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

NCT01686958 | Completed Results DMC

• 1 other identifier: DOC-10246
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; High intensity transurethral ultrasound ablation; MRI-guided; Minimally invasive; Real-time temperature feedback control

Outcome Measures

Primary Outcomes (2)

• Safety - Evaluate the Frequency of Treatment Related Adverse Events

  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.

  12 months from the Treatment Date

• Safety - Evaluate the Severity of Treatment Related Adverse Events

  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.

  12 months from the Treatment Date

Secondary Outcomes (1)

• 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

  On Treatment Date

Other Outcomes (5)

• Treatment Efficacy - Biopsy

  12 months from the Treatment Date

• Treatment Efficacy - PSA

  As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline

• Treatment Efficacy - Quality of Life - Urinary Symptoms

  Baseline and 12-months post Treatment

Study Arms (1)

MR-Guided Transurethral US Ablation

EXPERIMENTAL

MR-Guided Transurethral US Ablation of Prostate Tissue

Device: MR-Guided Transurethral US Ablation of Prostate Tissue

Interventions

MR-Guided Transurethral US Ablation of Prostate Tissue DEVICE

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.

Also known as: Prostate Ablation Device: PAD-105

MR-Guided Transurethral US Ablation

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• No cysts or calcifications \> 1.0 cm in size
• No evidence of extraprostatic extension or seminal vesicle invasion
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Profound Medical Inc.: lead

Study Sites (3)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

London Health Science Centre

London, Ontario, N6A 5W9, Canada

Location

German Cancer Research Center (DKFZ)

Heidelberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 26777228 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Mathieu Burtnyk
• Organization: Profound Medical

mburtnyk@profoundmedical.com

647-476-1350

Study Officials

• Joseph Chin, MD

  London Health Science Center

  PRINCIPAL INVESTIGATOR

• James Relle, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Ryan Berglund, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Heinz P Schlemmer, MD

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: March 13, 2013
• Primary Completion: March 23, 2015
• Study Completion: June 11, 2019
• Last Updated: February 11, 2020
• Results First Posted: October 25, 2018

Record last verified: 2020-01

Locations

CA (1); DE (1); US (1)