Prostate CancerTACTNCT02766543
Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
A study testing MRI-guided Transurethral Ultrasound Ablation in people with Prostate Cancer, run by Profound Medical Inc. at 14 sites in 5 countries.
Trial summary
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI-guided Transurethral Ultrasound Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 21 Sep 2016to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age 45 to 80 years
- Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
- Clinical stage ≤ T2b
- 4.1 Gleason score ≤ 3 + 4 (Part I only)
- 4.2 Gleason score 3+4 (Part II only) now recruiting
- 5. PSA ≤ 15 ng/ml
Show all 12Show fewer
- 6. Eligible for MRI [Form GCP-10131]
- 7. Eligible for general anesthesia (ASA category ≤ 3)
- 8. Prostate volume ≤ 90 cc, on Baseline MRI
- 9. Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
- 10. Life expectancy ≥ 10 years
- 11. No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.
Who cannot join
- Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
- Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
- Prior definitive treatment of prostate cancer
- Prior transurethral resection of the prostate (TURP)
- Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
- Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
Show all 35Show fewer
- Cysts > 1 cm in largest diameter, on Baseline MRI
- Bleeding disorder (INR > ULN and PTT > ULN)
- Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
- Acute unresolved Urinary Tract Infection (UTI)
- Interest in future fertility
- History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
- Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
- Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
- History of any major rectal or pelvic surgery or radiotherapy
- History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
- Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
- History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
- Patients with artificial urinary sphincter or any penile implant
- Severe neurogenic bladder
- Untreated bladder stones
- History of acute urinary retention within the last 12 months
- Active untreated gross hematuria for any cause
- Post Void Residual (PVR) bladder volume > 250 mL
- Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI
- Any prostate related investigational therapy within 6 months of Visit 1
- History of Parkinson's disease or multiple sclerosis
- History of drug abuse
- Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
- Current unilateral or bilateral hydronephrosis
- Allergy or contraindications to administration of the GI anti-spasmodic drug:
- Patients in the USA: Glucagon
- Patients in Canada and Europe: Buscopan (Hyoscine)
- Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
- Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States8 sites
Johns Hopkins Medicine
Baltimore, Maryland, 21231
University of Chicago
Chicago, Illinois, 60637
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9105
Indiana University
Indianapolis, Indiana, 46202
University of California Los Angeles
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale Cancer Centre
New Haven, Connecticut, 06520-8058
William Beaumont Hospital
Royal Oak, Michigan, 48073
Canada2 sites
London Health Sciences Centre
London, Ontario, N6C 2R5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Germany2 sites
University Hospital of Cologne
Cologne, 50937
Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)
Heidelberg, 69120
Spain1 site
ResoFus Alomar (Hospital Universitari De Bellvitge)
Barcelona, 08029
About this study
Official title: Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Read the detailed description
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland.
It provides advantages of a non-invasive procedure with short treatment times.
- Conditions
- Prostate Cancer
- Being tested
- MRI-guided Transurethral Ultrasound Ablation
- Keywords
- prostate cancer, high intensity transurethral ultrasound ablation, MRI-guided, minimally invasive, real-time temperature feedback control, whole-gland, TULSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided Transurethral Ultrasound AblationDevice
Also called TULSA-PRO
Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided Transurethral Ultrasound Ablation Device | Experimental | Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue. Receives: Device: MRI-guided Transurethral Ultrasound Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint - Incidence of treatment-emergent adverse events
Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Measured: 1 year
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Measured: 1 year
Secondary outcomes (13)
Erectile Dysfunction Endpoint
Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with IIEF-5 < 17.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Erection Firmness Endpoint
Rate of erection firmness sufficient for penetration, determined by the change from baseline of the proportion of patients with IIEF item 2 ≥ 2.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Urinary Incontinence Endpoint
Rate of urinary incontinence, determined by the change from baseline of the proportion of patients with EPIC item 5 ≥ 1 (one or more pads per day).
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
PSA Nadir Endpoint
Proportion of patients achieving PSA nadir ≤ 0.5 ng/ml.
Measured: 1 year
PSA Stability Endpoint
Proportion of patients with PSA ≤ 0.5 ng/ml at the most recent follow-up visit.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Prostate Volume Endpoint
Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits.
Measured: 1 year
Prostate Biopsy Endpoint
Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by transrectal ultrasound-guided 10-core biopsy.
Measured: 1 year
IPSS Endpoint
Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
IIEF Endpoint
Change in the Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction domains of the International Index of Erectile Function (IIEF-15), between the baseline and most recent follow-up visit.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
EPIC Endpoint
Change in Urinary, Bowel, Sexual and Hormonal domains of the Expanded Prostate Cancer Index Composite (EPIC), between the baseline and most recent follow-up visit.
Measured: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Targeting Accuracy Endpoint
Conformal prostate ablation, measured quantitatively between the target prostate volume and the target temperature isotherm on MRI thermometry acquired during the TULSA-PRO procedure, and described using three measures of targeting accuracy (Dice Similarity Coefficient; Over- and under-targeted volumes; Linear targeting in mm).
Measured: During treatment
CE-MRI Endpoint
Conformal prostate ablation, assessed qualitatively by visualizing the peripheral region of enhancement surrounding the non-perfused volume (NPV) on contrast-enhanced (CE)-MRI acquired immediately after treatment.
Measured: Immediately after treatment
mpMRI Endpoint
Characterize the effect of the TULSA-PRO ablation on diagnostic multi-parametric prostate MRI (mpMRI), determined using PI-RADS v2 performed at the Baseline and 12-month follow-up visits.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start21 Sep 2016
- Primary completion28 Feb 2019
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profound Medical Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Eggener, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766543
- Sponsor's protocol ID
- GCP-10100
- Acronym
- TACT
- Status last verified
- Aug 2025
- First submitted
- 5 May 2016
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wright C, Makela P, Bigot A, Anttinen M, Bostrom PJ, Blanco Sequeiros R. Deep learning prediction of non-perfused volume without contrast agents during prostate ablation therapy. Biomed Eng Lett. 2022 Nov 8;13(1):31-40. doi: 10.1007/s13534-022-00250-y. eCollection 2023 Feb.
PubMed 36711157
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
- ClinicalTrials.gov ID
- NCT02766543
- Acronym / sponsor ID
- TACT / GCP-10100
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, high intensity transurethral ultrasound ablation, MRI-guided, minimally invasive, real-time temperature feedback control, whole-gland, TULSA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Profound Medical Inc.University, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Detailed description
Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland.
It provides advantages of a non-invasive procedure with short treatment times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided Transurethral Ultrasound Ablation Device | Experimental | Device: MRI-guided Transurethral Ultrasound AblationMagnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male, age 45 to 80 years
- Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
- Clinical stage ≤ T2b
- 4.1 Gleason score ≤ 3 + 4 (Part I only)
- 4.2 Gleason score 3+4 (Part II only) now recruiting
Key exclusion criteria (35 listed)
- Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
- Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
- Prior definitive treatment of prostate cancer
- Prior transurethral resection of the prostate (TURP)
- Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-guided Transurethral Ultrasound AblationAlso: TULSA-PROMagnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation. | Device | MRI-guided Transurethral Ultrasound Ablation Device |
Primary outcome
Safety Endpoint - Incidence of treatment-emergent adverse events
Time frame: 1 year
Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
Time frame: 1 year
Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
13 secondary outcomes
Erectile Dysfunction Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Erection Firmness Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Urinary Incontinence Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
PSA Nadir Endpoint
Time frame: 1 year
PSA Stability Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Prostate Volume Endpoint
Time frame: 1 year
Prostate Biopsy Endpoint
Time frame: 1 year
IPSS Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
IIEF Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
EPIC Endpoint
Time frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
Targeting Accuracy Endpoint
Time frame: During treatment
CE-MRI Endpoint
Time frame: Immediately after treatment
mpMRI Endpoint
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 36711157Wright C, Makela P, Bigot A, Anttinen M, Bostrom PJ, Blanco Sequeiros R. Deep learning prediction of non-perfused volume without contrast agents during prostate ablation therapy. Biomed Eng Lett. 2022 Nov 8;13(1):31-40. doi: 10.1007/s13534-022-00250-y. eCollection 2023 Feb.
- FDA 510k SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Eggener, MD principal investigator
University of Chicago
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI-guided Transurethral Ultrasound Ablation in people with Prostate Cancer, run by Profound Medical Inc. at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada, Germany, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint - Incidence of treatment-emergent adverse events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.