Status:
RECRUITING
MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Low to Intermediate Grade Prostate Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Eligibility:
MALE
45-80 years
Phase:
NA
Brief Summary
This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate gr...
Detailed Description
PRIMARY OBJECTIVE: I. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) low to intermediat...
Eligibility Criteria
Inclusion
- Male
- Age 45-80 years, with \> 10 years life expectancy
- Biopsy-confirmed, NCCN \[Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3\] intermediate-risk prostate cancer
- Stage =\< T2c, N0, M0
- International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy \[minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category \>= 3 lesion\]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
- Prostate specific antigen (PSA) =\< 20 ng/mL reported within 3 months of baseline
- Treatment naive
- Planned ablation volume \< 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
Exclusion
- Inability to undergo MRI or general anaesthesia
- Suspected tumour \> 30 mm from the prostatic urethra or \< 14 mm from the prostatic urethra
- Prostate calcifications \> 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
- Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit
- Unresolved urinary tract infection or prostatitis
- History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- Artificial urinary sphincter, penile implant or intraprostatic implant
- Less than 10 years life expectancy
- Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
- Inability or unwillingness to provide informed consent
- History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05438563
Start Date
April 6 2022
End Date
March 7 2027
Last Update
September 9 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905