Trial Outcomes & Findings for Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions (NCT NCT01657942)

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.

Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

The cumulative sum of adverse events was followed through Month 12 of the study.

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.

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)

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.

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.

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.

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 - 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.

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.

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.

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.

IIEF-15 Erectile Dysfunction Overall Satisfaction (IIEF-15 Overall Satisfaction range: 0-10). Low scores are worse.