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

Prior treatment

• 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.
• Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
• Patients with artificial urinary sphincter or any penile implant
• Any prostate related investigational therapy within 6 months of Visit 1

Other illness

• Acute unresolved Urinary Tract Infection (UTI)
• 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
• 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)
• 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
• History of acute urinary retention within the last 12 months
• 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
• 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

Lab values

• 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.
• Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c \> 7%.
• 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

Other

• 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
• Prostate calcifications \> 1 cm in largest diameter, on Baseline Ultrasound
• Cysts \> 1 cm in largest diameter, on Baseline MRI
• Interest in future fertility
• Severe neurogenic bladder
• Untreated bladder stones
• 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
• Current unilateral or bilateral hydronephrosis

• 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
  • 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.