Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01686958|
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : October 25, 2018
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: MR-Guided Transurethral US Ablation of Prostate Tissue||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 13, 2013|
|Actual Primary Completion Date :||March 23, 2015|
|Actual Study Completion Date :||June 11, 2019|
Experimental: MR-Guided Transurethral US Ablation
MR-Guided Transurethral US Ablation of Prostate Tissue
Device: 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 prostate tissue.
Other Name: Prostate Ablation Device: PAD-105
- 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.
- 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 ]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.
- Treatment Efficacy - Biopsy [ Time Frame: 12 months from the Treatment Date ]Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.
- Treatment Efficacy - PSA [ 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 ]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.
- Treatment Efficacy - Quality of Life - Urinary Symptoms [ Time Frame: Baseline and 12-months post Treatment ]
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
- Treatment Efficacy - Quality of Life - Erectile Function [ Time Frame: Baseline and 12-months post Treatment ]
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
- Treatment Efficacy - Quality of Life - Bowel Habits [ Time Frame: Baseline and 12-months post Treatment ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686958
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|London Health Science Centre|
|London, Ontario, Canada, N6A 5W9|
|German Cancer Research Center (DKFZ)|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Joseph Chin, MD||London Health Science Center|
|Principal Investigator:||James Relle, MD||William Beaumont Hospitals|
|Principal Investigator:||Ryan Berglund, MD||The Cleveland Clinic|
|Principal Investigator:||Heinz P Schlemmer, MD||German Cancer Research Center|