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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
TACT Trial 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.Check my eligibility
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.See study design
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.
TACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 45 and 80.
Select...
I am considered fit for general anesthesia.
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My prostate is small enough based on recent MRI measurements.
Select...
My cancer is in an early stage and has not grown deeply.
Select...
My prostate is smaller than 90 cc according to my latest MRI.
TACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
CE-MRI Endpoint
EPIC Endpoint
Erectile Dysfunction Endpoint
+10 moreTACT 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.
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Who is running the clinical trial?
Profound Medical Inc.Lead Sponsor
3 Previous Clinical Trials
1,231 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,231 Patients Enrolled for Prostate Cancer
Scott Eggener, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
562 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had trouble urinating in the past year.My prostate cancer has a Gleason score of 7 or less.I have been treated for prostatitis within the last 6 months.My MRI shows a significantly enlarged median lobe of the prostate.I have had issues with my bladder or urethra, such as strictures or surgeries.You have received any experimental treatment for prostate issues within the past 6 months.I haven't used hormone therapy or 5-ARIs in the last 3 months.I have a history of chronic inflammation in my rectum, such as ulcerative colitis.My cancer has spread beyond its original location.My MRI shows a tumor very close to the urethra or near the bottom of my prostate.I have completed my initial treatment for prostate cancer.I cannot have MRI contrast due to severe kidney issues, sickle cell, anemia, or allergies.I do not have any severe health or mental conditions that could affect my participation.I am a man aged between 45 and 80.My prostate cancer has a Gleason score of 3+4.My cancer is in an early stage and has not grown deeply.My prostate cancer has a Gleason score of 7 or less.My prostate is smaller than 90 cc according to my latest MRI.I have not had any cancer except for skin or low-grade bladder cancer in the last 2 years.I am currently experiencing visible blood in my urine that has not been treated.I am considered fit for general anesthesia.My prostate is small enough based on recent MRI measurements.I have had surgery to remove part of my prostate.I have leg pain when walking or Leriches Syndrome.I have severe bladder control issues due to nerve problems.I have been diagnosed with Parkinson's disease or multiple sclerosis.You have a history of using drugs in a harmful or dangerous way.I do not have HIV, AIDS, hepatitis B, or hepatitis C.I have swelling in one or both of my kidneys due to urine buildup.I am not allergic to Glucagon (in the USA) or Buscopan (in Canada and Europe).I have had major surgery or radiation therapy in my rectal or pelvic area.I have diabetes with complications or my Hemoglobin A1c is over 7%.I have bladder stones that have not been treated.I currently have an untreated UTI.My prostate cancer was confirmed by a biopsy taken between 6 weeks and 6 months ago.My prostate cancer has a Gleason score of 3+4.I am on blood thinners, but they can be stopped temporarily for treatment.I am interested in having children in the future.
Research Study Groups:
This trial has the following groups:- Group 1: MRI-guided Transurethral Ultrasound Ablation Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age criterion for this research study include people aged below 50?
"This trial has an age mandate of 45 to 80 years old, as specified by the inclusionary requirements."
Answered by AI
Are there any vacancies for participants in this research?
"Affirmative. According to the data available on clinicaltrials.gov, this medical research began recruiting participants on September 21st 2016 and is still looking for volunteers today. 150 individuals need to be enrolled at two sites in total."
Answered by AI
What is the population size of individuals who have been included in this research?
"Affirmative. According to the information posted on clinicaltrials.gov, this research study is actively recruiting participants and has been since September 21st 2016. 150 people are required from 2 different sites and the trial was recently updated on September 12th 2022."
Answered by AI
What results is the clinical trial designed to achieve?
"The primary objective of this clinical trial, assessed over a one-year period, is to ascertain the proportion of patients achieving a Prostate Specific Antigen (PSA) nadir below 25% relative to their pre-treatment baseline. Secondary outcomes include Erection Firmness Endpoint - which evaluates rate of achievement for firmness sufficient for penetration via International Index of Erectile Function (IIEF), IPSS Endpoint - measuring change in International Prostate Symptom Score before and after treatment, as well as Prostate Biopsy Endpoint - assessing negative prostate biopsies at 12 months post-intervention using transrectal"
Answered by AI
Do I satisfy the criteria to join this medical experiment?
"This clinical trial, now recruiting, is designed to accept 150 males aged 45-80 with prostate cancer at a stage ≤ T2b. Moreover, subjects must have either a Gleason score 3+4 (Part I) or 4+3 (Part II)."
Answered by AI
Who else is applying?
What state do they live in?
Hawaii
Illinois
How old are they?
65+
What site did they apply to?
University of California Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- University of California Los Angeles: < 24 hours
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