Clinical trial NCT05001477: Customized TULSA-PRO Ablation Registry
Official title: Customized TULSA-PRO Ablation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Benign Prostatic Hyperplasia
Keywords: Prostate ablation
high intensity transurethral ultrasound ablation
MRI-guided
minimally invasive
real-time temperature feedback control
prostate cancer
BPH
TULSA
Lead sponsor: Profound Medical Inc.
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include as many eligible subjects as willing to participate who have undergone or will be undergoing the TULSA Procedure.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria

1. Male
2. \>18 years old
3. Candidate for TULSA-PRO treatment
4. willing and able to sign the Informed Consent form

Exclusion Criteria:

None.

Primary outcomes:
measure: Rate of complications
timeFrame: 5 years
measure: Freedom from treatment failure
timeFrame: 5 years
Secondary outcomes:
measure: Complications Data
timeFrame: Lifelong up to 99 years
measure: Biopsy Data
timeFrame: Between 6 and 18 months post TULSA Procedure
measure: Prostate Volume Reduction on MRI
timeFrame: Between 6 and 18 months post TULSA Procedure
measure: Suspicious cancerous lesions on MRI
timeFrame: Between 6 and 18 months post TULSA Procedure
measure: PSA Data
timeFrame: Lifelong up to 99 years
measure: QoL (IIEF-5) Data-Evaluation of Erectile Dysfunction, Ejaculatory function and erection firmness
timeFrame: Lifelong up to 99 years
measure: QoL (IIEF-15) Data-Evaluation of Erectile Dysfunction, Ejaculatory function and erection firmness
timeFrame: Lifelong up to 99 years
measure: QoL (IPSS) Data- Evaluation of Urinary Symptoms and Incontinence
timeFrame: Lifelong up to 99 years
measure: QoL (EPIC) Data- Evaluation of Urinary Symptoms and Incontinence
timeFrame: Lifelong up to 99 years
measure: Survival Data- Percentage of participants without Biochemical Recurrence
timeFrame: Lifelong up to 99 years
measure: Survival Data- Percentage of participants without additional Salvage Treatment
timeFrame: Lifelong up to 99 years
measure: Survival Data- Percentage of participants without additional Systemic Therapy
timeFrame: Lifelong up to 99 years
measure: Survival Data- Percentage of participants without Distant Metastases
timeFrame: Lifelong up to 99 years
measure: Survival Data- Number of patients with disease-specific mortality
timeFrame: Lifelong up to 99 years
measure: Survival Data- Overall mortality
timeFrame: Lifelong up to 99 years
measure: Financial Data- Total Costs
timeFrame: Between 0 and 3 months post Tulsa Procedure
measure: Survival Data - Percentage of patients that got additional treatments for BPH
timeFrame: Lifelong up to 99 years
measure: Survival Data - Dates of additional treatments undertaken for BPH patients
timeFrame: Lifelong up to 99 years
Other outcomes:
Locations:
city: West Hills
country: United States
facility: RadNet's Liberty Pacific West Hills Facility
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: York
country: United States
facility: Wellspan Health
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Urology Place
state: Texas
Study officials:
References: