Localized Intermediate Risk Prostate Lesions
Conditions
Keywords
MRgFUS, Prostate, Intermediate Risk Prostate Lesions, Focal Prostate treatment, InSightec, ExAblate, Non-invasive, Prostate cancer, Gleason 7
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).
Interventions
DEVICEExAblate MR Guided Focused Ultrasound
ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment * Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy. * Patient with PSA less than or equal to 20 ng/mL * Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core * Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI
Exclusion criteria
* Contraindications to MRI * History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy * Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors) * Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time) * Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.) * Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging * Bladder cancer * Urethral stricture/bladder neck contracture * Prostatitis NIH categories I, II and III * Implant near (\<1 cm) the prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
The study was multi-center, prospective, single arm, observational trial conducted in the United States where subjects were treated and followed for 12 months. Males over 50 years of age (median age of 63 years) with a single, MRI-visible, hemilateral lesion of biopsy proven Gleason Grade Group 2 (3+4) or 3 (4+3) adenocarcinoma and with a PSA less than or equal to 20 ng/mL were treated with the Exablate 2100 Prostate System.
Participants by arm
| Arm | Count |
|---|---|
| Exablate MR Guided Focus Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions Exablate MR Guided Focused Ultrasound for the local treatment of intermediate prostate lesions using Magnetic Resonance guided focused ultrasound energy. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Alternative Treatment | 7 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Exablate MR Guided Focus Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions |
|---|---|
| Age, Continuous Age | 62.9 Years STANDARD_DEVIATION 6.7 |
| Biopsy proven adenocarcinoma of the prostate | 101 Participants |
| BMI [kg/m^2] | 28.5 kg/m^2 STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 101 Participants |
| Weight [kg] | 91.3 kg STANDARD_DEVIATION 17.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 24 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Number of Device and Procedure Related Adverse Events
The cumulative sum of adverse events was followed through Month 12 of the study.
Time frame: 12 months Post Treatment
Population: Adverse Events and Serious Adverse Events are reported in the Adverse Events Section.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exablate MR Guided Focus Ultrasound | Number of Device and Procedure Related Adverse Events | 24 Number of Adverse Events |
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)
Time frame: 6-months Post Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exablate MR Guided Focus Ultrasound | Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months | 91.1 Percentage of Subjects |
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.
Time frame: 6 Months Post Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exablate MR Guided Focus Ultrasound | Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months. | 91.1 Percentage of Subjects |
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.
Time frame: 6 Months Post Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exablate MR Guided Focus Ultrasound | Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment. | 87.1 Percentage of Subjects |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations across visits resulted from missed visits and missed assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 9 Months | 97.3 score on a scale | Standard Deviation 7.7 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 6 Months | 64.0 score on a scale | Standard Deviation 10.8 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | Baseline | 94.8 score on a scale | Standard Deviation 10.8 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 3 Months | 95.7 score on a scale | Standard Deviation 8.5 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 12 Months | 95.3 score on a scale | Standard Deviation 10.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 6 Months | 92.5 score on a scale | Standard Deviation 11 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | Baseline | 94.5 score on a scale | Standard Deviation 8.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 3 Months | 90.2 score on a scale | Standard Deviation 12.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 9 Months | 92.3 score on a scale | Standard Deviation 10.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 12 Months | 93.3 score on a scale | Standard Deviation 10.5 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 12 Months | 94.4 score on a scale | Standard Deviation 10.7 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 9 Months | 95.1 score on a scale | Standard Deviation 9.4 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | Baseline | 94.7 score on a scale | Standard Deviation 9.9 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 6 Months | 93.4 score on a scale | Standard Deviation 10.9 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - General (Fact-G) Total Score | 3 Months | 93.3 score on a scale | Standard Deviation 10.9 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Population: Deviations from in the number of participants result from missed visits, assessments and early exits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 12 Months | 134.6 score on a scale | Standard Deviation 14.9 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 9 Months | 136.6 score on a scale | Standard Deviation 12.5 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 3 Months | 134.3 score on a scale | Standard Deviation 13.2 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 6 Months | 132.4 score on a scale | Standard Deviation 15.8 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | Baseline | 134.2 score on a scale | Standard Deviation 15.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 9 Months | 129.2 score on a scale | Standard Deviation 14.5 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 3 Months | 127.8 score on a scale | Standard Deviation 16.3 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 6 Months | 130.5 score on a scale | Standard Deviation 12.9 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 12 Months | 130.7 score on a scale | Standard Deviation 13 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | Baseline | 134.3 score on a scale | Standard Deviation 11.6 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | Baseline | 134.2 score on a scale | Standard Deviation 14 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 12 Months | 132.9 score on a scale | Standard Deviation 14.2 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 3 Months | 131.4 score on a scale | Standard Deviation 14.9 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 9 Months | 137.7 score on a scale | Standard Deviation 13.4 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score | 6 Months | 131.6 score on a scale | Standard Deviation 14.6 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations in sample size across visits are due to subjects missing visits, missing assessments, or exiting the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 9 Months | 90.5 score on a scale | Standard Deviation 9.8 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 6 Months | 88.8 score on a scale | Standard Deviation 11.4 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | Baseline | 89.9 score on a scale | Standard Deviation 10.5 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 3 Months | 89.1 score on a scale | Standard Deviation 10.2 |
| Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 12 Months | 89.9 score on a scale | Standard Deviation 9.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 6 Months | 86.9 score on a scale | Standard Deviation 9.1 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | Baseline | 90.8 score on a scale | Standard Deviation 7.6 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 3 Months | 86.0 score on a scale | Standard Deviation 10.2 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 9 Months | 86.4 score on a scale | Standard Deviation 9.5 |
| Neurovascular Bundles and Urethra Not Included in Treatment | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 12 Months | 87.7 score on a scale | Standard Deviation 8 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 12 Months | 88.9 score on a scale | Standard Deviation 9 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 9 Months | 88.7 score on a scale | Standard Deviation 9.9 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | Baseline | 90.3 score on a scale | Standard Deviation 9.3 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 6 Months | 88.0 score on a scale | Standard Deviation 10.4 |
| Total Exablate MR Guided Focus Ultrasound | Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI) | 3 Months | 87.7 score on a scale | Standard Deviation 10.3 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations from the overall number of participants are a result of missed visits, missed incomplete assessments, and early study exits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 9 Months | 2.0 score on a scale | Standard Deviation 2.6 |
| Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 6 Months | 2.2 score on a scale | Standard Deviation 3.1 |
| Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | Baseline | 1.2 score on a scale | Standard Deviation 2.2 |
| Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 3 Months | 2.0 score on a scale | Standard Deviation 3 |
| Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 12 Months | 2.0 score on a scale | Standard Deviation 2.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 6 Months | 2.0 score on a scale | Standard Deviation 2.6 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | Baseline | 1.5 score on a scale | Standard Deviation 2.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 3 Months | 2.2 score on a scale | Standard Deviation 2.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 9 Months | 2.1 score on a scale | Standard Deviation 2.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 12 Months | 1.8 score on a scale | Standard Deviation 2.4 |
| Total Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 12 Months | 1.9 score on a scale | Standard Deviation 2.6 |
| Total Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 9 Months | 2.0 score on a scale | Standard Deviation 2.6 |
| Total Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | Baseline | 1.3 score on a scale | Standard Deviation 2.5 |
| Total Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 6 Months | 2.1 score on a scale | Standard Deviation 2.9 |
| Total Exablate MR Guided Focus Ultrasound | International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score | 3 Months | 2.1 score on a scale | Standard Deviation 2.9 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations from the Overall Number of Participants Analyzed results from missed visits, missed or incomplete assessments, or early study exits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 9 Months | 6.9 score on a scale | Standard Deviation 2.4 |
| Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 6 Months | 7.0 score on a scale | Standard Deviation 2.7 |
| Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | Baseline | 7.8 score on a scale | Standard Deviation 2.3 |
| Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 3 Months | 6.8 score on a scale | Standard Deviation 2.7 |
| Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 12 Months | 6.9 score on a scale | Standard Deviation 2.5 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 6 Months | 6.9 score on a scale | Standard Deviation 2.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | Baseline | 7.0 score on a scale | Standard Deviation 2.7 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 3 Months | 6.5 score on a scale | Standard Deviation 2.5 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 9 Months | 6.7 score on a scale | Standard Deviation 2.5 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 12 Months | 7.3 score on a scale | Standard Deviation 2.4 |
| Total Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 12 Months | 7.1 score on a scale | Standard Deviation 2.5 |
| Total Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 9 Months | 6.8 score on a scale | Standard Deviation 2.4 |
| Total Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | Baseline | 7.4 score on a scale | Standard Deviation 2.5 |
| Total Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 6 Months | 7.0 score on a scale | Standard Deviation 2.7 |
| Total Exablate MR Guided Focus Ultrasound | International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction | 3 Months | 6.7 score on a scale | Standard Deviation 2.6 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations from the overall number of participants result from missed visits, missed assessments, and early study exits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 9 Months | 1.1 score on a scale | Standard Deviation 1.1 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 6 Months | 1.2 score on a scale | Standard Deviation 1.1 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | Baseline | 1.9 score on a scale | Standard Deviation 1.5 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 3 Months | 1.2 score on a scale | Standard Deviation 1.2 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 12 Months | 1.1 score on a scale | Standard Deviation 1 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS) - Quality of Life Score | 6 Months | 1.3 score on a scale | Standard Deviation 1 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS) - Quality of Life Score | Baseline | 1.6 score on a scale | Standard Deviation 1.2 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS) - Quality of Life Score | 3 Months | 1.5 score on a scale | Standard Deviation 1.2 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS) - Quality of Life Score | 9 Months | 1.4 score on a scale | Standard Deviation 1 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS) - Quality of Life Score | 12 Months | 1.4 score on a scale | Standard Deviation 1 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 12 Months | 1.2 score on a scale | Standard Deviation 1 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 9 Months | 1.2 score on a scale | Standard Deviation 1.1 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | Baseline | 1.8 score on a scale | Standard Deviation 1.4 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 6 Months | 1.2 score on a scale | Standard Deviation 1.1 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS) - Quality of Life Score | 3 Months | 1.3 score on a scale | Standard Deviation 1.2 |
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.
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months.
Population: Deviations from the Overall Number of Participants Analyzed resulted from missed visits, missed assessments or early study exits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 9 Months | 7.5 score on a scale | Standard Deviation 5.6 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 6 Months | 7.5 score on a scale | Standard Deviation 6.5 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | Baseline | 8.5 score on a scale | Standard Deviation 6.4 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 3 Months | 8.1 score on a scale | Standard Deviation 6.5 |
| Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 12 Months | 7.6 score on a scale | Standard Deviation 5.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS Total Score) | 6 Months | 8.4 score on a scale | Standard Deviation 5.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS Total Score) | Baseline | 8.8 score on a scale | Standard Deviation 6 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS Total Score) | 3 Months | 8.1 score on a scale | Standard Deviation 5.2 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS Total Score) | 9 Months | 8.4 score on a scale | Standard Deviation 5.8 |
| Neurovascular Bundles and Urethra Not Included in Treatment | International Prostate Symptom Score (IPSS Total Score) | 12 Months | 8.9 score on a scale | Standard Deviation 6.4 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 12 Months | 8.2 score on a scale | Standard Deviation 6.1 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 9 Months | 8.2 score on a scale | Standard Deviation 6 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | Baseline | 8.6 score on a scale | Standard Deviation 6.2 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 6 Months | 7.9 score on a scale | Standard Deviation 6.2 |
| Total Exablate MR Guided Focus Ultrasound | International Prostate Symptom Score (IPSS Total Score) | 3 Months | 8.1 score on a scale | Standard Deviation 6 |
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.
Time frame: Baseline, 6 Months, 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exablate MR Guided Focus Ultrasound | Prostate Specific Antigen (PSA) | Baseline | 6.4 ng/mL | Standard Deviation 3.1 |
| Exablate MR Guided Focus Ultrasound | Prostate Specific Antigen (PSA) | 6 Months | 3.3 ng/mL | Standard Deviation 2.9 |
| Exablate MR Guided Focus Ultrasound | Prostate Specific Antigen (PSA) | 12 Months | 3.2 ng/mL | Standard Deviation 2.5 |