, confirmed by a recent MRI.
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I have not received any treatment for my condition.
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My prostate cancer is classified as ISUP grade 2 or 3.
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My cancer is localized and has not spread to lymph nodes or other parts.
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My prostate cancer is intermediate-risk with a Gleason grade of 2 or 3.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients free from treatment failure
Proportion of patients who maintain both urinary continence and erectile potency
Secondary outcome measures
Biochemical failure
Biochemical failure-free survival
Change in patient-reported genitourinary function
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (MRI-guided TULSA)Experimental Treatment9 Interventions
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cystoscopy
2016
Completed Phase 4
~810
Biopsy
2014
Completed Phase 4
~1090
PSMA PET Scan
2020
N/A
~10

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,319 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,080 Patients Enrolled for Prostate Cancer
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,845 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,373 Patients Enrolled for Prostate Cancer
David A Woodrum, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

MRI-Guided Transurethral Ultrasound Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05438563 — N/A
MRI-Guided Transurethral Ultrasound Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438563 — N/A

Frequently Asked Questions

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

What results are expected from this medical experiment?

"The purpose of this two-year clinical investigation is to evaluate the ability of patients to retain urinary continence and erectile potency. Secondary objectives measure histologic failure—clinically significant disease with a Gleason grade group 2 or higher, salvage-free survival estimated utilizing Kaplan–Meier analysis, total prostate volume at 24 months post initial treatment for those that have repeat TULSA procedure, as well as findings from MRI imaging conducted when deemed necessary by medical professionals."

Answered by AI

Are those who are younger than 55 eligible to participate in this experiment?

"This clinical trial has a narrow age range of 45 to 80. Conversely, there are 76 trials for minors and 1315 medical studies available for seniors."

Answered by AI

Do any medical facilities currently have open enrollment for this trial?

"Affirmative, the information on clinicaltrials.gov indicates that this research study is actively enlisting participants. It was initially uploaded to the website on April 6th 2022 and has since been modified as of August 22nd 2022. 10 people are being sought from a single healthcare facility for enrollment in the trial."

Answered by AI

Is it possible for me to partake in this research initiative?

"This clinical trial is recruiting 10 individuals who possess the following characteristics: Male, between 45 and 80 years of age with a life expectancy greater than ten years; Untreated prostate cancer where the ablation volume does not exceed 3.0 cm axial radius from urethra on mpMRI taken within 6 months of baseline; NCCN intermediate-risk (either favorable Gleason grade 2 or unfavorable GG3) disease no greater than Stage T2c, N0, M0 as confirmed by biopsy (minimum 8 cores if TRUS-guided while minimum 3 cores should come from each PI-RADS v2 category >=3 les"

Answered by AI

How many participants have been recruited for this research project?

"Affirmative, clinicaltrials.gov displays that this clinical trial is currently enrolling patients. It was initially posted on April 6th 2022 and the most recent version was released August 22nd. A total of 10 individuals are needed across a single site for completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer
David A. Woodrum 2022. "MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438563.
~4 spots leftby Mar 2025
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