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Ultrasound Therapy

MRI-guided Transurethral Ultrasound Ablation for Prostate Cancer (TACT Trial)

N/A
Waitlist Available
Led By Scott Eggener, MD
Research Sponsored by Profound Medical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male, age 45 to 80 years
Eligible for general anesthesia (ASA category ≤ 3)
Must not have
History of acute urinary retention within the last 12 months
Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses MRI-guided ultrasound to destroy prostate tissue in 150 patients. The goal is to evaluate the safety and effectiveness of this new therapy.

Who is the study for?
Men aged 45-80 with localized prostate cancer, a Gleason score ≤3+4, PSA ≤15 ng/ml, and a prostate size within specific MRI measurements. They must be eligible for MRI and general anesthesia, have no major organ issues or severe bladder problems, not on certain medications like hormone therapy recently, and without prior prostate cancer treatments.
What is being tested?
The study is testing the safety and effectiveness of TULSA-PRO system which uses ultrasound guided by MRI to target and destroy prostate tissue in patients with localized prostate cancer. It's a single-arm trial involving about 150 men who will all receive this treatment.
What are the potential side effects?
Potential side effects may include discomfort from the procedure itself, urinary symptoms such as frequency or urgency, possible erectile dysfunction due to nerve damage during ablation, as well as risks associated with any medical procedure like infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged between 45 and 80.
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I am considered fit for general anesthesia.
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My prostate is small enough based on recent MRI measurements.
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My cancer is in an early stage and has not grown deeply.
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My prostate is smaller than 90 cc according to my latest MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had trouble urinating in the past year.
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I have been treated for prostatitis within the last 6 months.
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My MRI shows a significantly enlarged median lobe of the prostate.
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I have had issues with my bladder or urethra, such as strictures or surgeries.
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I have a history of chronic inflammation in my rectum, such as ulcerative colitis.
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My cancer has spread beyond its original location.
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My MRI shows a tumor very close to the urethra or near the bottom of my prostate.
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I have completed my initial treatment for prostate cancer.
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I have had surgery to remove part of my prostate.
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I am currently experiencing visible blood in my urine that has not been treated.
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I cannot have MRI contrast due to severe kidney issues, sickle cell, anemia, or allergies.
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I have leg pain when walking or Leriches Syndrome.
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I have severe bladder control issues due to nerve problems.
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I have been diagnosed with Parkinson's disease or multiple sclerosis.
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I do not have HIV, AIDS, hepatitis B, or hepatitis C.
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I have swelling in one or both of my kidneys due to urine buildup.
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I have had major surgery or radiation therapy in my rectal or pelvic area.
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I have diabetes with complications or my Hemoglobin A1c is over 7%.
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I have bladder stones that have not been treated.
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I currently have an untreated UTI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Safety Endpoint - Incidence of treatment-emergent adverse events
Secondary study objectives
CE-MRI Endpoint
EPIC Endpoint
Erectile Dysfunction Endpoint
+10 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: MRI-guided Transurethral Ultrasound Ablation DeviceExperimental Treatment1 Intervention
Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.

Find a Location

Who is running the clinical trial?

Profound Medical Inc.Lead Sponsor
3 Previous Clinical Trials
1,231 Total Patients Enrolled
2 Trials studying Prostate Cancer
1,030 Patients Enrolled for Prostate Cancer
Scott Eggener, MDPrincipal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
760 Total Patients Enrolled
1 Trials studying Prostate Cancer
198 Patients Enrolled for Prostate Cancer

Media Library

MRI-guided Transurethral Ultrasound Ablation (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02766543 — N/A
Prostate Cancer Research Study Groups: MRI-guided Transurethral Ultrasound Ablation Device
Prostate Cancer Clinical Trial 2023: MRI-guided Transurethral Ultrasound Ablation Highlights & Side Effects. Trial Name: NCT02766543 — N/A
MRI-guided Transurethral Ultrasound Ablation (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02766543 — N/A
~2 spots leftby Dec 2024
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