Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Profound Medical Inc.
ClinicalTrials.gov Identifier:
NCT01686958
First received: September 13, 2012
Last updated: August 19, 2014
Last verified: March 2014
  Purpose

This study is to evaluate that the MRI-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Device: MR-Guided Transurethral US Ablation of Prostate Tissue
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study: A Prospective, Multi-center, Single Arm Study - Evaluation of the Safety and Feasibility of MRI-guided Transurethral Ultrasound Therapy for the Ablation of Prostate Tissue in Patients With Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Profound Medical Inc.:

Primary Outcome Measures:
  • Evaluate the frequency and severity of device / treatment related adverse events associated with the use of the investigational system to coagulate prostate tissue. [ Time Frame: 12 months from the Treatment Date ] [ Designated as safety issue: Yes ]
    Severity of adverse events per patient will be evaluated and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).


Secondary Outcome Measures:
  • Evaluate the effectiveness of the investigation system to thermally coagulate prostate tissue conforming to the target volume with a high degree of accuracy and precision. [ Time Frame: 12 months from the Treatment Date ] [ Designated as safety issue: No ]

    • Conformal thermal coagulation of prostate tissue will be determined quantitatively using two measures of targeting accuracy: i. Dice Similarity Coefficient (DSC - unitless from 0 to 1), is a statistical validation metric to measure the degree of spatial overlap between two regions.

    ii. Over- and under-targeted volumes (outside the target volume ± ½ voxel margin), representing the amount of tissue ≥ target temperature (55°C) outside the target volume and < target temperature (55°C) inside the target volume, respectively. The over- and under-targeted volumes are expressed as a % of the target volume.

    • Coagulation of prostate tissue will be confirmed by measurement of the peripheral region of enhancement surrounding the Non-Perfused Volume (NPV) determined from Contrast-Enhanced MR images (CE-MRI) acquired immediately after treatment and at 12 months after treatment.



Other Outcome Measures:
  • In addition to patient safety and treatment feasibility, initial efficacy of using the investigation system to achieve adequate tumor control for their localized prostate cancer will also be evaluated. [ Time Frame: 12 months from the treatment date ] [ Designated as safety issue: No ]
    • Evaluate the initial effectiveness of the treatment to achieve disease control at 6 months based on biopsy results.
    • Characterize the pattern of PSA response in the first 12 months following treatment.
    • Evaluate quality of life using the UCLA-PCI-SF & SF-12 v2, IPSS and IIEF standardized questionnaires in the first 12 months following treatment.


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-Guided Transurethral US Ablation
MR-Guided Transurethral US Ablation of Prostate Tissue
Device: MR-Guided Transurethral US Ablation of Prostate Tissue
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
Other Name: Prostate Ablation Device: PAD-105

Detailed Description:

Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system. 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 completely within an 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, thereby reducing the risk of possible damage to important surrounding anatomy such as the rectum, urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method, therefore, has the potential to have lower complication rates than conventional therapies.

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, age ≥65
  • Patient with low-risk, early-stage organ-confined prostate cancer (Stage T1c or T2a, N0, M0).
  • Gleason score 6 (3+3)
  • PSA ≤ 10 ng/ml
  • Eligible for MR imaging (DOC-10252)
  • Meets the following criteria on pre-treatment transrectal ultrasound imaging:

    1. No cysts or calcifications > 1.0 cm in size
    2. No evidence of extraprostatic extension or seminal vesicle invasion
    3. Overall prostate size less than 5 cm in sagittal length and less than 7 cm in diameter
  • Biopsy confirmed adenocarcinoma of the prostate, performed at least 6 weeks prior to and no more than 6 months prior to the scheduled treatment.
  • Eligible for General Anesthesia, as defined in American Society of Anesthesiologists (ASA)
  • Normal rectal anatomy and rectal mucosa on digital rectal examination

Exclusion Criteria:

  • Bleeding disorder
  • Abnormal coagulation and current anticoagulant therapy.
  • Acute or chronic Urinary Tract Infection
  • Interest in future fertility
  • History of allergy relevant medication or other
  • History of any other malignancy other than skin cancer
  • Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
  • Prior treatment of the prostate gland
  • Prior treatment with 5 alpha reductase inhibitor allowed (not as prostate cancer treatment or prevention) as long as drug has been stopped for minimum 3 months
  • History of any major rectal or pelvic surgery
  • History of ulcerative colitis or other chronic inflammatory conditions affecting rectum
  • History of documented clinical prostatitis requiring therapy within previous 6 months
  • History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae which had required prior urethrotomy, urethral stenting, urethroplasty or chronic indwelling urethral catheter
  • Patients with artificial urinary sphincter or any penile implant (metallic or non-metallic)
  • Neurologic bladder disorders
  • Untreated bladder stones
  • History of acute urinary retention
  • Confirmed or suspected bladder cancer
  • Urinary sphincter abnormalities
  • 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

Additional exclusion criteria on file....

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686958

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Canada, Ontario
London Health Science Centre
London, Ontario, Canada, N6A 5W9
Germany
German Cancer Research Center (DKFZ)
Heidelberg, Germany, 69120
Sponsors and Collaborators
Profound Medical Inc.
Investigators
Principal Investigator: Joseph Chin, MD London Health Science Center
Principal Investigator: James Relle, MD William Beaumont Hospitals
Principal Investigator: Rayan Berglund, MD The Cleveland Clinic
Principal Investigator: Heinz P Schlemmer, MD German Cancer Research Center
  More Information

No publications provided

Responsible Party: Profound Medical Inc.
ClinicalTrials.gov Identifier: NCT01686958     History of Changes
Other Study ID Numbers: PMI-10246
Study First Received: September 13, 2012
Last Updated: August 19, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 22, 2014