MRI-guided ultrasound treatment for intermediate grade prostate cancer
Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System
This study is testing a new ultrasound treatment for men aged 45 to 80 with intermediate grade prostate cancer to see if it safely destroys tumor cells and helps them recover better than surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05438563 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of MRI-guided transurethral ultrasound ablation (TULSA) in men aged 45 to 80 with intermediate grade prostate cancer. The procedure utilizes MRI imaging to guide ultrasound waves that target and destroy tumor cells, potentially offering a minimally invasive alternative to surgery. Participants will undergo various assessments, including quality of life metrics and follow-up evaluations over a two-year period to monitor outcomes. The study aims to provide insights into the procedure's impact on patient recovery and economic benefits.
Who should consider this trial
Good fit: Ideal candidates are males aged 45-80 with biopsy-confirmed intermediate-risk prostate cancer and a life expectancy of over 10 years.
Not a fit: Patients with tumors located more than 30 mm from the prostatic urethra or those unable to undergo MRI or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with intermediate grade prostate cancer, improving their quality of life.
How similar studies have performed: While the use of MRI-guided ultrasound ablation is a novel approach, similar minimally invasive techniques have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David A Woodrum, MD, PhD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.