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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-Guided Transurethral US Ablation | Experimental | MR-Guided Transurethral US Ablation of Prostate Tissue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy - Biopsy | Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results. | 12 months from the Treatment Date |
| Treatment Efficacy - PSA | 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. |
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:
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:
Additional exclusion criteria on file....
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| London Health Science Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26777228 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue | Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation. Study is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment. Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline measures were only done for the patients who passed screening and eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | MR-Guided Transurethral US Ablation | MR-Guided Transurethral US Ablation of Prostate Tissue 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 prescribed prostate tissue. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device. | Posted | Count of Participants | Participants | 12 months from the Treatment Date |
|
12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MR-Guided Transurethral US Ablation | MR-Guided Transurethral US Ablation of Prostate Tissue 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 prescribed prostate tissue. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epididymitis | Infections and infestations | Non-systematic Assessment | Patient diagnosed with epididymitis on left side, requiring antibiotics. Shortly thereafter patient developed a fever requiring hospital admission with changes to prescribed antibiotics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mathieu Burtnyk | Profound Medical | 647-476-1350 | 408 | mburtnyk@profoundmedical.com |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| On Treatment Date |
| 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 | 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 | Baseline and 12-months post Treatment |
| Treatment Efficacy - Quality of Life - Erectile Function | 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 | Baseline and 12-months post Treatment |
| Treatment Efficacy - Quality of Life - Bowel Habits | 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 | Baseline and 12-months post Treatment |
| London |
| Ontario |
| N6A 5W9 |
| Canada |
| German Cancer Research Center (DKFZ) | Heidelberg | 69120 | Germany |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data was collected via a questionnaire completed by the patient at the Baseline Visit. Patients were asked to describe themselves by noting a "X" in one box only. Available options included; White/Caucasian; Black/African-American; Latino/Hispanic' Asian/Pacific Islander; Multi-Racial; Other. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subjects with erections sufficient for penetration at Baseline | Erectile dysfunction was defined as a score of 0-1 for Question 2 of the International Index of Erectile Function (IIEF-15). Patients with erections sufficient for penetration had a score greater than or equal to 2. | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device. | Posted | Mean | Standard Deviation | mm | On Treatment Date |
|
|
|
| Other Pre-specified | Treatment Efficacy - Biopsy | Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results. | One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis. | Posted | Count of Participants | Participants | 12 months from the Treatment Date |
|
|
|
| Other Pre-specified | Treatment Efficacy - PSA | 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. | Posted | Median | Inter-Quartile Range | ng/ml | As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline |
|
|
|
| Other Pre-specified | Treatment Efficacy - Quality of Life - Urinary Symptoms | 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 | One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12-months post Treatment |
|
|
|
| Other Pre-specified | Treatment Efficacy - Quality of Life - Erectile Function | 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 | One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12-months post Treatment |
|
|
|
| Other Pre-specified | Treatment Efficacy - Quality of Life - Bowel Habits | 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 | One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12-months post Treatment |
|
|
|
| Primary | 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. | The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device. | Posted | Number | 95% Confidence Interval | % of subjects | 12 months from the Treatment Date |
|
|
|
| 2 |
| 30 |
| 30 |
| 30 |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment | After removal of suprapubic catheter (SPC) as per protocol, the patient experienced retention and received an urethral catheter, but he continued experiencing retention, hence was hospitalized & required a second SPC. |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Epididymitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary stricture | Renal and urinary disorders | Non-systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fecal straining | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bladder inflammation | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder irritability | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | Non-systematic Assessment |
|
| Edema: penile and/or scrotal | Renal and urinary disorders | Non-systematic Assessment |
|
| Edema: testicular | Renal and urinary disorders | Non-systematic Assessment |
|
| Hemorrhagic cystitis | Renal and urinary disorders | Non-systematic Assessment |
|
| Increased post void urinary residual in bladder | Renal and urinary disorders | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Obstructive micturition | Renal and urinary disorders | Non-systematic Assessment |
|
| Penile discharge or bleeding | Renal and urinary disorders | Non-systematic Assessment |
|
| Prostate anatomical change or discoloration | Renal and urinary disorders | Non-systematic Assessment |
|
| Prostate inflammation | Renal and urinary disorders | Non-systematic Assessment |
|
| Prostate tissue sloughing | Renal and urinary disorders | Non-systematic Assessment |
|
| Scarred urethra | Renal and urinary disorders | Non-systematic Assessment |
|
| Urethral skin tags | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary hesitancy | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary sensation to void | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | Non-systematic Assessment |
|
| Erectile dysfunction or worsening erectile function | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hematospermia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Distended abdomen | General disorders | Non-systematic Assessment |
|
| Ear drainage | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Hematoma or Ecchymosis: Buttock | General disorders | Non-systematic Assessment |
|
| Hemtoma or Ecchymosis: Femur | General disorders | Non-systematic Assessment |
|
| Hematoma or Ecchymosis: Sacral bone | General disorders | Non-systematic Assessment |
|
| Hyperkalemia | General disorders | Non-systematic Assessment |
|
| Patient movement at onset of treatment | General disorders | Non-systematic Assessment |
|
| Raised lump: Back | General disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Pain: Back, hips, shoulder, upon catheter removal | General disorders | Non-systematic Assessment |
|
| Pain: Bladder, penile, perineal, prostate, urethral | Renal and urinary disorders | Non-systematic Assessment |
|
| Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out | General disorders | Non-systematic Assessment |
|
Sponsor will review the publication text within twenty days of receipt, however, Sponsor can request changes if text contains Sponsor's Confidential Information, or text contains information for which the Sponsor wishes to obtain patent protection, whereupon such information will be removed or there will be a delay to the presentation or publication to enable the Sponsor to proceed with patent application for an additional 60 days or until patent application has been filed, whichever is earlier.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| PSA @ 6 months |
|
| PSA @ 12 months |
|
|
|
|
| Title | Measurements |
|---|---|
|
| Epididymitis - G3 |
|
| Urinary retention - G1 |
|
| Urinary retention - G2 |
|
| Obstructive micturition |
|
| Urinary incontinence - G1 |
|
| Urinary incontinence - G2 |
|
| Urinary stricture - G1 |
|
| Urinary stricture - G2 |
|