Registry for patients undergoing TULSA procedure for prostate conditions
Official title: Customized TULSA-PRO Ablation Registry
Run by Profound Medical Inc. · NCT05001477 · Data updated 2026-11-12
This study is tracking patients who have had the TULSA procedure for prostate issues to see how safe and effective it is and how it affects their quality of life over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 1000 (estimated) |
| Sponsor | Profound Medical Inc. Academic / other |
| Locations | 5 sites (West Hills, California and 4 other locations) |
| Status | Recruiting |
| Started | October 27, 2021 |
| Main results expected | October 2026 |
| Study ends | October 2061 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT05001477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males over 18 years old who are candidates for the TULSA-PRO treatment.
✕Probably not a fit
Patients who are not candidates for the TULSA procedure will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry collects data from patients who are undergoing or have undergone the transurethral ultrasound ablation (TULSA) procedure for prostate cancer and benign prostatic hyperplasia. The aim is to evaluate the real-world safety and efficacy of the TULSA procedure, as well as its impact on patients' quality of life over time. Patients will be followed up at regular intervals for several years, providing valuable insights into treatment outcomes and practice trends. The registry will help optimize patient care based on collected evidence.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of TULSA outcomes, leading to improved patient care and quality of life.
How similar studies have gone: Other studies on similar minimally invasive procedures have shown promising outcomes, indicating potential for success in this registry.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
RadNet's Liberty Pacific West Hills Facility
West Hills, California, United States Recruiting -
Mayo Clinic Jacksonville
Jacksonville, Florida, United States Recruiting -
Wellspan Health
York, Pennsylvania, United States Recruiting -
University of Texas Southwestern Medical Center
Dallas, Texas, United States Recruiting -
Urology Place
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Gina Clarke
- Email: gclarke@profoundmedical.com
- Phone: 416-689-8156
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sonablate HIFU Registry for Prostate Cancer and BPH
This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.
-
MRI-DTI look at the urethral sphincter ring and prostate base shape
This imaging study tests how the male urethral internal sphincter ring appears on MRI-DTI and how it relates to prostate base morphology in men undergoing clinically indicated MRI.
-
PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.
-
Lower-dose radiation to parts of the prostate for some men with prostate cancer
This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.
-
Bioblation: Combined biopsy and laser treatment for prostate symptoms and suspected cancer
A single-session procedure (Bioblation) combines a trans-perineal prostate biopsy with laser ablation to relieve severe LUTS and treat likely low- to favorable intermediate-risk prostate cancer.
-
PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance
This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.