Prostate CancerNCT01686958
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
A study testing MR-Guided Transurethral US Ablation of Prostate Tissue in people with Prostate Cancer, run by Profound Medical Inc. at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MR-Guided Transurethral US Ablation of Prostate Tissue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 13 Mar 2013to 11 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Show all 23Show fewer
- 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....
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- MR-Guided Transurethral US Ablation of Prostate Tissue
- Keywords
- Prostate Cancer, High intensity transurethral ultrasound ablation, MRI-guided, Minimally invasive, Real-time temperature feedback control
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Guided Transurethral US Ablation of Prostate TissueDevice
Also called Prostate Ablation Device: PAD-105
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
| Study group | Role | What they receive |
|---|---|---|
| MR-Guided Transurethral US Ablation | Experimental | MR-Guided Transurethral US Ablation of Prostate Tissue Receives: Device: MR-Guided Transurethral US Ablation of Prostate Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: On Treatment Date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start13 Mar 2013
- Primary completion23 Mar 2015
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profound Medical Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Chin, MD, Principal investigator, London Health Science CenterJames Relle, MD, Principal investigator, Corewell Health EastRyan Berglund, MD, Principal investigator, The Cleveland ClinicHeinz P Schlemmer, MD, Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686958
- Sponsor's protocol ID
- DOC-10246
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2012
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 26777228
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01686958
- Acronym / sponsor ID
- DOC-10246
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, High intensity transurethral ultrasound ablation, MRI-guided, Minimally invasive, Real-time temperature feedback control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Profound Medical Inc.University, hospital or other
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- 23 Mar 2015 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 25 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-Guided Transurethral US Ablation | Experimental | Device: MR-Guided Transurethral US Ablation of Prostate TissueMR-Guided Transurethral US Ablation of Prostate Tissue |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-Guided Transurethral US Ablation of Prostate TissueAlso: Prostate Ablation Device: PAD-105The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue. | Device | MR-Guided Transurethral US Ablation |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26777228Chin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Chin, MD principal investigator
London Health Science Center
James Relle, MD principal investigator
Corewell Health East
Ryan Berglund, MD principal investigator
The Cleveland Clinic
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-Guided Transurethral US Ablation of Prostate Tissue in people with Prostate Cancer, run by Profound Medical Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Evaluate the Frequency of Treatment Related Adverse Events (time frame: 12 months from the Treatment Date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.