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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01686958
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : October 25, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Profound Medical Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2012
First Posted Date  ICMJE September 18, 2012
Results First Submitted Date  ICMJE August 28, 2018
Results First Posted Date  ICMJE October 25, 2018
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE March 13, 2013
Actual Primary Completion Date March 23, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
  • Safety - Evaluate the Frequency of Treatment Related Adverse Events [ Time Frame: 12 months from the Treatment Date ]
    All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.
  • Safety - Evaluate the Severity of Treatment Related Adverse Events [ Time Frame: 12 months from the Treatment Date ]
    Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI). There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
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: 6 months from the Treatment Date ]
Severity of adverse events per patient will be evaluated (from the treatment date to the 6 month follow-up date) and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
Change History Complete list of historical versions of study NCT01686958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2018)
Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision [ Time Frame: On Treatment Date ]
Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
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: 6 months from the Treatment Date ]
• 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 6 months after treatment.
Current Other Pre-specified Outcome Measures
 (submitted: October 24, 2018)
  • Treatment Efficacy - Biopsy [ Time Frame: 12 months from the Treatment Date ]
    Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.
  • Treatment Efficacy - PSA [ Time Frame: As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline ]
    Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.
  • Treatment Efficacy - Quality of Life - Urinary Symptoms [ Time Frame: Baseline and 12-months post Treatment ]
    Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms. Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic
  • Treatment Efficacy - Quality of Life - Erectile Function [ Time Frame: Baseline and 12-months post Treatment ]
    Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms. Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction
  • Treatment Efficacy - Quality of Life - Bowel Habits [ Time Frame: Baseline and 12-months post Treatment ]
    Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms. Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome
Original Other Pre-specified Outcome Measures
 (submitted: September 13, 2012)
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: 6 months from the treatment date ]
  • 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 6 months following treatment.
  • Evaluate quality of life using the UCLA-PCI-SF & SF-12 v2, IPSS and IIEF standardized questionnaires in the first 6 months following treatment.
 
Descriptive Information
Brief Title  ICMJE Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
Official Title  ICMJE 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
Brief Summary This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: MR-Guided Transurethral US Ablation
MR-Guided Transurethral US Ablation of Prostate Tissue
Intervention: Device: MR-Guided Transurethral US Ablation of Prostate Tissue
Publications * Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, Hatiboglu G, Mueller-Wolf MB, Motsch J, Romagnoli C, Kassam Z, Harle CC, Hafron J, Nandalur KR, Chronik BA, Burtnyk M, Schlemmer HP, Pahernik S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Eur Urol. 2016 Sep;70(3):447-55. doi: 10.1016/j.eururo.2015.12.029. Epub 2016 Jan 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 11, 2019
Actual Primary Completion Date March 23, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • Prostate-specific antigen (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....

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 65 Years to 75 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686958
Other Study ID Numbers  ICMJE DOC-10246
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Profound Medical Inc.
Study Sponsor  ICMJE Profound Medical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Chin, MD London Health Science Center
Principal Investigator: James Relle, MD William Beaumont Hospitals
Principal Investigator: Ryan Berglund, MD The Cleveland Clinic
Principal Investigator: Heinz P Schlemmer, MD German Cancer Research Center
PRS Account Profound Medical Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP