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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02766543

Sponsor: Profound Medical Inc.

Eligibility:

  • Age: minimum 45 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  1. Male, age 45 to 80 years
  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.
  3. Clinical stage ≤ T2b
  4. Gleason score ≤ 3 + 4
  5. PSA ≤ 15 ng/ml
  6. Eligible for MRI
  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 Exclusion Criteria:
  11. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
  12. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
  13. Prior definitive treatment of prostate cancer
  14. Prior transurethral resection of the prostate (TURP)
  15. 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.
  16. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
  17. Cysts > 1 cm in largest diameter, on Baseline MRI
  18. Bleeding disorder (INR > ULN and PTT > ULN)
  19. 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:

  1. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
  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)
  9. 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.
  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:
  32. Patients in the USA: Glucagon
  33. Patients in Canada and Europe: Buscopan (Hyoscine)
  34. 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
  35. 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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