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

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ClinicalTrials.gov Identifier: NCT02766543
Recruitment Status : Active, not recruiting
First Posted : May 9, 2016
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Profound Medical Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MRI-guided Transurethral Ultrasound Ablation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI-guided Transurethral Ultrasound Ablation Device
Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue.
Device: MRI-guided Transurethral Ultrasound Ablation
Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
Other Name: TULSA-PRO




Primary Outcome Measures :
  1. Safety Endpoint - Incidence of treatment-emergent adverse events [ Time Frame: 1 year ]
    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).

  2. Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value. [ Time Frame: 1 year ]
    Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.


Secondary Outcome Measures :
  1. Erectile Dysfunction Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with IIEF-5 < 17.

  2. Erection Firmness Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Rate of erection firmness sufficient for penetration, determined by the change from baseline of the proportion of patients with IIEF item 2 ≥ 2.

  3. Urinary Incontinence Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Rate of urinary incontinence, determined by the change from baseline of the proportion of patients with EPIC item 5 ≥ 1 (one or more pads per day).

  4. PSA Nadir Endpoint [ Time Frame: 1 year ]
    Proportion of patients achieving PSA nadir ≤ 0.5 ng/ml.

  5. PSA Stability Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Proportion of patients with PSA ≤ 0.5 ng/ml at the most recent follow-up visit.

  6. Prostate Volume Endpoint [ Time Frame: 1 year ]
    Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits.

  7. Prostate Biopsy Endpoint [ Time Frame: 1 year ]
    Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by transrectal ultrasound-guided 10-core biopsy.

  8. IPSS Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit.

  9. IIEF Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Change in the Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction domains of the International Index of Erectile Function (IIEF-15), between the baseline and most recent follow-up visit.

  10. EPIC Endpoint [ Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years). ]
    Change in Urinary, Bowel, Sexual and Hormonal domains of the Expanded Prostate Cancer Index Composite (EPIC), between the baseline and most recent follow-up visit.

  11. Targeting Accuracy Endpoint [ Time Frame: During treatment ]
    Conformal prostate ablation, measured quantitatively between the target prostate volume and the target temperature isotherm on MRI thermometry acquired during the TULSA-PRO procedure, and described using three measures of targeting accuracy (Dice Similarity Coefficient; Over- and under-targeted volumes; Linear targeting in mm).

  12. CE-MRI Endpoint [ Time Frame: Immediately after treatment ]
    Conformal prostate ablation, assessed qualitatively by visualizing the peripheral region of enhancement surrounding the non-perfused volume (NPV) on contrast-enhanced (CE)-MRI acquired immediately after treatment.

  13. mpMRI Endpoint [ Time Frame: 1 year ]
    Characterize the effect of the TULSA-PRO ablation on diagnostic multi-parametric prostate MRI (mpMRI), determined using PI-RADS v2 performed at the Baseline and 12-month follow-up visits.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766543


Locations
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21231
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9105
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6C 2R5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Germany
University Hospital of Cologne
Cologne, Germany, 50937
Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)
Heidelberg, Germany, 69120
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6500
Spain
ResoFus Alomar (Hospital Universitari De Bellvitge)
Barcelona, Spain, 08029
Sponsors and Collaborators
Profound Medical Inc.
Investigators
Principal Investigator: Scott Eggener, MD University of Chicago

Responsible Party: Profound Medical Inc.
ClinicalTrials.gov Identifier: NCT02766543     History of Changes
Other Study ID Numbers: GCP-10100
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Profound Medical Inc.:
prostate cancer
high intensity transurethral ultrasound ablation
MRI-guided
minimally invasive
real-time temperature feedback control

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases