Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
- Conditions
- Localized Intermediate Risk Prostate Lesions
- Interventions
- Device: ExAblate MR Guided Focused Ultrasound
- Registration Number
- NCT01657942
- Lead Sponsor
- InSightec
- Brief Summary
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
- Detailed Description
Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.
ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.
Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 101
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ExABlate MR Guided Focus Ultrasound ExAblate MR Guided Focused Ultrasound ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
- Primary Outcome Measures
Name Time Method Number of Device and Procedure Related Adverse Events 12 months Post Treatment The cumulative sum of adverse events was followed through Month 12 of the study.
Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months. 6 Months Post Treatment The first primary effectiveness endpoint is within area of treatment (Region of Treatment, ROT) prostate biopsy occurring at 6-months post-treatment. Positive biopsy was defined as any Gleason Grade Group (GGG) tissue identified within the area of planned Exablate ROT. Negative biopsy was defined No Gleason Grade Group (GGG) tissue within the area of planned ROT.
Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months 6-months Post Treatment The second primary effectiveness endpoint is the percentage of subjects experiencing a reduction in PSA value (Prostate Specific Antigen) from baseline to 6-months post-treatment. PSA values that increased or remained the same were considered an increase. Increased Prostate Specific Antigen levels in the blood is a common indication of prostate cancer.
PSA results at 6 months - Value of ≤ 10ng/mL (Yes/No)Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment. 6 Months Post Treatment The final primary effectiveness endpoint is percentage of subjects with NPV complete coverage of targeted Gleason tissue at treatment. NPV (non-perfused volume) is the volume of tissue ablated/treated, a measure of the completeness/effectiveness of the ablation.
- Secondary Outcome Measures
Name Time Method Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) Baseline, 3 Months, 6 Months, 9 Months, 12 Months. Functional Assessment of Cancer Therapy - P (Fact-P) Trial Outcomes Index (TOI, Score range: 1-104). An alternative scoring method to the Fact-G Total is the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, and Lung Cancer Subscales. The TOI is reported to be an efficient and precise summary index of physical and functional outcomes. Higher scores indicate less symptomology and better physical and functional outcomes.
International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score Baseline, 3 Months, 6 Months, 9 Months, 12 Months. Urinary incontinence (ICIQ) Total Score (Score range: 0-21) is a simple questionnaire for evaluating the frequency, severity, and impact of urinary incontinence. High scores indicate greater impairment. Lower scores indicate better outcomes. This questionnaire assesses urinary incontinence and its impact on quality of life (QoL). So, a lower score implies less frequent and less severe incontinence, which is generally considered favorable.
International Prostate Symptom Score (IPSS Total Score) Baseline, 3 Months, 6 Months, 9 Months, 12 Months. High scores indicate worse symptomology. The total I-PSS score can range from 0 (asymptomatic) to 35 (very symptomatic). Additionally, there's a question about quality of life due to urinary symptoms, where patients rate their feelings from "delighted" to "terrible" regarding their current condition. This assessment helps clinicians understand the severity of BPH symptoms and guide treatment decisions.
International Prostate Symptom Score (IPSS) - Quality of Life Score Baseline, 3 Months, 6 Months, 9 Months, 12 Months. IPSS Urinary Symptoms (IPSS-QoL Score range: 0-5). Question 7 of the IPSS, the Quality-of-Life question, is "7. Nocturia: How many times do you typically get up at night to urinate? (Select from 0 to 5)." Zero (0) suggests no interference with sleep and 5 suggests greater interference with sleep. Thus, high scores indicate worse quality of life.
International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction Baseline, 3 Months, 6 Months, 9 Months, 12 Months. IIEF-15 Erectile Dysfunction Overall Satisfaction (IIEF-15 Overall Satisfaction range: 0-10). Low scores are worse.
Prostate Specific Antigen (PSA) Baseline, 6 Months, 12 Months Prostate Specific Antigen (PSA) concentration in the blood is commonly measured to screen for prostate cancer. Prostate Specific Antigen (PSA) was reported as a primary endpoint. Here it is presented to show levels at 6 Months and 12 Months post-treatment compared to Baseline (pre-treatment). Elevated PSA suggests potential cancer.
Functional Assessment of Cancer Therapy - General (Fact-G) Total Score Baseline, 3 Months, 6 Months, 9 Months, 12 Months. The total FACT-G score ranges from 0 to 108 and is the summation of 4 subscale scores. The subscale scores are added to obtain the total score, which is calculated using a five-point scale from 0 (not at all) to 4 (very much). A higher FACT-G score indicates better overall well-being and quality of life. The FACT-G is an alternative scoring method to the Trial Outcome Index (TOI) which is also reported in this study.
Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score Baseline, 3 Months, 6 Months, 9 Months, 12 Months The Fact-P Total Score (Score range: 0-156) is a comprehensive multidimensional quality of life measure designed specifically for patients with prostate cancer. It is a 39-item assessment in a 5-point (0-4) Likert-type Scale. Higher scores represent better symptomology, functioning and quality of life.
Trial Locations
- Locations (9)
Weill Cornell Medical Center
🇺🇸New York, New York, United States
City of Hope
🇺🇸Duarte, California, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Sperling Prostate Center
🇺🇸Delray Beach, Florida, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States