Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
MRI-guided Transurethral Ultrasound Ablation (MRI-TULSA) technology was developed at Sunnybrook Research Institute (Toronto, Canada), after several years of research and testing. Early feasibility testing in humans was conducted at Sunnybrook Research Institute by Dr. Laurence Klotz. In two separate studies, a total of twelve patients who were scheduled for prostatectomy volunteered for the MRI-TULSA prostate ablation procedure prior to their surgery. After the surgery, their prostate was removed and tested (histology) to confirm that prostate tissues were ablated as planned. The results showed that MRI-TULSA can precisely ablate prostate tissue [Chopra et. al. Radiology 2012, Volume 265, Number 1, pages 303-313].
Profound Medical Inc. has licensed exclusively the MRI-TULSA technology from Sunnybrook Research Institute and is developing it into a medical device named the TULSA-PRO. Recently, 30 patients went through this procedure in a Phase I clinical trial in the United States, Canada, and Germany. The purpose of the study was to assess safety of the TULSA-PRO system. All patients underwent the prostate ablation procedure and the study end points were met. The Phase I trial demonstrated that the TULSA-PRO system is safe and feasible and further study in a larger patient population is justified. The purpose of this study is to obtain information on the safety and effectiveness of the TULSA-PRO system. The system is designed to destroy prostate tissue under Magnetic Resonance Imaging (MRI) guidance using ultrasound energy. This device is not approved for clinical use except within this investigational study.
Adult men who have been diagnosed with prostate cancer. For more information about the eligibility criteria for this trial, refer to the Health Professional version.
- 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
- 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.
- 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
- 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
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- UCLA Westwood