We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified October 2017 by Profound Medical Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02766543
First Posted: May 9, 2016
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Profound Medical Inc.
  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.

Condition Intervention Phase
Prostate Cancer Device: MRI-guided Transurethral Ultrasound Ablation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Profound Medical Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Rate of erectile dysfunction through Quality of Life questionnaire [ 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.

  • Rate of erection firmness through Quality of Life questionnaire [ 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.

  • Rate of urinary incontinence through Quality of Life questionnaire [ 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).

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

  • Proportion of patients with stable PSA levels [ 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.

  • Level of prostate reduction [ Time Frame: 1 year ]
    Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits.

  • Proportion of patients with negative biopsy [ 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.

  • Change in international prostate symptom score using a Quality of Life questionnaire. [ 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.

  • Change in erectile and orgasmic function, sexual desire and intercourse satisfaction using a Quality of Life questionnaire. [ 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.

  • Change in urinary, bowel, sexual and hormonal domains using a Quality of Life questionnaire. [ 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.

  • Qualitative assessment of prostate ablation through visualization from MRI [ 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.

  • Characterization of the effect of the transurethral ultrasound ablation device from MRI data values [ 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.


Estimated Enrollment: 110
Actual Study Start Date: September 21, 2016
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MRI-Guided TULSA-PRO device
Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue.
Device: MRI-guided Transurethral Ultrasound Ablation
Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Goldy Singh 647.476.1350 ext 403 gsingh@profoundmedical.com

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Tammy Floore, BSN    310-481-7510    tfloore@mednet.ucla.edu   
Principal Investigator: Steve Raman, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ambereen Yousuf, MD    773-702-6003    ayousuf@radiology.bsd.uchicago.edu   
Contact: Pamela Carter, RN    773-702-2537    pcarter@radiology.bsd.uchicago.edu   
Principal Investigator: Aytekin Oto, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Courtney Dhondt, RN    317-274-1791    cgerler@ie.edu   
Principal Investigator: Michael Koch, MD         
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Tanya O'Neal, RN, BSN, MSN    410-955-9797    Toneal2@jhmi.edu   
Contact: Sandra Moore-Cooper    410-955-0009    mooresa@jhmi.edu   
Principal Investigator: Christian Pavlovich, MD         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Maureen Cooney, RN    248-551-9477    maureen.cooney@beaumont.org   
Principal Investigator: James Relle, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Pam Steele, RN    615-343-2120    pamela.steele@vanderbilt.edu   
Principal Investigator: David Penson, MD         
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9105
Contact: Allison Beaver, BSN, RN    214-645-8787    allison.beaver@utsouthwestern.edu   
Principal Investigator: Yair Lotan, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6C 2R5
Contact: Wendy Shoff, RN    519-685-8500 ext 57350    Wendy.Shoff@lhsc.on.ca   
Principal Investigator: Joseph Chin, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian    416-480-6100 ext 2890    marlene.kebabdjian@sunnybrook.ca   
Principal Investigator: Laurence Klotz, MD         
Germany
University Hospital of Cologne Recruiting
Cologne, Germany, 50937
Contact: Study Coordination, Study Center Urology    +49-(0)221-478-82113    urologie-studienkoordination@uk-koeln.de   
Principal Investigator: Thorsten Persigehl, Dr. med.         
Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology) Recruiting
Heidelberg, Germany, 69120
Contact: Urologische Klinik    06221/56-8820      
Principal Investigator: Gencay Hatiboglu, Dr.         
Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6500
Contact: Annemarijke van Luijtelaar       annemarijke.vanluijtelaar@radboudumc.nl   
Principal Investigator: Jurgen J Futterer, Prof. Dr.         
Spain
Clinica Universidad de Navarra Withdrawn
Pamplona, Navarra, Spain, 31008
ResoFus Alomar (Hospital Universitari De Bellvitge) Recruiting
Barcelona, Spain, 08029
Contact: Alberto Alomar       alberto@centremedicalomar.es   
Principal Investigator: Jose Francisco Suarez Novo, MD         
Sponsors and Collaborators
Profound Medical Inc.
Investigators
Principal Investigator: Scott Eggener, MD University of Chicago
  More Information

Responsible Party: Profound Medical Inc.
ClinicalTrials.gov Identifier: NCT02766543     History of Changes
Other Study ID Numbers: GCP-10100
First Submitted: May 5, 2016
First Posted: May 9, 2016
Last Update Posted: October 17, 2017
Last Verified: October 2017
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