Customized TULSA-PRO Ablation Registry

Study Overview
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Brief Summary
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This patient registry will capture data from patients who have been or who are undergoing the transurethral ultrasound ablation (TULSA) procedure as part of their routine clinical care. The registry will shed light on real-world outcomes of safety and efficacy of the procedure and understand how a patient's quality of life is affected throughout their follow-up and lifetime.

Detailed Description
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This registry will capture data on patients undergoing customized transurethral ultrasound ablation (TULSA) as part of their routine clinical care. The aim of collecting such data is to further evaluate real-world outcomes of safety and efficacy of this treatment. The collection of this data is intended to form an evidence-base from which conclusions can be drawn on how to optimize outcomes to improve patient care and QOL, and further expand on knowledge of practice trends and treatment costs. The primary safety objective is to estimate the rate of complications attributable to the TULSA Procedure. The primary efficacy objective is estimating the proportion of patients who are free from primary treatment failure after the TULSA Procedure. Patients being offered TULSA Procedure will be invited to participate in the registry. Patients who have already undergone TULSA will also be allowed to join the registry. Hundreds to thousands of patients across sites in US, Canada and Europe will be followed as per routine clinical care at 3 months, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years and annually lifelong thereafter. Patients will remain active in the registry until they voluntarily withdraw or die. At each visit, patients will complete a set of questionnaires that is sent to them by email. Informed consent will be collected prior to enrolling the patient into the Registry. Initial baseline information will be collected (eg. demographics, medical history, concomitant medication, prostate MRI, prostate biopsy, PSA, and QOL Questionnaires) TULSA Procedure treatment assessment and complications will be collected from clinic records from treatment day. Optional financial tracking information may also be collected if patient consents to this portion of the registry. At follow-up visits, a set of data points will be collected (eg. PSA, complications, QoL Questionnaires, survival assessments, and optional financial tracking information) All Registry data will be collected and stored in an electronic database capture system called Castor. Castor is validated and compliant with all applicable laws and regulations, including ICH E6 GCP, 21 CFR Part 11, EU annex II, General Data Protection Regulation (GDPR), HIPAA (US), ISO 9001 and ISO 27001. Only sites and sponsor personnel will have access to the database. On site and/or remote study monitoring will be undertaken to check source documents and accuracy of data entry. All reasonable methods will be used to try to minimize missing data, however, some missing data is expected to occur. No interpolation of missing data will occur. Standard descriptive statistics, including the mean, standard deviation, median, range, proportion and frequency, will be used throughout to summarize results. Measures will be presented, and 95% confidence intervals will be constructed for selected measures, such as efficacy and safety. As a primarily descriptive study, analyses will be performed at the p=0.05 level of significance and exact analyses will be used wherever possible.

Official Title
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Customized TULSA-PRO Ablation Registry

Conditions
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Prostate Cancer, Prostate Adenocarcinoma, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: TULSA Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male >18 years old Candidate for TULSA-PRO treatment willing and able to sign the Informed Consent form Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Device: TULSA Procedure|Transurethral ultrasound ablation procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | estimating the rate of complications (Clavien-Dindo grades III - IV) attributable to the TULSA Procedure | 5 years | 
| Freedom from treatment failure | Estimating the proportion of patients who are free from primary treatment failure after the TULSA Procedure. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications Data | complications arising from TULSA-PRO treatment, categorized based on the type of corrective therapy needed using the Clavien-Dindo classification system | Lifelong up to 99 years | 
| Biopsy Data | in men with prostate cancer, biopsy data to assess if there are changes to either cancer or clinically significant cancer in the treatment region. | Between 6 and 18 months post TULSA Procedure | 
| Prostate Volume Reduction on MRI | Multi-parametric prostate MRI data to measure prostate volume reduction | Between 6 and 18 months post TULSA Procedure | 
| Suspicious cancerous lesions on MRI | Identify presence of any suspicious (i.e. suspected for cancer) lesions. | Between 6 and 18 months post TULSA Procedure | 
| PSA Data | PSA data to identify changes in PSA from baseline. | Lifelong up to 99 years | 
| QoL (IIEF-5) Data-Evaluation of Erectile Dysfunction, Ejaculatory function and erection firmness | Patient-reported qualify of life (QoL) questionnaire answers to assess changes in erectile dysfunction, ejaculatory function and erection firmness: IIEF-5 (International Index of Erectile Function) Minimum score=5, Maximum score=25. Lower scores indicate a worse outcome. | Lifelong up to 99 years | 
| QoL (IIEF-15) Data-Evaluation of Erectile Dysfunction, Ejaculatory function and erection firmness | Patient-reported qualify of life (QoL) questionnaire answers to assess changes in erectile dysfunction, ejaculatory function and erection firmness. 2 questions from IIEF-15 (International Index of Erectile Function) Low scores indicate a worse outcome. | Lifelong up to 99 years | 
| QoL (IPSS) Data- Evaluation of Urinary Symptoms and Incontinence | Patient-reported qualify of life (QoL) questionnaire answers to assess changes in urinary symptoms and urinary incontinence: IPSS (International Prostate Symptom Score) Minimum score=0, Maximum score=35. Higher scores indicate a worse outcome. | Lifelong up to 99 years | 
| QoL (EPIC) Data- Evaluation of Urinary Symptoms and Incontinence | Patient-reported qualify of life (QoL) questionnaire answers to assess changes in urinary symptoms and urinary incontinence: 2 questions from EPIC-26 (Expanded Prostate Cancer Index Composite) | Lifelong up to 99 years | 
| Survival Data- Percentage of participants without Biochemical Recurrence | in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from biochemical recurrence. | Lifelong up to 99 years | 
| Survival Data- Percentage of participants without additional Salvage Treatment | in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from undergoing any additional salvage treatment. | Lifelong up to 99 years | 
| Survival Data- Percentage of participants without additional Systemic Therapy | in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from undergoing any additional systemic therapy. | Lifelong up to 99 years | 
| Survival Data- Percentage of participants without Distant Metastases | in men with prostate cancer, survival data will be captured to identify percentage of participants who are free from distant metastases. | Lifelong up to 99 years | 
| Survival Data- Number of patients with disease-specific mortality | in men with prostate cancer, survival data will be captured to identify freedom from disease-specific mortality. | Lifelong up to 99 years | 
| Survival Data- Overall mortality | in men with prostate cancer, survival data will be captured to identify freedom from overall mortality. | Lifelong up to 99 years | 
| Financial Data- Total Costs | Financial tracking information such total cost to patient, private insurance, public insurance) associated with treatment and visit will be collected. | Between 0 and 3 months post Tulsa Procedure | 
| Survival Data - Percentage of patients that got additional treatments for BPH | Additional treatments related to urinary symptoms attributed to BPH will be collected, including types of treatments. | Lifelong up to 99 years | 
| Survival Data - Dates of additional treatments undertaken for BPH patients | Additional treatments related to urinary symptoms attributed to BPH will be collected, including dates of these treatments. | Lifelong up to 99 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive, Prostate ablation, high intensity transurethral ultrasound ablation, MRI-guided, real-time temperature feedback control, prostate cancer, BPH, TULSA