Clinical Trials /

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

NCT02766543

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: GCP-10100
  • NCT ID: NCT02766543

Conditions

  • Prostate Cancer

Purpose

A prospective, multi-center, single-arm study, planned in 110 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.

Detailed Description

      Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral
      ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ
      confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation
      of prostate tissue.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
MRI-Guided TULSA-PRO deviceExperimentalMagnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue.

    Eligibility Criteria

            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 [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
    
            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:
    
                   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
          
    Maximum Eligible Age:80 Years
    Minimum Eligible Age:45 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of treatment-emergent adverse events
    Time Frame:1 year
    Safety Issue:
    Description:Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).

    Secondary Outcome Measures

    Measure:Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
    Time Frame:1 year
    Safety Issue:
    Description:Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Profound Medical Inc.

    Trial Keywords

    • prostate cancer
    • high intensity transurethral ultrasound ablation
    • MRI-guided
    • minimally invasive
    • real-time temperature feedback control

    Last Updated

    February 3, 2017