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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MR-Guided Transurethral US Ablation of Prostate Tissue

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, High intensity transurethral ultrasound ablation, MRI-guided, Minimally invasive, Real-time temperature feedback control

Eligibility Criteria

65 Years - 75 Years (Older Adult)MaleDoes not accept healthy volunteers

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....

Sites / Locations

William Beaumont Hospital
London Health Science Centre
German Cancer Research Center (DKFZ)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR-Guided Transurethral US Ablation

Arm Description

MR-Guided Transurethral US Ablation of Prostate Tissue

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01686958

First Posted

September 13, 2012

Last Updated

January 29, 2020

Sponsor

Profound Medical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01686958

Brief Title

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

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

March 13, 2013 (Actual)

Primary Completion Date

March 23, 2015 (Actual)

Study Completion Date

June 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Profound Medical Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR-Guided Transurethral US Ablation

Arm Type

Experimental

Arm Description

MR-Guided Transurethral US Ablation of Prostate Tissue

Intervention Type

Device

Intervention Name(s)

MR-Guided Transurethral US Ablation of Prostate Tissue

Other Intervention Name(s)

Prostate Ablation Device: PAD-105

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety - Evaluate the Frequency of Treatment Related Adverse Events

Description

Time Frame

12 months from the Treatment Date

Title

Safety - Evaluate the Severity of Treatment Related Adverse Events

Description

Time Frame

12 months from the Treatment Date

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

On Treatment Date

Other Pre-specified Outcome Measures:

Title

Treatment Efficacy - Biopsy

Description

Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.

Time Frame

12 months from the Treatment Date

Title

Treatment Efficacy - PSA

Description

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.

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

Title

Treatment Efficacy - Quality of Life - Urinary Symptoms

Description

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

Time Frame

Baseline and 12-months post Treatment

Title

Treatment Efficacy - Quality of Life - Erectile Function

Description

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

Time Frame

Baseline and 12-months post Treatment

Title

Treatment Efficacy - Quality of Life - Bowel Habits

Description

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

Time Frame

Baseline and 12-months post Treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: 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 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....

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Chin, MD

Organizational Affiliation

London Health Science Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James Relle, MD

Organizational Affiliation

William Beaumont Hospitals

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ryan Berglund, MD

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heinz P Schlemmer, MD

Organizational Affiliation

German Cancer Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

London Health Science Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

German Cancer Research Center (DKFZ)

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26777228

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.

Results Reference

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

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