Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System
Mayo Clinic
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 grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
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 intermediate-risk prostate cancer. SECONDARY OBJECTIVE: I. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire. OUTLINE: Patients undergo MRI-guided TULSA. Patients may also undergo digital rectal exam (DRE), cystoscopy, biopsy, bone scan, prostate s…
Eligibility
- Age range
- 45–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 o…
Interventions
- ProcedureMRI-Guided Transurethral Ultrasound Ablation
Undergo MRI-Guided TULSA
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureDigital Rectal Examination
Undergo DRE
- ProcedureCystoscopy
Undergo cystoscopy
- ProcedureBiopsy
Undergo biopsy
- ProcedureBone Scan
Undergo bone scan
- ProcedurePSMA PET Scan
Undergo PSMA PET
Location
- Mayo Clinic in RochesterRochester, Minnesota