Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) |
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (= 3 mm of Gleason = 6 disease in any biopsy core is insignificant) |
12 months post treatment |
|
| Primary |
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) |
Oncologic outcomes will be assessed by the rate of advancement to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy. |
3 years post treatment |
|
| Primary |
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) |
Oncologic outcomes will be assessed by the rate of negative in-field biopsy at 12 months which is defined by the Delphi consensus criterion of absence of clinically significant disease (= 3 mm of Gleason = 6 disease in any biopsy core is insignificant) |
12 months post treatment |
|
| Primary |
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting) |
Oncologic outcomes will be assessed by the rate of progression to systemic therapy or radical salvage therapies which is defined by prostatectomy, radiation or hormone therapy. |
3 years post treatment |
|
| Primary |
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting) |
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change > 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome). |
Baseline and 12 months post treatment |
|
| Primary |
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting) |
Change in urinary function is measured by International Prostate Symptom Score (IPSS) questionnaire which measures urinary symptoms and continence and the scores range from 0 to 35. A change > 3 points between baseline and follow-up assessments is defined as meaningful for the IPSS. Therefore, increases in IPSS scores larger than 3 points will be categorized as reduced urinary function (worse outcome). |
Baseline and 12 months post treatment |
|
| Primary |
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting) |
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function. |
Baseline and 12 months post treatment |
|
| Primary |
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting) |
Change in erectile function is measured by International Index of Erectile Function (IIEF-5) score questionnaire which classifies patients into five severity levels ranging from none (22-25 points) to severe (5-7 points). Patients whose IIEF-5 levels worsen from baseline to follow-up will be categorized as having reduced erectile function. |
Baseline and 12 months post treatment |
|
| Secondary |
Number of participants with adverse events or short-term complications (primary setting) |
Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment |
30 days post treatment |
|
| Secondary |
Number of participants with adverse events or short-term complications (salvage setting) |
Adverse events (AE)s will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for 30 days post-treatment |
30 days post treatment |
|
| Secondary |
Number of participants with adverse events or long-term complications (primary setting) |
An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment |
3 years post-treatment |
|
| Secondary |
Number of participants with adverse events or long-term complications (salvage setting) |
An adverse event (AE) will be monitored and evaluated by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for up to 3 years post-treatment |
3 years post-treatment |
|
| Secondary |
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH) |
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by BPH will be evaluated to determine efficacy of treatment of the transitional zone in patients with LUTS due to BPH via International Prostate Symptom Score (IPSS) questionnaire |
Baseline and 12 months post treatment |
|
