Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
NCT ID: NCT02766543
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2016-09-21
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
NCT01686958
Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer
NCT03814252
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
NCT04808427
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
NCT05438563
Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy
NCT02790216
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MRI-guided Transurethral Ultrasound Ablation Device
Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.
MRI-guided Transurethral Ultrasound Ablation
Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI-guided Transurethral Ultrasound Ablation
Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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).
3. 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
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.
Exclusion Criteria
2. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
3. Prior definitive treatment of prostate cancer
4. Prior transurethral resection of the prostate (TURP)
5. 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.
6. Prostate calcifications \> 1 cm in largest diameter, on Baseline Ultrasound
7. Cysts \> 1 cm in largest diameter, on Baseline MRI
8. Bleeding disorder (INR \> ULN and PTT \> ULN)
10. Acute unresolved Urinary Tract Infection (UTI)
11. Interest in future fertility
12. 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.
13. Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
14. Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c \> 7%.
15. History of any major rectal or pelvic surgery or radiotherapy
16. History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
17. Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
18. 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
19. Patients with artificial urinary sphincter or any penile implant
20. Severe neurogenic bladder
21. Untreated bladder stones
22. History of acute urinary retention within the last 12 months
23. Active untreated gross hematuria for any cause
24. Post Void Residual (PVR) bladder volume \> 250 mL
25. 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
26. Any prostate related investigational therapy within 6 months of Visit 1
27. History of Parkinson's disease or multiple sclerosis
28. History of drug abuse
29. Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
30. Current unilateral or bilateral hydronephrosis
31. Allergy or contraindications to administration of the GI anti-spasmodic drug:
1. Patients in the USA: Glucagon
2. Patients in Canada and Europe: Buscopan (Hyoscine)
32. 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
33. 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
45 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Profound Medical Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Eggener, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California Los Angeles
Los Angeles, California, United States
Yale Cancer Centre
New Haven, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Hospital of Cologne
Cologne, , Germany
Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)
Heidelberg, , Germany
Radboud University Medical Center
Nijmegen, , Netherlands
ResoFus Alomar (Hospital Universitari De Bellvitge)
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
FDA 510k Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GCP-10100
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.