Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients with Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
Phase 2
Recruiting
- Conditions
- Prostate cancerProstate carcinoma10038597
- Registration Number
- NL-OMON42845
- Lead Sponsor
- Profound Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Men diagnosed with biopsy-proven, organ-confined, low- to intermediate-risk prostate cancer will be eligible for participation in this study, provided they have not received prior treatment of their prostate cancer.
Exclusion Criteria
Extraprostatic extension, lesion within 3mm of the urethra or sphincter plane, previous TURP, calcifications or cysts in the prostate, use of hormones
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Safety Endpoint: Frequency and severity of adverse events deemed related or<br /><br>possibly related to the TULSA-PRO device, procedure, or ablative process will<br /><br>be evaluated and reported in accordance with the Common Terminology Criteria<br /><br>for Adverse Events (CTCAE) standard published by the National Cancer Institute<br /><br>(NCI).<br /><br>* Efficacy Endpoint: Prostate ablation efficacy will be evaluated using the<br /><br>proportion of patients achieving a PSA nadir * 25% of the pre-treatment<br /><br>baseline value.</p><br>
- Secondary Outcome Measures
Name Time Method