Customized TULSA-PRO Ablation Registry (CARE)

November 5, 2024 updated by: Profound Medical Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • West Hills, California, United States, 91307
        • Recruiting
        • RadNet's Liberty Pacific West Hills Facility
        • Contact:
        • Principal Investigator:
          • Robert Princenthal, MD
        • Sub-Investigator:
          • Martin Cohen, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Principal Investigator:
          • Chandler Dora, MD
        • Contact:
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Wellspan Health
        • Contact:
        • Principal Investigator:
          • Edward Steiner, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Daniel Costa, MD
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Urology Place
        • Principal Investigator:
          • Naveen Kella, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: 5 years
estimating the rate of complications (Clavien-Dindo grades III - IV) attributable to the TULSA Procedure
5 years
Freedom from treatment failure
Time Frame: 5 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Between 6 and 18 months post TULSA Procedure
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
Time Frame: Between 6 and 18 months post TULSA Procedure
Multi-parametric prostate MRI data to measure prostate volume reduction
Between 6 and 18 months post TULSA Procedure
Suspicious cancerous lesions on MRI
Time Frame: Between 6 and 18 months post TULSA Procedure
Identify presence of any suspicious (i.e. suspected for cancer) lesions.
Between 6 and 18 months post TULSA Procedure
PSA Data
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years

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
Time Frame: Lifelong up to 99 years

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
Time Frame: Lifelong up to 99 years

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
Time Frame: Lifelong up to 99 years

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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Between 0 and 3 months post Tulsa Procedure
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
Time Frame: Lifelong up to 99 years
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
Time Frame: Lifelong up to 99 years
Additional treatments related to urinary symptoms attributed to BPH will be collected, including dates of these treatments.
Lifelong up to 99 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profound Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2061

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCP-10250

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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