Clinical trial NCT01686958: Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
High intensity transurethral ultrasound ablation
MRI-guided
Minimally invasive
Real-time temperature feedback control
Lead sponsor: Profound Medical Inc.
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 30
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)
* 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....

Primary outcomes:
measure: Safety - Evaluate the Frequency of Treatment Related Adverse Events
timeFrame: 12 months from the Treatment Date
measure: Safety - Evaluate the Severity of Treatment Related Adverse Events
timeFrame: 12 months from the Treatment Date
Secondary outcomes:
measure: 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
timeFrame: On Treatment Date
Other outcomes:
measure: Treatment Efficacy - Biopsy
timeFrame: 12 months from the Treatment Date
measure: Treatment Efficacy - PSA
timeFrame: As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline
measure: Treatment Efficacy - Quality of Life - Urinary Symptoms
timeFrame: Baseline and 12-months post Treatment
measure: Treatment Efficacy - Quality of Life - Erectile Function
timeFrame: Baseline and 12-months post Treatment
measure: Treatment Efficacy - Quality of Life - Bowel Habits
timeFrame: Baseline and 12-months post Treatment
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Heidelberg
country: Germany
facility: German Cancer Research Center (DKFZ)
Study officials:
affiliation: London Health Science Center
name: Joseph Chin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospitals
name: James Relle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Ryan Berglund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Cancer Research Center
name: Heinz P Schlemmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.