Outcomes of Focal Ablation for Prostate Cancer

Study Overview
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Brief Summary
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This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

Detailed Description
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This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment. There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems. These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU). This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Official Title
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Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease Age 18-90 years. Life expectancy > 1 year Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Anatomic abnormalities that do not allow for focal ablation Evidence of non-organ confined disease that is not feasible for ablation Has active urinary traction infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ablative Therapy Group<br>Enrolled subjects will undergo the ablative therapy as part of their standard of care treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focal ablation