Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02766543

Run by

Profound Medical Inc.

People needed

150

Starts

2016-09-21

Expected to finish

2028-09-30

Last updated by the study team

2025-08-17

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 1 Gleason score ≤ 3 + 4 (Part I only)
• 2 Gleason score 3+4 (Part II only) *now recruiting
• PSA ≤ 15 ng/ml
• Eligible for MRI [Form GCP-10131]
• Eligible for general anesthesia (ASA category ≤ 3)
• Prostate volume ≤ 90 cc, on Baseline MRI
• Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
• Life expectancy ≥ 10 years
• No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.

You may not qualify if…

• 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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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