| Primary | Number of Device and Procedure Related Adverse Events | The cumulative sum of adverse events was followed through Month 12 of the study. | Adverse Events and Serious Adverse Events are reported in the Adverse Events Section. | Posted | | Number | | Number of Adverse Events | | 12 months Post Treatment | | | | ID | Title | Description |
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| OG000 | Exablate MR Guided Focus Ultrasound | Exablate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance guided focused ultrasound energy |
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| Primary | Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months. | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Subjects | | 6 Months Post Treatment | | | | ID | Title | Description |
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| OG000 | Exablate MR Guided Focused Ultrasound | Exablate MR Guided Focused Ultrasound for the local treatment of prostate lesions using Magnetic Resonance guided focused ultrasound energy |
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| Primary | Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months | 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) | | Posted | | Number | 95% Confidence Interval | Percentage of Subjects | | 6-months Post Treatment | | | | ID | Title | Description |
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| OG000 | Exablate MR Guided Focus Ultrasound | Exablate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance guided focused ultrasound energy |
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| Primary | Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at 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. | | Posted | | Number | 95% Confidence Interval | Percentage of Subjects | | 6 Months Post Treatment | | | | ID | Title | Description |
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| OG000 | Exablate MR Guided Focus Ultrasound | Exablate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance guided focused ultrasound energy |
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| Secondary | Prostate Specific Antigen (PSA) | 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. | | Posted | | Mean | Standard Deviation | ng/mL | | Baseline, 6 Months, 12 Months | | | | ID | Title | Description |
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| OG000 | Exablate MR Guided Focus Ultrasound | Exablate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance guided focused ultrasound energy |
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| Secondary | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 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. | Deviations across visits resulted from missed visits and missed assessments. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessents subjects were separated into two subgroups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment (n=44). There was no hypothesis test comparison between groups. Comparisons are only observational. Deviations from the Overall Number of Participants is a result of missed visits, assessments and early exits. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessents subjects were separated into two subgroups after the treatment (not randomly: 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment (n=44). There was no hypothesis test comparison between groups. Comparisons are only observational. Deviations from the Overall Number of Participants is a result of missed visits, assessments and early exits. |
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| Secondary | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 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. | Deviations from in the number of participants result from missed visits, assessments and early exits. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. Deviations from the Overall Number of Participants is a result of missed visits, assessments and early exits. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. Deviations from the Overall Number of Participants is a result of missed visits, assessments and early exits. |
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| Secondary | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 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. | Deviations in sample size across visits are due to subjects missing visits, missing assessments, or exiting the study. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment). There was no hypothesis test comparison. Comparisons are only observational. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. |
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| Secondary | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 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. | Deviations from the overall number of participants are a result of missed visits, missed incomplete assessments, and early study exits | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessments subjects were separated into groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. |
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| Secondary | International Prostate Symptom Score (IPSS Total Score) | 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. | Deviations from the Overall Number of Participants Analyzed resulted from missed visits, missed assessments or early study exits. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessments subjects were separated into twe groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. |
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| Secondary | International Prostate Symptom Score (IPSS) - Quality of Life Score | 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. | Deviations from the overall number of participants result from missed visits, missed assessments, and early study exits. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. |
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| Secondary | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | IIEF-15 Erectile Dysfunction Overall Satisfaction (IIEF-15 Overall Satisfaction range: 0-10). Low scores are worse. | Deviations from the Overall Number of Participants Analyzed results from missed visits, missed or incomplete assessments, or early study exits. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, 3 Months, 6 Months, 9 Months, 12 Months. | | | | ID | Title | Description |
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| OG000 | Neurovascular Bundles and/or Urethra Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) This group, neurovascular bundles and/or urethra included in treatment (n=57) or 2) Neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. | | OG001 | Neurovascular Bundles and Urethra Not Included in Treatment | For patient self-completed assessments subjects were separated into two groups after the treatment (not randomly): 1) Neurovascular bundles and/or urethra included in treatment (n=57) or 2) This group, neurovascular bundles and urethra NOT included in treatment. There was no hypothesis test comparison. Comparisons are only observational. | | OG002 | Total Exablate MR Guided Focus Ultrasound |
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