MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate Cancer

Launched by MAYO CLINIC · Jun 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called MRI-guided transurethral ultrasound ablation (TULSA) to treat men with intermediate grade prostate cancer. This method uses advanced imaging technology (MRI) to help direct high-energy sound waves to destroy cancer cells in the prostate without the need for traditional surgery. The goal is to see if this approach is safe and effective, potentially allowing patients to avoid more invasive treatments while improving their quality of life.

To participate in the trial, you must be a man aged between 45 and 80, with a confirmed diagnosis of intermediate risk prostate cancer that meets specific criteria. This includes having a certain cancer grade as determined by a biopsy and a prostate-specific antigen (PSA) level of 20 ng/mL or lower. Participants can expect a minimally invasive procedure, and they will be closely monitored throughout the study. It’s important to note that not everyone will qualify; for instance, individuals with certain urinary conditions or those who cannot undergo an MRI cannot participate. This trial is currently recruiting participants, so if you or a loved one think you might be eligible, it could be a good opportunity to explore.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male
• • Age 45-80 years, with \> 10 years life expectancy
• • Biopsy-confirmed, NCCN \[favorable Gleason grade (GG) 2 and unfavorable GG3\] intermediate-risk prostate cancer
• • Stage =\< T2c, N0, M0
• • International Society of Urological Pathology (ISUP) grade group 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 Criteria:
• • 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