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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
Must not have
Unresolved urinary tract infection or prostatitis
Less than 10 years life expectancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
My treatment plan involves targeting a small area near the urethra, confirmed by a recent MRI.
Select...
I have not received any treatment for my condition.
Select...
My prostate cancer is classified as ISUP grade 2 or 3.
Select...
My cancer is localized and has not spread to lymph nodes or other parts.
Select...
My prostate cancer is intermediate-risk with a Gleason grade of 2 or 3.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I currently have a urinary tract infection or prostatitis that hasn't healed.
Select...
My doctor expects I have less than 10 years to live.
Select...
I have had issues with severe bladder problems or bleeding in my urine.
Select...
My tumor is either more than 30 mm or less than 14 mm from the prostatic urethra.
Select...
I cannot have an MRI or be put under general anesthesia.
Select...
I have prostate calcifications larger than 3 mm that may interfere with tumor treatment.
Select...
I have an artificial urinary sphincter, penile implant, or intraprostatic implant.

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

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

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: 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
PSMA PET Scan
2020
N/A
~10
Multiparametric Magnetic Resonance Imaging
2021
Completed Early Phase 1
~10
Bone Scan
2015
Completed Phase 2
~50
Biopsy
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,055 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,981 Total Patients Enrolled
27 Trials studying Prostate Cancer
6,970 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
David A WoodrumPrincipal InvestigatorMayo Clinic in Rochester

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
~1 spots leftby Mar 2025
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