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

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ClinicalTrials.gov Identifier: NCT01686958
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : October 25, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Profound Medical Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Device: MR-Guided Transurethral US Ablation of Prostate Tissue
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
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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.

Period Title: Overall Study
Started 30
Completed 29 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
No. of patients who completed ALL assessments at 12 months post treatment; 1 pt only had PSA test.
Arm/Group Title MR-Guided Transurethral US Ablation
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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.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Baseline measures were only done for the patients who passed screening and eligibility criteria
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
   6.7%
>=65 years
28
  93.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
0
   0.0%
Male
30
 100.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Multi-racial
1
   3.3%
White/Caucasian
29
  96.7%
[1]
Measure Description: 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.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Canada 12
United States 4
Germany 14
Subjects with erections sufficient for penetration at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
21
  70.0%
[1]
Measure Description: 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.
1.Primary Outcome
Title Safety - Evaluate the Frequency of Treatment Related Adverse Events
Hide Description 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.
Time Frame 12 months from the Treatment Date
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Comments A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.
Type of Statistical Test Other
Comments This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.
Other Statistical Analysis For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.
2.Primary Outcome
Title Safety - Evaluate the Severity of Treatment Related Adverse Events
Hide Description

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.

Time Frame 12 months from the Treatment Date
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects
Hematuria - G1
43
(25 to 63)
Hematuria - G2
6.7
(0.8 to 22)
Urinary tract infection - G2
33
(17 to 53)
Epididymitis - G3
3.3
(0.1 to 17)
Urinary retention - G1
10
(2.1 to 27)
Urinary retention - G2
17
(5.6 to 35)
Obstructive micturition
10
(2.1 to 27)
Urinary incontinence - G1
3.3
(0.1 to 17)
Urinary incontinence - G2
10
(2.1 to 27)
Urinary stricture - G1
3.3
(0.1 to 17)
Urinary stricture - G2
3.3
(0.1 to 17)
3.Secondary Outcome
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
Hide Description 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.
Time Frame On Treatment Date
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: mm
Thermal ablation accuracy 0.1  (0.4)
Thermal ablation precision 1.3  (0.4)
4.Other Pre-specified Outcome
Title Treatment Efficacy - Biopsy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Positive biopsy (clinically significant disease)
9
  31.0%
Overall absence of clinically significant disease
20
  69.0%
5.Other Pre-specified Outcome
Title Treatment Efficacy - PSA
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: ng/ml
PSA @ Baseline
5.8
(3.8 to 8.0)
PSA @ 1 month
0.8
(0.5 to 1.1)
PSA @ 3 months
0.9
(0.4 to 1.7)
PSA @ 6 months
0.8
(0.4 to 1.1)
PSA @ 12 months
0.8
(0.6 to 1.1)
6.Other Pre-specified Outcome
Title Treatment Efficacy - Quality of Life - Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
IPSS @ Baseline Number Analyzed 30 participants
8
(5 to 13)
IPSS @ 12 months Number Analyzed 29 participants
5
(4 to 7)
7.Other Pre-specified Outcome
Title Treatment Efficacy - Quality of Life - Erectile Function
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
IIEF-EF-15 @ Baseline Number Analyzed 30 participants
13
(6 to 28)
IIEF-EF-15 @ 12 months Number Analyzed 29 participants
13
(5 to 25)
8.Other Pre-specified Outcome
Title Treatment Efficacy - Quality of Life - Bowel Habits
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MR-Guided Transurethral Ultrasound of Prostate Tissue Ablation
Hide Arm/Group Description:

The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.

Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.

Overall Number of Participants Analyzed 30
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
UCLA-PCI-SF-BH @ Baseline Number Analyzed 30 participants
100
(90 to 100)
UCLA-PCI-SF-BH @ 12 months Number Analyzed 29 participants
100
(100 to 100)
Time Frame 12 months
Adverse Event Reporting Description 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).
 
Arm/Group Title MR-Guided Transurethral US Ablation
Hide Arm/Group Description

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.

All-Cause Mortality
MR-Guided Transurethral US Ablation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MR-Guided Transurethral US Ablation
Affected / at Risk (%)
Total   2/30 (6.67%) 
Infections and infestations   
Epididymitis * [1]  1/30 (3.33%) 
Renal and urinary disorders   
Urinary retention * [2]  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
[1]
Patient diagnosed with epididymitis on left side, requiring antibiotics. Shortly thereafter patient developed a fever requiring hospital admission with changes to prescribed antibiotics.
[2]
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.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MR-Guided Transurethral US Ablation
Affected / at Risk (%)
Total   30/30 (100.00%) 
Gastrointestinal disorders   
Rectal pain *  1/30 (3.33%) 
Fecal straining *  1/30 (3.33%) 
Bloating *  3/30 (10.00%) 
General disorders   
Distended abdomen *  1/30 (3.33%) 
Ear drainage *  1/30 (3.33%) 
Fatigue *  1/30 (3.33%) 
Hematoma or Ecchymosis: Buttock *  1/30 (3.33%) 
Hemtoma or Ecchymosis: Femur *  1/30 (3.33%) 
Hematoma or Ecchymosis: Sacral bone *  1/30 (3.33%) 
Hyperkalemia *  1/30 (3.33%) 
Patient movement at onset of treatment *  1/30 (3.33%) 
Raised lump: Back *  1/30 (3.33%) 
Sore throat *  1/30 (3.33%) 
Pain: Back, hips, shoulder, upon catheter removal *  5/30 (16.67%) 
Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out *  5/30 (16.67%) 
Infections and infestations   
Epididymitis *  1/30 (3.33%) 
Fever *  1/30 (3.33%) 
Renal and urinary disorders   
Hematuria *  15/30 (50.00%) 
Urinary tract infection *  10/30 (33.33%) 
Urinary retention *  8/30 (26.67%) 
Urinary incontinence *  4/30 (13.33%) 
Urinary stricture *  2/30 (6.67%) 
Bladder inflammation *  1/30 (3.33%) 
Bladder irritability *  1/30 (3.33%) 
Bladder spasm *  5/30 (16.67%) 
Edema: penile and/or scrotal *  5/30 (16.67%) 
Edema: testicular *  1/30 (3.33%) 
Hemorrhagic cystitis *  1/30 (3.33%) 
Increased post void urinary residual in bladder *  2/30 (6.67%) 
Nocturia *  2/30 (6.67%) 
Obstructive micturition *  3/30 (10.00%) 
Penile discharge or bleeding *  10/30 (33.33%) 
Prostate anatomical change or discoloration *  7/30 (23.33%) 
Prostate inflammation *  1/30 (3.33%) 
Prostate tissue sloughing *  1/30 (3.33%) 
Scarred urethra *  1/30 (3.33%) 
Urethral skin tags *  1/30 (3.33%) 
Urinary frequency *  10/30 (33.33%) 
Urinary hesitancy *  7/30 (23.33%) 
Urinary sensation to void *  1/30 (3.33%) 
Urinary urgency *  12/30 (40.00%) 
Urine abnormality *  2/30 (6.67%) 
Dysuria *  6/30 (20.00%) 
Pain: Bladder, penile, perineal, prostate, urethral *  12/30 (40.00%) 
Reproductive system and breast disorders   
Erectile dysfunction or worsening erectile function *  11/30 (36.67%) 
Ejaculation disorder *  7/30 (23.33%) 
Hematospermia *  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Radmila Blank, Clinical Trials Manager
Organization: Profound Medical
Phone: 647-476-1350 ext 440
EMail: rblank@profoundmedical.com
Layout table for additonal information
Responsible Party: Profound Medical Inc.
ClinicalTrials.gov Identifier: NCT01686958     History of Changes
Other Study ID Numbers: DOC-10246
First Submitted: September 13, 2012
First Posted: September 18, 2012
Results First Submitted: August 28, 2018
Results First Posted: October 25, 2018
Last Update Posted: June 26, 2019